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Effects of Bright Light Therapy in Mild Traumatic Brain Injury

Primary Purpose

Concussion, Mild, Post-Concussion Symptoms, Sleep Problems

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
wavelength-1 bright light
wavelength-2 bright light
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild focused on measuring Mild traumatic brain injury, Concussion, Sleep problems, brain imaging, functional magnetic resonance imaging (FMRI)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arizona Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

wavelength-1 bright light

wavelength-2 bright light

Arm Description

30 minutes daily light exposure for 6 weeks

30 minutes daily light exposure for 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task
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.
Score on Pittsburgh Sleep Quality Index (PSQI)
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.
Actigraphy-measured Sleep Quality
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).
Performance on Neuropsychological Assessment
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.

Full Information

First Posted
December 6, 2012
Last Updated
May 1, 2017
Sponsor
University of Arizona
Collaborators
U.S. Army Medical Research Acquisition Activity
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1. Study Identification

Unique Protocol Identification Number
NCT01747811
Brief Title
Effects of Bright Light Therapy in Mild Traumatic Brain Injury
Official Title
Effects of Bright Light Therapy of Sleep, Cognition, Brain Function, and Neurochemistry in Mild Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
U.S. Army Medical Research Acquisition Activity

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Post-Concussion Symptoms, Sleep Problems
Keywords
Mild traumatic brain injury, Concussion, Sleep problems, brain imaging, functional magnetic resonance imaging (FMRI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wavelength-1 bright light
Arm Type
Experimental
Arm Description
30 minutes daily light exposure for 6 weeks
Arm Title
wavelength-2 bright light
Arm Type
Placebo Comparator
Arm Description
30 minutes daily light exposure for 6 weeks
Intervention Type
Device
Intervention Name(s)
wavelength-1 bright light
Other Intervention Name(s)
Philips goLITE energy light
Intervention Description
6 weeks of daily light exposure, 30 minutes per morning
Intervention Type
Device
Intervention Name(s)
wavelength-2 bright light
Other Intervention Name(s)
Philips goLITE energy light
Intervention Description
6 weeks of daily light exposure, 30 minutes per morning
Primary Outcome Measure Information:
Title
Performance on Multiple Sleep Latency Test (MSLT)
Description
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.
Time Frame
Change from baseline performance at 6 weeks (post-treatment)
Secondary Outcome Measure Information:
Title
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task
Description
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.
Time Frame
Change from baseline performance at 6 weeks (post-treatment)
Title
Score on Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Change from baseline at 6 weeks (post-treatment)
Title
Actigraphy-measured Sleep Quality
Description
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).
Time Frame
Change from baseline at 6 weeks (post-treatment)
Title
Performance on Neuropsychological Assessment
Description
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.
Time Frame
Change from baseline at 6 weeks (post-treatment)
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks
Description
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.
Time Frame
Change from baseline at 6 weeks (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Killgore, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34104033
Citation
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.
Results Reference
derived

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Effects of Bright Light Therapy in Mild Traumatic Brain Injury

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