LED Treatment to Improve Cognition and Promote Recovery in TBI

Study Overview
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Brief Summary
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This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

Detailed Description
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The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.

Official Title
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Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI

Conditions
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Traumatic Brain Injury, Posttraumatic Stress Disorder

Intervention / Treatment
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* Other: LED
* Other: sham LED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure Meets criteria for mild TBI LOC of 30 min or less Age: 21-55 Primary language is English Exclusion Criteria: Evidence of penetrating head injury History of previous neurological diagnosis History of previous psychotic disorder prior to TBI Hearing or vision impairment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active LED<br>Active LED Treatment | Other: LED<br>* Low Level Light Therapy<br>|
| Sham Comparator: Sham LED<br>Inactive (sham) LED Treatment | Other: sham LED<br>* Inactive (sham) LED treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Functioning_Attention/Executive | Stroop Test (Color-Word test; Delis, Kaplan & Kramer, 2001) | Eight Weeks | 
| Cognitive Functioning_Learning/Memory | California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000) | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Status/Mood | Beck Depression inventory (BDI; Beck, 2006) | Eight weeks | 
| Neuropsychiatric status/PTSD | PTSD Checklist - Military Version (PCL-M) | Eight weeks | 
| Neuropsychiatric status/Sleep | Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Light Emitting Diodes, Cognition, Neuromodulation, PTSD, Neurorehabilitation, Veterans, Sleep