Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy



Status:Completed
Conditions:Other Indications, Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:November 2012
End Date:June 2017

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Treatment of Post-TBI Fatigue With Light Therapy

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing
Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month
follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white
light treatment will report significant reductions in fatigue compared to individuals
receiving dim red light treatment for the same duration of time, and that these treatment
effects will be maintained one month after treatment completion.

To determine the efficacy of bright white light exposure compared to dim red light exposure
in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be
performed. Outcome assessment will be blinded. Participants will complete a baseline battery
(T1) including 72 hours of actigraphy. Participants will then be randomized to either the
Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute
light treatments, the baseline battery will be re-administered (T2) along with 3 more days of
Actigraphy. A follow-up assessment involving the same measures will be administered 1
month-post cessation of light therapy (T3). Participant treatment allocations will be masked
for research team members conducting outcome measures. Secondary outcome measures will be
administered to explore the effects of light therapy on mood, daytime sleepiness, sleep
quality, circadian rhythms, anxiety, cognition and life satisfaction.

Inclusion Criteria:

- Documented TBI of any severity

- At least 6 months post injury

- Presence of clinically significant fatigue, operationalized as a score of 22 or more
on the Multidimensional Assessment of Fatigue

- Age 18 or older

- English speaking

Exclusion Criteria:

- Neurological disease other than TBI

- Pregnancy (because of pregnancy fatigue)

- Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure,
cirrhosis or cancer treatment in the past year

- Current major depressive episode or substance abuse

- Diagnosed sleep disorder or high risk for sleep apnea

- History of bipolar disorder or manic or hypomanic episodes

- Current chronic, severe headaches

- Sensitivity to bright light

- History of retinal damage or disease
We found this trial at
1
site
New York, New York 10029
Principal Investigator: Wayne Gordon, PhD
Phone: 212-659-9372
?
mi
from
New York, NY
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