Trial Outcomes & Findings for Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy (NCT NCT01725750)
NCT ID: NCT01725750
Last Updated: 2019-08-07
Results Overview
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.
COMPLETED
NA
88 participants
baseline, 4 weeks, 8 weeks
2019-08-07
Participant Flow
From October 2015-January 2017, recruitment materials were sent to previous research and support group participants, and other local TBI centers. Information was also posted online and at consumer conferences. External sites included Centre for Neuro Skills facilities and post-acute rehab centers in Bakersfield and Los Angeles, CA, and Dallas, TX.
Participant milestones
| Measure |
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)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
42
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
10
|
Reasons for withdrawal
| Measure |
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)
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
9
|
Baseline Characteristics
Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy
Baseline characteristics by cohort
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.045 years
STANDARD_DEVIATION 16.335 • n=93 Participants
|
45.182 years
STANDARD_DEVIATION 13.138 • n=4 Participants
|
46.614 years
STANDARD_DEVIATION 14.808 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than one race/Other
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Years of education completed
|
15.841 years
STANDARD_DEVIATION 2.533 • n=93 Participants
|
15.651 years
STANDARD_DEVIATION 2.654 • n=4 Participants
|
15.747 years
STANDARD_DEVIATION 2.580 • n=27 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 weeks, 8 weeksMultidimensional 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Multidimensional Assessment of Fatigue (MAF)
Baseline
|
33.332 score on a scale
Standard Deviation 9.043
|
30.531 score on a scale
Standard Deviation 10.633
|
|
Multidimensional Assessment of Fatigue (MAF)
4 weeks (end of treatment)
|
27.993 score on a scale
Standard Deviation 9.993
|
24.937 score on a scale
Standard Deviation 10.558
|
|
Multidimensional Assessment of Fatigue (MAF)
8 weeks (one month post treatment)
|
28.658 score on a scale
Standard Deviation 12.213
|
25.350 score on a scale
Standard Deviation 10.895
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
TBI-QOL Fatigue
Baseline
|
61.819 T score
Standard Deviation 6.255
|
58.821 T score
Standard Deviation 7.533
|
|
TBI-QOL Fatigue
4 weeks (end of treatment)
|
58.071 T score
Standard Deviation 7.384
|
55.724 T score
Standard Deviation 8.305
|
|
TBI-QOL Fatigue
8 weeks (one month post treatment)
|
58.226 T score
Standard Deviation 8.481
|
57.252 T score
Standard Deviation 9.033
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Neuro-QOL Depression and Sleep
Baseline
|
52.893 T-score
Standard Deviation 8.033
|
82.942 T-score
Standard Deviation 7.570
|
|
Neuro-QOL Depression and Sleep
4 weeks (end of treatment)
|
53.337 T-score
Standard Deviation 8.190
|
52.864 T-score
Standard Deviation 7.896
|
|
Neuro-QOL Depression and Sleep
8 weeks (one month post treatment)
|
55.162 T-score
Standard Deviation 8.193
|
52.290 T-score
Standard Deviation 9.698
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS)
baseline
|
9.695 score on a scale
Standard Deviation 4.869
|
6.970 score on a scale
Standard Deviation 4.323
|
|
Epworth Sleepiness Scale (ESS)
4 weeks (end of treatment)
|
8.162 score on a scale
Standard Deviation 3.927
|
8.312 score on a scale
Standard Deviation 3.182
|
|
Epworth Sleepiness Scale (ESS)
8 weeks (one month post treatment)
|
8.169 score on a scale
Standard Deviation 4.041
|
8.133 score on a scale
Standard Deviation 3.899
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
CNS Vital Signs TBI Rehab Toolbox
baseline
|
79.59 score on a scale
Standard Deviation 26.260
|
82.83 score on a scale
Standard Deviation 21.805
|
|
CNS Vital Signs TBI Rehab Toolbox
4 weeks (end of treatment)
|
83.19 score on a scale
Standard Deviation 27.489
|
77.64 score on a scale
Standard Deviation 37.658
|
|
CNS Vital Signs TBI Rehab Toolbox
8 weeks (one month post treatment)
|
86.17 score on a scale
Standard Deviation 28.051
|
79.10 score on a scale
Standard Deviation 35.443
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Cognitive Failures Questionnaire
baseline
|
47.823 score on a scale
Standard Deviation 16.872
|
42.806 score on a scale
Standard Deviation 15.175
|
|
Cognitive Failures Questionnaire
4 weeks (end of treatment)
|
45.261 score on a scale
Standard Deviation 17.590
|
46.564 score on a scale
Standard Deviation 16.646
|
|
Cognitive Failures Questionnaire
8 weeks (one month post treatment)
|
47.503 score on a scale
Standard Deviation 18.204
|
45.352 score on a scale
Standard Deviation 18.310
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksThe 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Neuro-QOL Anxiety
baseline
|
55.725 T score
Standard Deviation 8.137
|
56.253 T score
Standard Deviation 7.581
|
|
Neuro-QOL Anxiety
4 weeks (end of treatment)
|
55.250 T score
Standard Deviation 8.929
|
56.661 T score
Standard Deviation 7.766
|
|
Neuro-QOL Anxiety
8 weeks (one month post treatment)
|
57.441 T score
Standard Deviation 8.073
|
55.226 T score
Standard Deviation 8.828
|
SECONDARY outcome
Timeframe: 4 weeks post treatmentPopulation: After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.
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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=30 Participants
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)
n=23 Participants
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.
|
|---|---|---|
|
Actiwatch Spectrum - Acrophase
|
15.68 hours
Standard Deviation 2.29
|
15.98 hours
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 4 weeks post treatmentPopulation: After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.
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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=30 Participants
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)
n=23 Participants
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.
|
|---|---|---|
|
Actiwatch Spectrum - Mesor
|
0.72 score on a scale
Standard Deviation 0.21
|
0.83 score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 4 weeks post treatmentPopulation: After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and in the 23 red arm.
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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=30 Participants
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)
n=23 Participants
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.
|
|---|---|---|
|
Actiwatch Spectrum - F Statistic
|
1765.36 score on a scale
Standard Deviation 1120.32
|
2307.38 score on a scale
Standard Deviation 1574.54
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeksSatisfaction 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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Satisfaction With Life Scale
baseline
|
17.409 score on a scale
Standard Deviation 6.956
|
18.698 score on a scale
Standard Deviation 7.386
|
|
Satisfaction With Life Scale
4 weeks (end of treatment)
|
17.622 score on a scale
Standard Deviation 7.154
|
18.394 score on a scale
Standard Deviation 7.925
|
|
Satisfaction With Life Scale
8 weeks (one month post treatment)
|
17.441 score on a scale
Standard Deviation 6.219
|
19.900 score on a scale
Standard Deviation 6.707
|
SECONDARY outcome
Timeframe: at 4 weeks (end-of-treatment)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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=44 Participants
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)
n=44 Participants
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.
|
|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication
|
42.455 score on a scale
Standard Deviation 29.827
|
47.546 score on a scale
Standard Deviation 33.112
|
SECONDARY outcome
Timeframe: at 4 weeks (end-of-treatment)Population: Compared to other outcome measures, fewer CEQ records were analyzed due to participant non-compliance.
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.
Outcome measures
| Measure |
Bright White Light (BWL)
n=43 Participants
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)
n=37 Participants
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.
|
|---|---|---|
|
Credibility/Expectancy Questionnaire
|
-.5539 score on a scale
Standard Deviation 2.577
|
.4489 score on a scale
Standard Deviation 2.74
|
Adverse Events
Bright White Light (BWL)
Dim Red Light (DRL)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bright White Light (BWL)
n=44 participants at risk
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)
n=44 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Blurred vision
|
2.3%
1/44 • 8 weeks
|
0.00%
0/44 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place