Traumatic Brain Injury, Posttraumatic Stress Disorder
Conditions
Keywords
Traumatic Brain Injury, Light Emitting Diodes, Cognition, Neuromodulation, PTSD, Neurorehabilitation, Veterans, Sleep
Brief summary
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
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Functioning_Attention/Executive | Eight Weeks | Stroop Test (Color-Word test; Delis, Kaplan & Kramer, 2001) |
| Cognitive Functioning_Learning/Memory | Eight weeks | California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Status/Mood | Eight weeks | Beck Depression inventory (BDI; Beck, 2006) |
| Neuropsychiatric status/PTSD | Eight weeks | PTSD Checklist - Military Version (PCL-M) |
| Neuropsychiatric status/Sleep | Eight weeks | Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) |
Countries
United States
Outcome results
None listed