Trial Outcomes & Findings for Effects of LEDs on Memory in TBI Patients (NCT NCT01598532)

Results Overview

Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Baseline and 1-Week, 1-month and 2-months after final LED Treatment

Results posted on

2016-09-30

Participant Flow

Recruitment for the study began in April 2010. Potential subjects were recruited through several different methods - Spaulding Rehabilitation Hospital outpatient clinic, advertisements in local area newspapers, Brain Injury Association of MA and other area organizations that provide services to TBI survivors, flyers, on-line and social media.

22 study subjects signed the consent but only 11 completed the study. The 11 that did not completed the study either did not meet the inclusion criteria at Screening or were lost to follow-up after they screened for the study.

Participant milestones

Participant milestones
Measure	Transcranial LED Treatment Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
Overall Study STARTED	22
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcranial LED Treatment Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
Overall Study Lost to Follow-up	3
Overall Study Did not meet inclusion criteria	8

Baseline Characteristics

Effects of LEDs on Memory in TBI Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial LED Treatment n=11 Participants All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month \& 2 months following the last LED treatment. The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free \& Cued Recall, Long Delay Free \& Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), \& 5) Digit Span, Forwards \& Backwards. The following tests were not analyzed due to collinearity with other measures (r \> .8): Short Delay Free \& Cued Recall, Long Delay Cued Recall, \& Delis-Kaplan Executive Function (D-KEF) -Trails Test.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Time Post TBI	3.12 years post TBI STANDARD_DEVIATION 2.50 • n=5 Participants
Years of Education	15.72 Years of Education STANDARD_DEVIATION 2.97 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1-Week, 1-month and 2-months after final LED Treatment

Population: All participants enrolled in the Transcranial LED Treatment Group

Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial LED Treatment n=11 Participants MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Stroop Test for Executive Function - Trial 3 - Inhibition Pre-test data	-0.7407 # of SD units Standard Deviation 1.1561
Stroop Test for Executive Function - Trial 3 - Inhibition 1 Week post test data	.036 # of SD units Standard Deviation .7407
Stroop Test for Executive Function - Trial 3 - Inhibition 1 Month post test data	.718 # of SD units Standard Deviation 1.0133
Stroop Test for Executive Function - Trial 3 - Inhibition 2 Months post test data	.815 # of SD units Standard Deviation .9499

PRIMARY outcome

Timeframe: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment

Population: All participants enrolled in Transcranial LED Treatment Group

Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial LED Treatment n=11 Participants MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Stroop Test for Executive Function - Trial 4 Inhibition Switching Pre-test data	-1.050 # of SD Units Standard Deviation 1.1058
Stroop Test for Executive Function - Trial 4 Inhibition Switching 1 week post test data	-0.100 # of SD Units Standard Deviation 1.3994
Stroop Test for Executive Function - Trial 4 Inhibition Switching 1 Month post test data	.553 # of SD Units Standard Deviation 1.167
Stroop Test for Executive Function - Trial 4 Inhibition Switching 2 Month post test data	.854 # of SD Units Standard Deviation 1.3544

PRIMARY outcome

Timeframe: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment

Population: All participants enrolled in Real Intervention Group

California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial LED Treatment n=11 Participants MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 Pre-test Data	-.409 # of SD Units Standard Deviation .7687
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 1 Week post test data	.364 # of SD Units Standard Deviation .809
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 1 Month post test data	.630 # of SD Units Standard Deviation .7015
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 2 Month post test data	.780 # of SD Units Standard Deviation .9724

PRIMARY outcome

Timeframe: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

Population: All participants enrolled in Transcranial LED Treatment Group

California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial LED Treatment n=11 Participants MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall Pre-test data	-1.136 # of SD Units Standard Deviation 1.4334
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall 1 Week post test data	-0.136 # of SD Units Standard Deviation 1.1851
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall 1 Month post test data	-0.200 # of SD Units Standard Deviation 1.249
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall 2 Month post test data	0.050 # of SD Units Standard Deviation 1.15

PRIMARY outcome

Timeframe: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

Population: All participants enrolled in the Transcranial LED Treatment Group

Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial LED Treatment n=11 Participants MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Controlled Oral Word Association Test (FAS) Pre-test data	-.318 # of SD units Standard Deviation 1.54
Controlled Oral Word Association Test (FAS) 1 Week post test data	.136 # of SD units Standard Deviation 1.45
Controlled Oral Word Association Test (FAS) 1 Month post test data	.114 # of SD units Standard Deviation 1.58
Controlled Oral Word Association Test (FAS) 2 Month post test data	.285 # of SD units Standard Deviation 1.38

PRIMARY outcome

Timeframe: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

Population: All participants enrolled in the Transcranial LED Treatment Group

Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial LED Treatment n=11 Participants MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Digit Span, Forwards and Backwards Pre-test data	-.182 # of SD units Standard Deviation 1.45
Digit Span, Forwards and Backwards 1 Week post test data	.318 # of SD units Standard Deviation 1.31
Digit Span, Forwards and Backwards 1 Month post test data	.444 # of SD units Standard Deviation 1.42
Digit Span, Forwards and Backwards 2 Month post test data	.650 # of SD units Standard Deviation 1.52

Adverse Events

Transcranial LED Treatment

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

Ross D. Zafonte, DO

Spaulding Rehabilitation Hospital

Phone: 617-952-5227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place