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.
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
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.
- Conditions
- Traumatic Brain Injury, Fatigue
- 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 group | Role | What they receive |
|---|---|---|
| Bright White Light (BWL) | Experimental | Participants 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 comparator | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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)
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.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Dams-O'Connor, Icahn School of Medicine at Mount Sinai
- Investigators
- Wayne Gordon, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiKirsten Dams-O'Connor, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-TBI Fatigue With Light Therapy
- ClinicalTrials.gov ID
- NCT01725750
- Acronym / sponsor ID
- GCO 12-1256
- Conditions
- Traumatic Brain Injury, Fatigue
- Keywords
- Traumatic Brain Injury, TBI, Fatigue, Post-TBI Fatigue, PTBIF, Depressed Mood, Excessive Daytime Sleepiness, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Posted 11 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright White Light (BWL) | Experimental | Device: Bright White Light (BWL)Participants 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. |
| Dim Red Light (DRL) | Active comparator | Device: Dim Red Light (DRL)Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright White Light (BWL)Also: Litebook - Bright White LightParticipants 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. | Device | Bright White Light (BWL) |
| Dim Red Light (DRL)Also: Litebook - Dim Red LightA 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. | Device | Dim Red Light (DRL) |
Primary outcome
Multidimensional Assessment of Fatigue (MAF)
Time frame: baseline, 4 weeks, 8 weeks
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.
12 secondary outcomes
TBI-QOL Fatigue
Time frame: baseline, 4 weeks, 8 weeks
Neuro-QOL Depression and Sleep
Time frame: baseline, 4 weeks, 8 weeks
Epworth Sleepiness Scale (ESS)
Time frame: baseline, 4 weeks, 8 weeks
CNS Vital Signs TBI Rehab Toolbox
Time frame: baseline, 4 weeks, 8 weeks
Cognitive Failures Questionnaire
Time frame: baseline, 4 weeks, 8 weeks
Neuro-QOL Anxiety
Time frame: baseline, 4 weeks, 8 weeks
Actiwatch Spectrum - Acrophase
Time frame: 4 weeks post treatment
Actiwatch Spectrum - Mesor
Time frame: 4 weeks post treatment
Actiwatch Spectrum - F Statistic
Time frame: 4 weeks post treatment
Satisfaction With Life Scale
Time frame: baseline, 4 weeks, 8 weeks
Treatment Satisfaction Questionnaire for Medication
Time frame: at 4 weeks (end-of-treatment)
Credibility/Expectancy Questionnaire
Time frame: at 4 weeks (end-of-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Gordon, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Kirsten Dams-O'Connor, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
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.