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Concussion, MildNCT01747811

Effects of Bright Light Therapy in Mild Traumatic Brain Injury

A study testing wavelength-1 bright light and wavelength-2 bright light in people with Concussion, Mild and Post-Concussion Symptoms, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
wavelength-1 bright light and wavelength-2 bright light
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
Dec 2010to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona Medical Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Effects of Bright Light Therapy of Sleep, Cognition, Brain Function, and Neurochemistry in Mild Traumatic Brain Injury

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.

Being tested
wavelength-1 bright light, wavelength-2 bright light
Keywords
Mild traumatic brain injury, Concussion, Sleep problems, brain imaging, functional magnetic resonance imaging (FMRI)
Medical subject headings
Brain Concussion, Post-Concussion Syndrome, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wavelength-1 bright lightDevice

    Also called Philips goLITE energy light

    6 weeks of daily light exposure, 30 minutes per morning

  • wavelength-2 bright lightDevice

    Also called Philips goLITE energy light

    6 weeks of daily light exposure, 30 minutes per morning

Study groups in NCT01747811
Study groupRoleWhat they receive
wavelength-1 bright lightExperimental30 minutes daily light exposure for 6 weeks
Receives: Device: wavelength-1 bright light
wavelength-2 bright lightPlacebo comparator30 minutes daily light exposure for 6 weeks
Receives: Device: wavelength-2 bright light

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. 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.

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

  2. 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.

    Measured: Change from baseline at 6 weeks (post-treatment)

  3. 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).

    Measured: Change from baseline at 6 weeks (post-treatment)

  4. 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.

    Measured: Change from baseline at 6 weeks (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01747811
Sponsor's protocol ID
2010-P-001570/1
Status last verified
May 2017
First submitted
6 Dec 2012
Last updated
1 Jun 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 34104033

Questions about this trial

What is this clinical trial studying?

A study testing wavelength-1 bright light and wavelength-2 bright light in people with Concussion, Mild and Post-Concussion Symptoms, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance on Multiple Sleep Latency Test (MSLT) (time frame: Change from baseline performance at 6 weeks (post-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01747811, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

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