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Trial record 7 of 213 for:    Open Studies | "Fatigue"
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Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy

This study is currently recruiting participants.
Verified November 2012 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Joshua Cantor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01725750
First received: November 7, 2012
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Fatigue
 Device: Bright White Light (BWL)
Device: Dim Red Light (DRL)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Post-TBI Fatigue With Light Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Multidimensional Assessment of Fatigue (MAF) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Multidimensional Assessment of Fatigue (MAF) [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    See above

  • Multidimensional Assessment of Fatigue (MAF) [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    See above


Secondary Outcome Measures:
  • TBI-QOL Fatigue [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The TBI-QOL Fatigue measure will be used. TBI-QOL measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders.

  • TBI-QOL Fatigue [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    See above

  • TBI-QOL Fatigue [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    See above

  • Neuro-QOL Depression and Sleep [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The Neuro-QOL Depression and Sleep measures will be used

  • Neuro-QOL Depression and Sleep [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    The Neuro-QOL Depression and Sleep measures will be used

  • Neuro-QOL Depression and Sleep [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    The Neuro-QOL Depression and Sleep measures will be used

  • Epworth Sleepiness Scale (ESS) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset.

  • Epworth Sleepiness Scale (ESS) [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    See above

  • Epworth Sleepiness Scale (ESS) [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    See above

  • CNS Vital Signs TBI Rehab Toolbox [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The CNS Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment.

  • CNS Vital Signs TBI Rehab Toolbox [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    See above

  • CNS Vital Signs TBI Rehab Toolbox [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    See above

  • Cognitive Failures Questionnaire [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception).

  • Cognitive Failures Questionnaire [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    See above

  • Cognitive Failures Questionnaire [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    See above

  • Neuro-QOL Anxiety [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The Neuro-QOL Anxiety measure will be used

  • Neuro-QOL Anxiety [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    The Neuro-QOL Anxiety measure will be used

  • Neuro-QOL Anxiety [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    The Neuro-QOL Anxiety measure will be used

  • Actiwatch Spectrum [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.

  • Actiwatch Spectrum [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    See above

  • Satisfaction with Life Scale [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Satisfaction with Life Scale, a 5-item measure of global satisfaction with life.

  • Satisfaction with Life Scale [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    Satisfaction with Life Scale, a 5-item measure of global satisfaction with life.

  • Satisfaction with Life Scale [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    Satisfaction with Life Scale, a 5-item measure of global satisfaction with life.

  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    An adapted version of the Treatment Satisfaction Questionnaire for Medication. This is a validated, psychometrically sound measure of general treatment satisfaction.

  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    See above

  • Credibility/Expectancy Questionnaire [ Time Frame: at 4 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
    Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire, used in clinical outcome studies

  • Credibility/Expectancy Questionnaire [ Time Frame: one month post treatment ] [ Designated as safety issue: No ]
    Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire, used in clinical outcome studies


Estimated Enrollment: 95
Study Start Date: November 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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 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.
Other Name: Litebook - Bright White Light
Active Comparator: 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.
 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 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.
Other Name: Litebook - Dim Red Light

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented TBI of any severity
  • At least 12 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725750

Contacts
Contact: Joshua Cantor, PhD 212-241-8850 joshua.cantor@mountsinai.org

Locations
United States, New York
The Brain Injury Research Center at Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Joshua Cantor, PhD     212-241-8850     joshua.cantor@mountsinai.org    
Contact: Wayne Gordon, PhD     212-659-9372     Wayne.Gordon@mountsinai.org    
Principal Investigator: Joshua Cantor, PhD            
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Joshua Cantor, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Joshua Cantor, Associate Professor, Co-Director BIRC, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01725750     History of Changes
Other Study ID Numbers: GCO 12-1256, HSM 12-00759, H133A120084
Study First Received: November 7, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Fatigue
Post-TBI Fatigue
Traumatic Brain Injury
TBI
PTBIF
Depressed Mood
 Excessive Daytime Sleepiness
Circadian Rhythm
Anxiety
Cognitive Dysfunction
Intervention
Treatment

Additional relevant MeSH terms:
Fatigue
Brain Injuries
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013