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

NCT01725750 | Completed Results FDA Device

• 3 other identifiers: GCO 12-1256HSM 12-00759H133A120084
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Multidimensional Assessment of Fatigue (MAF)

  Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.

  baseline, 4 weeks, 8 weeks

Secondary Outcomes (12)

• TBI-QOL Fatigue

  baseline, 4 weeks, 8 weeks

• Neuro-QOL Depression and Sleep

  baseline, 4 weeks, 8 weeks

• Epworth Sleepiness Scale (ESS)

  baseline, 4 weeks, 8 weeks

• CNS Vital Signs TBI Rehab Toolbox

  baseline, 4 weeks, 8 weeks

• Cognitive Failures Questionnaire

  baseline, 4 weeks, 8 weeks

Study Arms (2)

Bright White Light (BWL)

EXPERIMENTAL

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.

Device: Bright White Light (BWL)

Dim Red Light (DRL)

ACTIVE COMPARATOR

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.

Device: Dim Red Light (DRL)

Interventions

Bright White Light (BWL) DEVICE

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 45º 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.

Also known as: Litebook - Bright White Light

Bright White Light (BWL)

Dim Red Light (DRL) DEVICE

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 45º 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.

Also known as: Litebook - Dim Red Light

Dim Red Light (DRL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Fatigue; Consciousness Disorders; Disorders of Excessive Somnolence; Anxiety Disorders; Cognitive Dysfunction

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Jacob Greisman
• Organization: Icahn School of Medicine at Mount Sinai

Jacob.greisman@mountsinai.org

212-241-4886

Study Officials

• Wayne Gordon, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Kirsten Dams-O'Connor, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 7, 2019
• Results First Posted: September 11, 2018

Record last verified: 2019-07

Locations

US (1)