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

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Fatigue

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Bright White Light (BWL)Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45┬║ of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.

Device:Dim Red Light (DRL)A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45┬║ of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Bright White Light (BWL)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.

Dim Red Light (DRL)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.

Study Status

Completed

Start Date: November 2012

Completed Date: June 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Multidimensional Assessment of Fatigue (MAF)

Secondary Outcome: TBI-QOL Fatigue

Study sponsors, principal investigator, and references

Principal Investigator: Wayne Gordon, PhD

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01725750

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