Trial Outcomes & Findings for Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness (NCT NCT01782378)

Results Overview

Repeat a series of numbers, exactly as spoken, in the same order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, testing is discontinued. Scoring: 2 points both trials per set; 1 point 1 trial; 0 points failed both trials Forwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Results posted on

2020-01-22

Participant Flow

VA Boston Healthcare System, Jamaica Plain Campus, Boston, MA Recruitment January 9, 2015 (date of first enrolled participant) - March 2018 San Francisco VA Medical Center, San Francisco, CA Second site Recruitment started December 2016

Both Sites Pre-Screened by Telephone or In-Office = 197; Enrolled, after Pre-Screening (Signed informed consent form (ICF/HIPAA) = 96; Screened, after Enrollment (Neuropsychological/Screening Tests administered) = 96 \*must meet inclusion criteria to be randomized; Randomized, after Screening (Assignment to Group) = 63

Participant milestones

Participant milestones
Measure	Real LED Treatment Series Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial, near-infrared (NIR), 830nm LED Helmet and two light-emitting diode (LED) intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
First Series STARTED	32	31
First Series COMPLETED	25	23
First Series NOT COMPLETED	7	8
Second Series STARTED	31	32
Second Series COMPLETED	5	0
Second Series NOT COMPLETED	26	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Real LED Treatment Series Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial, near-infrared (NIR), 830nm LED Helmet and two light-emitting diode (LED) intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
First Series Lost to Follow-up	7	8
Second Series Partial Crossover Design- no Sham 2nd	0	25
Second Series Lost to Follow-up	8	7
Second Series Did not choose to complete S2 Optional	18	0

Baseline Characteristics

Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Total n=48 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 5.6 • n=5 Participants	52.4 years STANDARD_DEVIATION 6.6 • n=7 Participants	52 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants
Education	14.2 years STANDARD_DEVIATION 1.99 • n=5 Participants	14.2 years STANDARD_DEVIATION 1.90 • n=7 Participants	14.2 years STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Repeat a series of numbers, exactly as spoken, in the same order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, testing is discontinued. Scoring: 2 points both trials per set; 1 point 1 trial; 0 points failed both trials Forwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Digit Span Forwards T1 [within 1-2 weeks before LED treatment series]	8.7 units on a scale Standard Deviation 2.16	9.22 units on a scale Standard Deviation 2.47
Digit Span Forwards T2 [within 1 week after LED treatment series]	8.33 units on a scale Standard Deviation 2.18	9.36 units on a scale Standard Deviation 2.68
Digit Span Forwards T3 [1 month after LED treatment series]	9.11 units on a scale Standard Deviation 2.19	9.8 units on a scale Standard Deviation 2.97

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Repeat a series of numbers, in reverse order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, the test is discontinued. Scoring: 2 points both trials correct for each set; 1point 1 trial correct; 0 points no trials Backwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Digit Span Backwards T1 [within 1-2 weeks before LED treatment series]	5.78 units on a scale Standard Deviation 1.78	6.39 units on a scale Standard Deviation 2.84
Digit Span Backwards T2 [within 1 week after LED treatment series]	7.21 units on a scale Standard Deviation 2.57	7.73 units on a scale Standard Deviation 5.67
Digit Span Backwards T3 [1 month after LED treatment series]	6.94 units on a scale Standard Deviation 1.73	7 units on a scale Standard Deviation 2.98

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Total (Forwards+Backwards); measures Attention/Executive Function; working memory with a min score of 0 and a max score of 28; higher score = better outcome

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Digit Span Total Forward + Backwards T1 [within 1-2 weeks before LED treatment series]	14.48 units on a scale Standard Deviation 3.5	15.61 units on a scale Standard Deviation 4.72
Digit Span Total Forward + Backwards T2 [within 1 week after LED treatment series]	15.54 units on a scale Standard Deviation 4.37	15.86 units on a scale Standard Deviation 4.70
Digit Span Total Forward + Backwards T3 [1 month after LED treatment series]	16.06 units on a scale Standard Deviation 3.52	16.79 units on a scale Standard Deviation 5.15

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Delis-Kaplan Executive Function (DKEFS) Trails 2; Number Sequencing; measures Attention/Executive Function Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Trails Condition 2 T3 [1 month after LED treatment series	34 seconds Standard Deviation 14.02	33.26 seconds Standard Deviation 14.55
Trails Condition 2 T1 [within 1-2 weeks before LED treatment series]	34.56 seconds Standard Deviation 9.79	39.61 seconds Standard Deviation 22.03
Trails Condition 2 T2 [within 1 week after LED treatment series]	34.5 seconds Standard Deviation 8.39	37.59 seconds Standard Deviation 16.22

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Delis-Kaplan Executive Function (DEKFS) Trails 4; Number-Letter Switching; measures Attention/Executive Function Reaction Time lower is better Connect numbers and letters, alternating between numbers and letters. (1-A-2-B...) as quickly as possible. Ends at P.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Trails Condition 4 T1 [within 1-2 weeks before LED treatment series]	87.72 seconds Standard Deviation 35.13	97.74 seconds Standard Deviation 46.33
Trails Condition 4 T2 [within 1 week after LED treatment series]	88.83 seconds Standard Deviation 31.01	79.63 seconds Standard Deviation 43.70
Trails Condition 4 T3 [1 month after LED treatment series	80.61 seconds Standard Deviation 37.66	89.68 seconds Standard Deviation 47.69

PRIMARY outcome

Timeframe: Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series

Population: missing data points

Color-Word Interference Test Trial 3; measures Attention/Executive Function; inhibition Reaction Time lower = better outcome Name the color ink each word is printed in for a series of words, as quickly as possible.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Stroop Inhibition (Trial 3) T2 [within 1 week after LED treatment series]	59.54 seconds Standard Deviation 14.60	57.81 seconds Standard Deviation 14.04
Stroop Inhibition (Trial 3) T3 [1 month after LED treatment series]	56.33 seconds Standard Deviation 13.45	60.63 seconds Standard Deviation 17.98
Stroop Inhibition (Trial 3) T1 [Within 1-2 weeks before LED treatment series]	60.8 seconds Standard Deviation 14.16	60.83 seconds Standard Deviation 17.94

PRIMARY outcome

Timeframe: Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series

Population: missing data points

Color-Word Interference Test Trial 4 (Inhibition/Switching); measures Attention/Executive Function Reaction Time lower = better outcome Participants must sometimes name the color ink in which the word (color) is printed or, if there is a box around the word, they must read the word.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Stroop Inhibition/Switching T1 [Within 1-2 weeks before LED treatment series]	72.04 seconds Standard Deviation 32.73	68.22 seconds Standard Deviation 17.82
Stroop Inhibition/Switching T2 [within 1 week after LED treatment series]	68.5 seconds Standard Deviation 30.13	62.46 seconds Standard Deviation 14.89
Stroop Inhibition/Switching T3 [1 month after LED treatment series]	72.44 seconds Standard Deviation 45.04	59 seconds Standard Deviation 13.32

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

CVLT-II Total Trials 1-5, measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list A read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
California Verbal Learning Test -II (CVLT-II) Total Trials 1-5 T2 [within 1 week after LED treatment series]	47.96 units on a scale Standard Deviation 10.13	46.05 units on a scale Standard Deviation 10.88
California Verbal Learning Test -II (CVLT-II) Total Trials 1-5 T3 [1 month after LED treatment series]	50 units on a scale Standard Deviation 9.06	50.42 units on a scale Standard Deviation 13.6
California Verbal Learning Test -II (CVLT-II) Total Trials 1-5 T1 [within 1-2 weeks before LED treatment series]	45.48 units on a scale Standard Deviation 7.85	41.09 units on a scale Standard Deviation 9.66

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

California Verbal Learning Test -II, Short Delay Free Recall, measures Memory; with min score of 0 and a max score of 16; higher score = better outcome A second list B is presented for one trial of recall before asking participants to recall items from the first list A. Number of items recalled from list A is scored.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
CVLT-II, Short Delay Free Recall T1 [within 1-2 weeks before LED treatment series]	9.52 units on a scale Standard Deviation 3.68	8.13 units on a scale Standard Deviation 2.79
CVLT-II, Short Delay Free Recall T3 [1 month after LED treatment series]	10.9 units on a scale Standard Deviation 2.92	10.74 units on a scale Standard Deviation 3.36
CVLT-II, Short Delay Free Recall T2 [within 1 week after LED treatment series]	10.38 units on a scale Standard Deviation 2.8	9.5 units on a scale Standard Deviation 2.76

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

California Verbal Learning Test -II, Short Delay Cued Recall, measures Learning/Memory; with a min score of 0 and a max score of 16; higher score = better outcome Participants are now asked to recall items from list A again, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
CVLT-II, Short Delay Cued Recall T1 [within 1-2 weeks before LED treatment series]	11 units on a scale Standard Deviation 2.36	10.22 units on a scale Standard Deviation 3.29
CVLT-II, Short Delay Cued Recall T2 [within 1 week after LED treatment series]	12.04 units on a scale Standard Deviation 2.73	10.82 units on a scale Standard Deviation 2.44
CVLT-II, Short Delay Cued Recall T3 [1 month after LED treatment series]	12.56 units on a scale Standard Deviation 2.26	11.84 units on a scale Standard Deviation 2.75

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

California Verbal Learning Test- II, Long Delay (20 min) Free Recall, measures Memory with a min score of 0 and a max score of 16; higher score = better outcome After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
CVLT-II Long Delay Free Recall T1 [within 1-2 weeks before LED treatment series]	10 units on a scale Standard Deviation 2.78	8.49 units on a scale Standard Deviation 3.5
CVLT-II Long Delay Free Recall T2 [within 1 week after LED treatment series]	11 units on a scale Standard Deviation 3.14	9.82 units on a scale Standard Deviation 2.86
CVLT-II Long Delay Free Recall T3 [1 month after LED treatment series]	11.4 units on a scale Standard Deviation 2.75	10.21 units on a scale Standard Deviation 3.44

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

California Verbal Learning Test- II, Long Delay (20 min) Cued Recall measures Memory; with a min score of 0 and a max score of 16; higher score = better outcome After 20 minute delay participant is given cues (4 categories) and asked to recall the words within each category. Total number of items recalled across all categories.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
CVLT-II Long Delay Cued Recall T1 [within 1-2 weeks before LED treatment series]	11 units on a scale Standard Deviation 2.31	9.83 units on a scale Standard Deviation 3.04
CVLT-II Long Delay Cued Recall T3 [1 month after LED treatment series]	12.56 units on a scale Standard Deviation 2.23	11.48 units on a scale Standard Deviation 3.01
CVLT-II Long Delay Cued Recall T2 [within 1 week after LED treatment series]	11.9 units on a scale Standard Deviation 2.85	10.96 units on a scale Standard Deviation 2.89

PRIMARY outcome

Timeframe: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

CPT; False Alarms (Administered on laptop computer) measures Selective and Sustained Attention percent errors; lower = better outcome Participant presses space bar when an X appears on screen. False alarms is number of errors made (responding to non-targets), reported as percentage.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Conner's Continuous Performance Test II (CPT) False Alarms T1 [within 1-2 weeks before LED treatment series]	30.48 percent errors Standard Deviation 18.51	24.14 percent errors Standard Deviation 16.84
Conner's Continuous Performance Test II (CPT) False Alarms T2 [within 1 week after LED treatment series]	26.16 percent errors Standard Deviation 19.99	18.32 percent errors Standard Deviation 13.12
Conner's Continuous Performance Test II (CPT) False Alarms T3 [1 month after LED treatment series]	26.72 percent errors Standard Deviation 17	17.22 percent errors Standard Deviation 14.45

PRIMARY outcome

Timeframe: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Conner's Continuous Performance Test II; Mean Correct Detections, Reaction Time, (Administered on laptop computer) measures Selective and Sustained Attention; shorter = better outcome Participant must press the space bar when they see an X. Reaction Time for correct responses only.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
CPT Correct Detections, Reaction Time (RT) T3 [1 month after LED treatment series]	457.02 seconds Standard Deviation 68.56	467.5 seconds Standard Deviation 65.35
CPT Correct Detections, Reaction Time (RT) T1 [within 1-2 weeks before LED treatment series]	477.41 seconds Standard Deviation 65.82	464.62 seconds Standard Deviation 71.82
CPT Correct Detections, Reaction Time (RT) T2 [within 1 week after LED treatment series]	476.38 seconds Standard Deviation 77.51	470.82 seconds Standard Deviation 76.55

PRIMARY outcome

Timeframe: within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Conner's Continuous Performance Test II (CPT); D' (sensitivity index) (Administered on laptop computer) measures Selective and Sustained Attention; ability to detect the signal (x) within noise; values range -2 to 2; higher value better Value d' is a measure of the difference between the signal (X) and noise (non-target letters) distributions, assessing the participant's discriminative power.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Conner's Continuous Performance Test II (CPT), D' T3 [1 month after LED treatment series]	0.24 difference between distributions Standard Deviation 1.49	-1.13 difference between distributions Standard Deviation 2.65
Conner's Continuous Performance Test II (CPT), D' T1 [within 1-2 weeks before LED treatment series]	1.84 difference between distributions Standard Deviation 7.38	-0.67 difference between distributions Standard Deviation 2.24
Conner's Continuous Performance Test II (CPT), D' T2 [within 1 week after LED treatment series]	0.499 difference between distributions Standard Deviation 1.412	-.836 difference between distributions Standard Deviation 2.36

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

ROCFT; Immediate Recall measures Visuospatial memory with min 0 and max 36; higher score better outcome Participant is presented with a figure. They are asked to copy the figure. Then they are immediately asked to recall and draw the figure. Figure is scored on 18 units; up to 2 points per unit Scoring based on accuracy and placement of figure parts: A score of 0, 0.5 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall T1 [within 1-2 weeks before LED treatment series]	16.16 units on a scale Standard Deviation 5.9	14.87 units on a scale Standard Deviation 5.76
Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall T2 [within 1 week after LED treatment series]	20.56 units on a scale Standard Deviation 5.78	18.14 units on a scale Standard Deviation 6.39
Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall T3 [1 month after LED treatment series	22.22 units on a scale Standard Deviation 6.73	18.658 units on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data point

Rey Osterrieth Complex Figure Test (ROCFT); Delayed (20-min) Recall measures Visuospatial memory with min 0 and max 36; higher = better outcome Participant is asked to draw the figure from memory after a 20 minute delay (other tasks completed during this time). Figure has 18 units; Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, .5 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per unit.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
ROCFT, Delayed Recall T2 [within 1 week after LED treatment series]	18.96 units on a scale Standard Deviation 5.66	17.5 units on a scale Standard Deviation 6.28
ROCFT, Delayed Recall T3 [1 month after LED treatment series]	21.64 units on a scale Standard Deviation 6.11	19 units on a scale Standard Deviation 6.41
ROCFT, Delayed Recall T1 [within 1-2 weeks before LED treatment series]	15.75 units on a scale Standard Deviation 6.24	14.28 units on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

BDI; 21 item Questionnaire; Mood. With min 0 and max 63; 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Beck Depression Inventory (BDI) T1 [1-2 weeks before LED treatment series]	19.72 units on a scale Standard Deviation 11.19	15.17 units on a scale Standard Deviation 11.5
Beck Depression Inventory (BDI) T2 [within 1 week after LED treatment series]	18.91 units on a scale Standard Deviation 10.66	11.95 units on a scale Standard Deviation 9.78
Beck Depression Inventory (BDI) T3 [1 month after LED treatment series]	17.06 units on a scale Standard Deviation 10.96	13.05 units on a scale Standard Deviation 10.83

SECONDARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Post Traumatic Stress Disorder 17-item, symptom questionnaire; higher scores indicates greater endorsement of symptoms with min 17 and max 85; Reliable decrease 5-10; Clinically meaningful decrease 10-20 points (Monson et al., 2008); Lower scores = better outcome Score ranges from 1-5 for each item.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
PCL-Civilian Survey T1 [within 1-2 weeks before LED treatment series]	48.83 units on a scale Standard Deviation 13.6	40.30 units on a scale Standard Deviation 16.12
PCL-Civilian Survey T2 [within 1 week after LED treatment series]	42.04 units on a scale Standard Deviation 14.45	35.43 units on a scale Standard Deviation 12.68
PCL-Civilian Survey T3 [1 month after LED treatment series]	42.5 units on a scale Standard Deviation 14.96	36.32 units on a scale Standard Deviation 14.06

SECONDARY outcome

Timeframe: within 1-2 weeks of LED treatment, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Visual Analog Pain Rating Scale (VAS); Current Pain Rating scale of 1-10; lower score = better outcome \*must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Visual Analog Pain Rating T1 [1-2 weeks before LED treatment series]	3.48 units on a scale Standard Deviation 2.06	3.59 units on a scale Standard Deviation 2.51
Visual Analog Pain Rating T2 [within 1 week after LED treatment series]	3.06 units on a scale Standard Deviation 2.17	2.73 units on a scale Standard Deviation 2.28
Visual Analog Pain Rating T3 [1 month after LED treatment series]	3.14 units on a scale Standard Deviation 2.27	2.4 units on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Short Form McGill Pain Questionnaire; Pain Rating (for the last 30 days) with min 0 and max 45; lower = better outcome Participant rates 15 types of pain (None = 0, mild = 1, moderate = 2, severe = 3). Totaled for all types of pain.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Short Form McGill Pain Questionnaire T3 [1 month after LED treatment series]	9.67 units on a scale Standard Deviation 7.21	8.63 units on a scale Standard Deviation 6.07
Short Form McGill Pain Questionnaire T1 [1-2 weeks before LED treatment series]	9.58 units on a scale Standard Deviation 4.79	10.74 units on a scale Standard Deviation 8.04
Short Form McGill Pain Questionnaire T2 [within 1 week after LED treatment series]	11.38 units on a scale Standard Deviation 7.94	9 units on a scale Standard Deviation 5.54

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Global Sleep Score with min score of 0 and max score of 27; lower score = better outcome 9 item questionnaire- make up 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) with a min of 0 and max of 3 per component. Global score is total of the 7 component scores.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Pittsburgh Sleep Quality Index (PSQI) T1 [1-2 weeks before LED treatment series]	10.12 units on a scale Standard Deviation 3.82	8.39 units on a scale Standard Deviation 5.56
Pittsburgh Sleep Quality Index (PSQI) T2 [wihtin 1-2 weeks after LED treatment series]	9.54 units on a scale Standard Deviation 4.82	7.64 units on a scale Standard Deviation 4.42
Pittsburgh Sleep Quality Index (PSQI) T3 [1 month after LED treatment series	9.11 units on a scale Standard Deviation 4.13	7.05 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Measure of Sleepiness; Participant indicates current level of sleepiness on a scale of 0 extremely alert to 10 extremely sleepy; lower score = better outcome

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Karolinska Sleepiness Scale T1 [1-2 weeks before LED treatment series]	5.08 score on a scale Standard Deviation 2.04	4.35 score on a scale Standard Deviation 2.06
Karolinska Sleepiness Scale T2 [within 1 week after LED treatment series]	4.58 score on a scale Standard Deviation 2.12	4.27 score on a scale Standard Deviation 1.86
Karolinska Sleepiness Scale T3 [1 month after LED treatment series	5.33 score on a scale Standard Deviation 2.2	3.53 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

36 Question General Health Survey/Questionnaire for Veterans; Physical Composite Score (PCS) measures endorsement of physical health symptoms related to physical problems which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower = better outcome.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Short Form-36V Plus (PCS) T1 [1-2 weeks before LED treatment series]	-.85 Z-Score Standard Deviation 1.08	-.83 Z-Score Standard Deviation 1.13
Short Form-36V Plus (PCS) T2 [within 1 week after LED treatment series]	-1.06 Z-Score Standard Deviation .96	-.76 Z-Score Standard Deviation .904
Short Form-36V Plus (PCS) T3 [1 month after LED treatment series]	-.91 Z-Score Standard Deviation .91	-.61 Z-Score Standard Deviation 1.15

SECONDARY outcome

Timeframe: within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment

Population: missing data points

36 Question General Health Survey/Questionnaire for Veterans; Mental Composite Score (MCS) measures endorsement of mental health symptoms which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower score is better (based on scoring of the Veterans RAND 36 item Health Survey (SV-36) formerly Veterans SF-36.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Short Form-36V Plus (MCS) T1 [1-2 weeks before LED treatment series]	-.64 Z-Score Standard Deviation 1.07	-.20 Z-Score Standard Deviation 1.3
Short Form-36V Plus (MCS) T2 [wihtin 1 week after LED Treatment series]	-.53 Z-Score Standard Deviation 1.2	-.078 Z-Score Standard Deviation 1.05
Short Form-36V Plus (MCS) T3 [1 month after LED treatment series	-.50 Z-Score Standard Deviation 1.12	-.34 Z-Score Standard Deviation 1.15

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Measures General Fatigue Levels; lower = better; General Fatigue Subscale = sum of items numbers 1, 5, 12 and 16 (max = 5, min =0 for each item) Max possible sum is 20.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Multidimensional Fatigue Inventory (MFI), General Score T1 [1-2 weeks before LED treatment series]	14.08 units on a scale Standard Deviation 2.71	11.83 units on a scale Standard Deviation 3.99
Multidimensional Fatigue Inventory (MFI), General Score T2 [within 1 week after LED treatment series]	13.9 units on a scale Standard Deviation 3.22	12.68 units on a scale Standard Deviation 4.59
Multidimensional Fatigue Inventory (MFI), General Score T3 [1 month after LED treatment series	14.44 units on a scale Standard Deviation 3.38	11.74 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Physical Score Subscale Measures Physical Fatigue Levels; lower = better outcome; sum of items numbers 2, 8, 14 and 20 (max = 5, min =0 for each item)

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Multidimensional Fatigue Inventory, Physical Score T1 [1-2 weeks before LED treatment series]	11.32 units on a scale Standard Deviation 4.4	11.57 units on a scale Standard Deviation 4.24
Multidimensional Fatigue Inventory, Physical Score T2 [within 1 week after LED treatment series]	11.5 units on a scale Standard Deviation 2.9	10.73 units on a scale Standard Deviation 3.81
Multidimensional Fatigue Inventory, Physical Score T3 [1 month after LED treatment series	11.83 units on a scale Standard Deviation 3.6	11 units on a scale Standard Deviation 3.66

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Reduced Activity Subscale measures fatigue levels during activity; lower = better outcome; sum of items numbers 3, 6, 10 and 17 (max = 5, min =0 for each item) Max possible sum is 20.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Multidimensional Fatigue Inventory, Reduced Activity Score T1 [1-2 weeks before LED treatment series]	11.52 units on a scale Standard Deviation 3.41	10.48 units on a scale Standard Deviation 4.57
Multidimensional Fatigue Inventory, Reduced Activity Score T2 [within 1 week after LED treatment series]	11.21 units on a scale Standard Deviation 3.62	11.05 units on a scale Standard Deviation 3.54
Multidimensional Fatigue Inventory, Reduced Activity Score T3 [1 month after LED treatment series	11.6 units on a scale Standard Deviation 2.67	9.47 units on a scale Standard Deviation 3.27

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Reduced Motor Activity subscale measures if fatigue affects motivation levels; lower score = better outcome; sum of items numbers 4, 9, 15, and 18 (max = 5, min =0 for each item) Max possible sum is 20.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Multidimensional Fatigue Inventory, Reduced Motivation Activity T2 [within 1 week after LED treatment series]	10.67 units on a scale Standard Deviation 3.44	9.96 units on a scale Standard Deviation 4.08
Multidimensional Fatigue Inventory, Reduced Motivation Activity T3 [1 month after LED treatment series	11.28 units on a scale Standard Deviation 2.8	10.32 units on a scale Standard Deviation 3.6
Multidimensional Fatigue Inventory, Reduced Motivation Activity T1 [1-2 weeks before LED treatment series]	10.44 units on a scale Standard Deviation 2.57	9.78 units on a scale Standard Deviation 4.34

SECONDARY outcome

Timeframe: 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment

Population: missing data points

Mental Fatigue subscale measures mental fatigue levels; lower = better outcome; sum of items numbers 7, 11, 13 and 19 (max = 5, min =0 for each item) Max possible sum is 20.

Outcome measures

Outcome measures
Measure	Real LED Treatment Series n=25 Participants Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.	Sham LED Treatment Series n=23 Participants Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical.
Multidimensional Fatigue Inventory, Mental Fatigue T1 [1-2 weeks before LED treatment series]	14.24 units on a scale Standard Deviation 3.37	12.83 units on a scale Standard Deviation 3.93
Multidimensional Fatigue Inventory, Mental Fatigue T2 [within 1 week after LED treatment series]	13.71 units on a scale Standard Deviation 3.9	12.5 units on a scale Standard Deviation 4.37
Multidimensional Fatigue Inventory, Mental Fatigue T3 [1 month after LED treatment series	13.72 units on a scale Standard Deviation 3.93	13.05 units on a scale Standard Deviation 3.39

Adverse Events

Real LED Treatment Series

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham LED Treatment Series

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Naeser, PhD

VA Boston Healthcare System, Jamaica Plain Campus, Boston, MA

Phone: 857-364-4030

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place