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

Mount Sinai Health System

Status: Completed

Conditions: Traumatic Brain Injury; Fatigue

Treatments: Device: Bright White Light (BWL); Device: Dim Red Light (DRL)

Study type: Interventional

Funder types: Other

Identifiers

NCT01725750

GCO 12-1256

HSM 12-00759

H133A120084 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Bright White Light (BWL)

Experimental group

Description:

Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.

Treatment:

Device: Bright White Light (BWL)

Dim Red Light (DRL)

Active Comparator group

Description:

Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.

Treatment:

Device: Dim Red Light (DRL)