Trial Outcomes & Findings for LED Therapy for the Treatment of Concussive Brain Injury (NCT NCT02383472)

Last Updated: 2018-07-26

Results Overview

The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

From baseline to 6 weeks

Results posted on

2018-07-26

Participant Flow

Recruitment began in the September of 2012 from the Concussion Clinic within the Department of Sports Medicine and lasted through the spring on 2016.

Participant milestones

Participant milestones
Measure	MedX Health Console Model 1100 The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Overall Study STARTED	23	30
Overall Study COMPLETED	22	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MedX Health Console Model 1100 The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

LED Therapy for the Treatment of Concussive Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MedX Health Console Model 1100 n=22 Participants The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo n=29 Participants Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.	Total n=51 Participants Total of all reporting groups
Age, Continuous	21.55 years STANDARD_DEVIATION 13.12 • n=5 Participants	21.21 years STANDARD_DEVIATION 13.25 • n=7 Participants	21.35 years STANDARD_DEVIATION 13.19 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	27 Participants n=7 Participants	49 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
Participants taking stimulant medications	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Migraine Headache	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Psychiatric hx Undefined	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Psychiatric hx Anxiety	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Psychiatric hx Depression	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Psychiatric hx PTSD	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Neurodevelopmental Diagnosis ADHD	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Neurodevelopmental Diagnosis Learning Disability	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Prior Concussions	3.5 Concussions n=5 Participants	2 Concussions n=7 Participants	2.5 Concussions n=5 Participants
Injury characteristics Sport-related concussion	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Injury characteristics Loss of Consciousness	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Injury characteristics Amnesia	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 6 weeks

Outcome measures

Outcome measures
Measure	MedX Health Console Model 1100 n=22 Participants The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo n=29 Participants Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. Reaction Time	-0.001 Units on a scale Standard Deviation 0.16	0.030 Units on a scale Standard Deviation 0.18
Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. Verbal Memory	-0.9 Units on a scale Standard Deviation 17.11	-5.78 Units on a scale Standard Deviation 12.08
Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. Visual Memory	3.52 Units on a scale Standard Deviation 14.82	-7.26 Units on a scale Standard Deviation 12.07
Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. Visual Motor Speed	-2.04 Units on a scale Standard Deviation 6.36	-5.15 Units on a scale Standard Deviation 5.04
Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. Symptom Score	10.14 Units on a scale Standard Deviation 10.13	11.44 Units on a scale Standard Deviation 19.07

SECONDARY outcome

Timeframe: From baseline to 3 weeks and from baseline to 6 weeks

This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs color-word interferences, made up of color naming, word reading, and inhibition, is measured in seconds, a smaller number represents a better outcome. Participants were given 90 seconds to complete color naming and word reading and 180 seconds to complete inhibition. D-KEFs trail making test, made up of number sequencing, letter sequencing, and number-letter sequencing, is measured in seconds, a faster speed (lower number) represents a better outcome. Participants were given 150 seconds to complete number and letter sequencing and 240 seconds to complete number-letter sequencing.

Outcome measures

Outcome measures
Measure	MedX Health Console Model 1100 n=22 Participants The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo n=29 Participants Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Color Naming - 3 Weeks	3.27 Seconds Standard Deviation 4.03	4.76 Seconds Standard Deviation 8.88
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Color Naming - 6 Weeks	3.76 Seconds Standard Deviation 5.12	4.07 Seconds Standard Deviation 9.00
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Word Reading - 3 Weeks	0.95 Seconds Standard Deviation 2.98	4.07 Seconds Standard Deviation 10.05
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Word Reading - 6 Weeks	1.71 Seconds Standard Deviation 3.73	3.44 Seconds Standard Deviation 13.98
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Inhibition - 3 Weeks	7.64 Seconds Standard Deviation 5.49	4.48 Seconds Standard Deviation 17.00
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Inhibition - 6 Weeks	32.62 Seconds Standard Deviation 9.13	31.59 Seconds Standard Deviation 14.73
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Number Sequencing - 3 weeks	-24.45 Seconds Standard Deviation 15.04	-21.17 Seconds Standard Deviation 17.55
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Letter Sequencing- 3 weeks	-28.41 Seconds Standard Deviation 14.06	-19.51 Seconds Standard Deviation 20.15
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Number-Letter Sequencing- 3 weeks	8.00 Seconds Standard Deviation 12.66	21.93 Seconds Standard Deviation 32.19
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Number Sequencing - 6 weeks	11.33 Seconds Standard Deviation 7.3	6.89 Seconds Standard Deviation 10.78
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Letter Sequencing- 6 weeks	6.86 Seconds Standard Deviation 4.29	10.59 Seconds Standard Deviation 9.49
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6. D-KEFs Number-Letter Sequencing- 6 weeks	12.95 Seconds Standard Deviation 13.28	19.81 Seconds Standard Deviation 30.34

SECONDARY outcome

Timeframe: From baseline to 3 weeks and from baseline to 6 weeks

Outcome measures

Outcome measures
Measure	MedX Health Console Model 1100 n=22 Participants The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo n=29 Participants Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6. D-KEFs Verbal Fluency- letters 3 weeks	-3.45 Correct responses Standard Deviation 6.52	-6.10 Correct responses Standard Deviation 8.26
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6. D-KEFs Verbal Fluency- letters 6 weeks	-6.71 Correct responses Standard Deviation 7.89	-9.89 Correct responses Standard Deviation 11.34
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6. D-KEFs Verbal Fluency- category 3 weeks	-1.14 Correct responses Standard Deviation 4.17	-0.03 Correct responses Standard Deviation 4.12
Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6. D-KEFs Verbal Fluency- category 6 weeks	-1.62 Correct responses Standard Deviation 4.09	-2.00 Correct responses Standard Deviation 4.62

SECONDARY outcome

Timeframe: From baseline to 3 weeks and from baseline to 6 weeks

This measure indicates the mean differences in total post concussion symptom score (PCSS) between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. The PCSS is a sum of severity scores from 0-6 (0=none, 6=severe) for 22 individual symptoms, like headache, neck pain, or drowsiness. The range for the PCSS is 0-132, a lower score represents a better outcome.

Outcome measures

Outcome measures
Measure	MedX Health Console Model 1100 n=22 Participants The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo n=29 Participants Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6. PCSS Total Score - 3 Weeks	9.41 units on a scale Standard Deviation 12.62	7.03 units on a scale Standard Deviation 16.96
Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6. PCSS Total score - 6 Weeks	7.86 units on a scale Standard Deviation 14.5	14.63 units on a scale Standard Deviation 23.41

SECONDARY outcome

Timeframe: From baseline to 3 weeks and from baseline to 6 weeks

This measure indicates the mean difference in total cognitive symptom scores between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 weeks scores. The total cognitive symptom scored is a sum of 7 symptom scores from the PCSS; feeling slowed down, feeling like "in a fog", "don't feel right", difficulty concentrating, difficulty remembering, fatigue or low energy, and confusion. The severity of these symptoms are scored 0-6, 0=none, 6=severe. The range for the total cognitive symptom score is 0-42, a lower score represents a better outcome.

Outcome measures

Outcome measures
Measure	MedX Health Console Model 1100 n=22 Participants The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	MedX Health Console Model 1100-placebo n=29 Participants Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6 Cognitive Sx Score - 3 Weeks	3.95 units on a scale Standard Deviation 6.56	1.31 units on a scale Standard Deviation 6.96
Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6 Cognitive Sx Score - 6 Weeks	4.00 units on a scale Standard Deviation 6.59	5.00 units on a scale Standard Deviation 8.95

Adverse Events

MedX Health Console Model 1100

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MedX Health Console Model 1100-placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MedX Health Console Model 1100 n=23 participants at risk The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. All treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar	MedX Health Console Model 1100-placebo n=30 participants at risk Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. All placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r
Skin and subcutaneous tissue disorders Discomfort	4.3% 1/23 • Number of events 1	0.00% 0/30

Additional Information

Dr. William Meehan

Boston Children's Hospital

Phone: 781-216-1328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place