Effects of Bright Light Therapy in Mild Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
William Killgore, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01747811
First received: December 6, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 Intervention
Concussion, Mild
Post-Concussion Symptoms
Sleep Problems
Device: wavelength-1 bright light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Bright Light Therapy of Sleep, Cognition, Brain Function, and Neurochemistry in Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Performance on Multiple Sleep Latency Test [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ] [ Designated as safety issue: No ]
    Objective measure of sleepiness


Secondary Outcome Measures:
  • Neural activation during fMRI executive function task [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ] [ Designated as safety issue: No ]
  • Score on Pittsburgh Sleep Quality Index [ Time Frame: Change from baseline at 6 weeks (post-treatment) ] [ Designated as safety issue: No ]
    Subjective measure of sleepiness

  • Actigraphy-measured sleep quality [ Time Frame: Change from baseline at 6 weeks (post-treatment) and 12 weeks (follow-up) ] [ Designated as safety issue: No ]
  • Performance on neuropsychological assessment [ Time Frame: Change from baseline at 6 weeks (post-treatment) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Score on mood inventory [ Time Frame: Change from baseline at 6 weeks (post-treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747811

Contacts
Contact: Maia Kipman 617-855-2239 mkipman@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Maia Kipman    617-855-2239    mkipman@mclean.harvard.edu   
Principal Investigator: William D Killgore, PhD         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: William D Killgore, PhD Mclean Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: William Killgore, Associate Professor, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01747811     History of Changes
Other Study ID Numbers: W81XWH-11-1-0056
Study First Received: December 6, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Mild traumatic brain injury
Concussion
Sleep problems
brain imaging
fMRI

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Post-Concussion Syndrome
Dyssomnias
Sleep Disorders
Parasomnias
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014