Clinical trial NCT01725750: Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy
Official title: Treatment of Post-TBI Fatigue With Light Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Fatigue
Keywords: Traumatic Brain Injury
TBI
Fatigue
Post-TBI Fatigue
PTBIF
Depressed Mood
Excessive Daytime Sleepiness
Circadian Rhythm
Anxiety
Cognitive Dysfunction
Intervention
Treatment
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional Assessment of Fatigue (MAF)
timeFrame: baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: TBI-QOL Fatigue
timeFrame: baseline, 4 weeks, 8 weeks
measure: Neuro-QOL Depression and Sleep
timeFrame: baseline, 4 weeks, 8 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: baseline, 4 weeks, 8 weeks
measure: CNS Vital Signs TBI Rehab Toolbox
timeFrame: baseline, 4 weeks, 8 weeks
measure: Cognitive Failures Questionnaire
timeFrame: baseline, 4 weeks, 8 weeks
measure: Neuro-QOL Anxiety
timeFrame: baseline, 4 weeks, 8 weeks
measure: Actiwatch Spectrum - Acrophase
timeFrame: 4 weeks post treatment
measure: Actiwatch Spectrum - Mesor
timeFrame: 4 weeks post treatment
measure: Actiwatch Spectrum - F Statistic
timeFrame: 4 weeks post treatment
measure: Satisfaction With Life Scale
timeFrame: baseline, 4 weeks, 8 weeks
measure: Treatment Satisfaction Questionnaire for Medication
timeFrame: at 4 weeks (end-of-treatment)
measure: Credibility/Expectancy Questionnaire
timeFrame: at 4 weeks (end-of-treatment)
Other outcomes:
Locations:
city: New York
country: United States
facility: The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Wayne Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Kirsten Dams-O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References: