AzTrials
AzTrials

Traumatic Brain InjuryNCT01725750

Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy

A study testing Bright White Light (BWL) and Dim Red Light (DRL) in people with Traumatic Brain Injury and Fatigue, run by Icahn School of Medicine at Mount Sinai 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
Search all trials

Trial summary

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury, Fatigue
What is being tested?
Bright White Light (BWL) and Dim Red Light (DRL)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
Nov 2012to Jun 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented TBI of any severity
  • At least 6 months post injury
  • Presence of clinically significant fatigue, operationalized as a score of 22 or more on the Multidimensional Assessment of Fatigue
  • Age 18 or older
  • English speaking

Who cannot join

  • Neurological disease other than TBI
  • Pregnancy (because of pregnancy fatigue)
  • Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure, cirrhosis or cancer treatment in the past year
  • Current major depressive episode or substance abuse
  • Diagnosed sleep disorder or high risk for sleep apnea
  • History of bipolar disorder or manic or hypomanic episodes
Show all 9Show fewer
  • Current chronic, severe headaches
  • Sensitivity to bright light
  • History of retinal damage or disease

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Treatment of Post-TBI Fatigue With Light Therapy

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.

Read the detailed description

To determine the efficacy of bright white light exposure compared to dim red light exposure in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be performed. Outcome assessment will be blinded. Participants will complete a baseline battery (T1) including 72 hours of actigraphy. Participants will then be randomized to either the Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute light treatments, the baseline battery will be re-administered (T2) along with 3 more days of Actigraphy. A follow-up assessment involving the same measures will be administered 1 month-post cessation of light therapy (T3). Participant treatment allocations will be masked for research team members conducting outcome measures. Secondary outcome measures will be administered to explore the effects of light therapy on mood, daytime sleepiness, sleep quality, circadian rhythms, anxiety, cognition and life satisfaction.

Being tested
Bright White Light (BWL), Dim Red Light (DRL)
Keywords
Traumatic Brain Injury, TBI, Fatigue, Post-TBI Fatigue, PTBIF, Depressed Mood, Excessive Daytime Sleepiness, Circadian Rhythm, Anxiety, Cognitive Dysfunction, Intervention, Treatment
Medical subject headings
Brain Injuries, Traumatic, Fatigue, Consciousness Disorders, Disorders of Excessive Somnolence, Anxiety Disorders, Cognitive Dysfunction

What participants receive

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

  • Bright White Light (BWL)Device

    Also called Litebook - Bright White Light

    Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.

  • Dim Red Light (DRL)Device

    Also called Litebook - Dim Red Light

    A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.

Study groups in NCT01725750
Study groupRoleWhat they receive
Bright White Light (BWL)ExperimentalParticipants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.
Receives: Device: Bright White Light (BWL)
Dim Red Light (DRL)Active comparatorParticipants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Receives: Device: Dim Red Light (DRL)

What is being measured

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

  1. Multidimensional Assessment of Fatigue (MAF)

    Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.

    Measured: baseline, 4 weeks, 8 weeks

Secondary outcomes (12)
  1. TBI-QOL Fatigue

    The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.

    Measured: baseline, 4 weeks, 8 weeks

  2. Neuro-QOL Depression and Sleep

    The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.

    Measured: baseline, 4 weeks, 8 weeks

  3. Epworth Sleepiness Scale (ESS)

    The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.

    Measured: baseline, 4 weeks, 8 weeks

  4. CNS Vital Signs TBI Rehab Toolbox

    The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.

    Measured: baseline, 4 weeks, 8 weeks

  5. Cognitive Failures Questionnaire

    The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.

    Measured: baseline, 4 weeks, 8 weeks

  6. Neuro-QOL Anxiety

    The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.

    Measured: baseline, 4 weeks, 8 weeks

  7. Actiwatch Spectrum - Acrophase

    Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.

    Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.

    Measured: 4 weeks post treatment

  8. Actiwatch Spectrum - Mesor

    Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.

    Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.

    Measured: 4 weeks post treatment

  9. Actiwatch Spectrum - F Statistic

    Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.

    F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.

    Measured: 4 weeks post treatment

  10. Satisfaction With Life Scale

    Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.

    Measured: baseline, 4 weeks, 8 weeks

  11. Treatment Satisfaction Questionnaire for Medication

    An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.

    Measured: at 4 weeks (end-of-treatment)

  12. Credibility/Expectancy Questionnaire

    Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.

    Measured: at 4 weeks (end-of-treatment)

Timeline

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

  1. First posted14 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJun 2017
  4. Study completionJun 2017

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
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01725750
Sponsor's protocol ID
GCO 12-1256
Other IDs
HSM 12-00759, H133A120084
Status last verified
Jul 2019
First submitted
7 Nov 2012
Last updated
7 Aug 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Bright White Light (BWL) and Dim Red Light (DRL) in people with Traumatic Brain Injury and Fatigue, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 9 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 7 Aug 2019. 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. 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 11 Sep 2018). 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?

Multidimensional Assessment of Fatigue (MAF) (time frame: baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Aug 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in