Effects of LEDs on Memory in TBI Patients

Study Overview
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Brief Summary
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The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.

Detailed Description
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This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury. Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.

Official Title
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Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: MedX Health Phototherapy (light therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, Ages 18-65 sustained a mild traumatic brain injury(mTBI) at least 6 months ago mTBI is defined as < 30 minutes loss of consciousness and <30 minutes, post trauma amnesia since the injury patient continues having problems with memory and thinking ability Exclusion Criteria: Younger than 18 or older than 65 mTBI occured less than 6 months ago moderate to severe Traumatic Brain Injury (TBI) non-closed head injury presence of craniotomy, craniectomy, or ventriculoperitoneal shunt Non-English speaking subjects - Neuropsychological Tests only in English Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial LED Treatment<br>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. | Device: MedX Health Phototherapy (light therapy)<br>* The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop Test for Executive Function - Trial 3 - Inhibition | 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. | Baseline and 1-Week, 1-month and 2-months after final LED Treatment | 
| Stroop Test for Executive Function - Trial 4 Inhibition Switching | 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. | Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment | 
| California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | 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. | Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment | 
| California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | 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. | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | 
| Controlled Oral Word Association Test (FAS) | 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. | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | 
| Digit Span, Forwards and Backwards | 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. | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild traumatic brain injury, mild TBI, mTBI