Effects of Bright Light Therapy in Mild Traumatic Brain Injury

NCT01747811 | Completed Results

• 1 other identifier: 2010-P-001570/1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; Post-Concussion Symptoms; Sleep Problems

Keywords

Mild traumatic brain injury; Concussion; Sleep problems; brain imaging; functional magnetic resonance imaging (FMRI)

Outcome Measures

Primary Outcomes (1)

• Performance on Multiple Sleep Latency Test (MSLT)

  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.

  Change from baseline performance at 6 weeks (post-treatment)

Secondary Outcomes (4)

• Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task

  Change from baseline performance at 6 weeks (post-treatment)

• Score on Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline at 6 weeks (post-treatment)

• Actigraphy-measured Sleep Quality

  Change from baseline at 6 weeks (post-treatment)

• Performance on Neuropsychological Assessment

  Change from baseline at 6 weeks (post-treatment)

Other Outcomes (1)

• Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks

  Change from baseline at 6 weeks (post-treatment)

Study Arms (2)

wavelength-1 bright light

EXPERIMENTAL

30 minutes daily light exposure for 6 weeks

Device: wavelength-1 bright light

wavelength-2 bright light

PLACEBO COMPARATOR

30 minutes daily light exposure for 6 weeks

Device: wavelength-2 bright light

Interventions

wavelength-1 bright light DEVICE

6 weeks of daily light exposure, 30 minutes per morning

Also known as: Philips goLITE energy light

wavelength-1 bright light

wavelength-2 bright light DEVICE

6 weeks of daily light exposure, 30 minutes per morning

Also known as: Philips goLITE energy light

wavelength-2 bright light

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• U.S. Army Medical Research Acquisition Activity: collaborator

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Bajaj S, Raikes AC, Razi A, Miller MA, Killgore WD. Blue-Light Therapy Strengthens Resting-State Effective Connectivity within Default-Mode Network after Mild TBI. J Cent Nerv Syst Dis. 2021 May 19;13:11795735211015076. doi: 10.1177/11795735211015076. eCollection 2021.

  PMID: 34104033 DERIVED

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Parasomnias

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Sleep Wake Disorders; Mental Disorders

Results Point of Contact

• Title: William Killgore
• Organization: University of Arizona

killgore@psychiatry.arizona.edu

520-621-0605

Study Officials

• William D Killgore, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 1, 2017
• Results First Posted: August 15, 2016

Record last verified: 2017-05

Locations

US (1)