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Trial record 86 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Brain Injuries, Traumatic

Effects of Bright Light Therapy in Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01747811
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : August 15, 2016
Last Update Posted : June 1, 2017
U.S. Army Medical Research Acquisition Activity
Information provided by (Responsible Party):
William D. Killgore, University of Arizona

Brief Summary:

Mild traumatic brain injuries (mTBI) or "concussions" are an increasingly prevalent injury in our society. Patients with post-concussion syndrome have been shown to have deficits on tests of short term memory, divided attention, multi-tasking, information processing speed, and reaction time, as well as alteration in mood and emotional functioning. Many patients have other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer outcome, while resolution of the sleep disturbance is associated with improvement in cognitive functioning.

Despite recent evidence of the correlation between sleep quality and recovery from traumatic brain injury, and the well-established role of sleep in neural plasticity and neurogenesis, there have been virtually no direct studies of the causal effects of sleep on recovery following mTBI. However, it is quite likely that sleep plays a critical role in recovery following brain injury.

A particularly promising non-pharmacologic approach that shows potential in improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright light therapy. For the proposed investigation, we hypothesize that bright light therapy may be helpful in improving the sleep of patients with a recent history of mTBI and may also have other mood elevating effects, both of which should promote positive treatment outcome in these individuals. Bright light therapy may increase the likelihood that they will recover more quickly, benefit more extensively from other forms of therapy, and build emotional and cognitive resilience.

Condition or disease Intervention/treatment Phase
Concussion, Mild Post-Concussion Symptoms Sleep Problems Device: wavelength-1 bright light Device: wavelength-2 bright light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Bright Light Therapy of Sleep, Cognition, Brain Function, and Neurochemistry in Mild Traumatic Brain Injury
Study Start Date : December 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: wavelength-1 bright light
30 minutes daily light exposure for 6 weeks
Device: wavelength-1 bright light
6 weeks of daily light exposure, 30 minutes per morning
Other Name: Philips goLITE energy light

Placebo Comparator: wavelength-2 bright light
30 minutes daily light exposure for 6 weeks
Device: wavelength-2 bright light
6 weeks of daily light exposure, 30 minutes per morning
Other Name: Philips goLITE energy light

Primary Outcome Measures :
  1. Performance on Multiple Sleep Latency Test (MSLT) [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.

Secondary Outcome Measures :
  1. Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    Change from baseline in left prefrontal cortical response during a multi source interference task at six weeks. Methods utilized to assess activity in the left prefrontal cortex/inferior frontal operculum included a regions of interest analysis.

  2. Score on Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline at 6 weeks (post-treatment) ]
    The Pittsburgh Sleep Quality Index is a self report measure of sleep quality. The overall score takes into account many different facets of sleep, such as sleep quality, sleep latency, sleep duration, sleep disturbances, etc. The scores range from 0-21, and any score that is equal to or greater than 5 is indicative of poor sleep quality.

  3. Actigraphy-measured Sleep Quality [ Time Frame: Change from baseline at 6 weeks (post-treatment) ]
    Actigraphy is an objective measure that determines sleep vs. wake. It is a watch with an accelerometer worn on the wrist. Sleep quality is determined by the amount of time in bed divided by the amount of time sleeping (in minutes).

  4. Performance on Neuropsychological Assessment [ Time Frame: Change from baseline at 6 weeks (post-treatment) ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological assessment that measures different facets of memory including the following: immediate memory, visuospatial/constructional, language, attention, and delayed memory. This is given to all participants on both pre and post treatment visits. The total range for this scale is 40-160. Lower values represent a worse outcome, and higher values represent an improved outcome.

Other Outcome Measures:
  1. Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks [ Time Frame: Change from baseline at 6 weeks (post-treatment) ]
    The Beck Depression Inventory (BDI-II) is a self report scale utilized for measuring the severity of depression. Scores can range from 0-63 (0 meaning minimal depressive symptoms, and 63 being severe depressive symptoms). Participants are given this on baseline and post treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age range between 18 and 50.
  • Subjects must be right handed.
  • The primary language of the subjects must be English.
  • Subjects have experienced a "concussion" or mTBI within the preceding 18 months, but no sooner that 4 weeks prior to their screening. The occurrence of a concussion or mTBI must be documented by a medical report or other professional witness documentation.
  • If documented, Glasgow Coma Scale in the range of 13-15 following the injury.
  • Subjects must have complaints of sleep difficulties that emerged or worsened following the most recent head injury.
  • At least half of subjects must have evidence of sleep onset insomnia or delayed sleep phase disorder.

Exclusion Criteria:

  • Any other history of neurological illness, current Diagnostic and Statistical Manual (DSM-IV) Axis I disorder, lifetime history of psychotic disorder, or head injury with loss of consciousness > 30 minutes
  • Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV, brain tumor, etc.)
  • Mixed or left-handedness
  • Abnormal visual acuity that is not corrected by contact lenses
  • Contraindicated conditions noted by the manufacture of the light device such as the use of photosynthesizing medications, history of cataract surgery, and pre-existing eye conditions.
  • Metal within the body, claustrophobia, or other contraindications for neuroimaging
  • Less than 9th grade education
  • Excess current alcohol use (more than 2 instances of intake of 5+ drinks (men) when or 4+ drinks (women) when drinking in the past two months, and/or on average drinking > 2 drinks per day (men); > 1 drinks per day (women) during the past two months
  • History of alcoholism or substance use disorder
  • Significant use of illicit drugs
  • History of marijuana use within the past 6 weeks, use of marijuana before the age of 16, and/or use of > 20 marijuana cigarettes throughout the participant's lifetime.
  • Subjects who engage in shift-work, night work, or who have substantially desynchronized work-sleep schedules (i.e., sleeping later than 10:00 a.m. more than once a week) will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01747811

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United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
U.S. Army Medical Research Acquisition Activity
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Principal Investigator: William D Killgore, PhD University of Arizona

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Responsible Party: William D. Killgore, Professor, University of Arizona Identifier: NCT01747811     History of Changes
Other Study ID Numbers: 2010-P-001570/1
First Posted: December 12, 2012    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by William D. Killgore, University of Arizona:
Mild traumatic brain injury
Sleep problems
brain imaging
functional magnetic resonance imaging (FMRI)
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Sleep Wake Disorders
Post-Concussion Syndrome
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms