Trial Outcomes & Findings for Light Therapy as Treatment for Fatigue in Multiple Sclerosis (NCT NCT03060759)
NCT ID: NCT03060759
Last Updated: 2020-05-13
Results Overview
Measure of general level of fatigue. Range: 9 to 63. Lower scores indicate less reported fatigue.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
Light Therapy-Spectrum 1
Light from 'active' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
Light Therapy-Spectrum 2
Light from 'placebo' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
15
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Row population is equal to overall population.
Baseline characteristics by cohort
| Measure |
Light Therapy-Spectrum 1
n=20 Participants
Light from 'active' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
Light Therapy-Spectrum 2
n=15 Participants
Light from 'placebo' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Row population is equal to overall population.
|
0 Participants
n=7 Participants • Row population is equal to overall population.
|
0 Participants
n=5 Participants • Row population is equal to overall population.
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants • Row population is equal to overall population.
|
15 Participants
n=7 Participants • Row population is equal to overall population.
|
35 Participants
n=5 Participants • Row population is equal to overall population.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Row population is equal to overall population.
|
0 Participants
n=7 Participants • Row population is equal to overall population.
|
0 Participants
n=5 Participants • Row population is equal to overall population.
|
|
Age, Continuous
|
47.2 years
n=5 Participants
|
41.9 years
n=7 Participants
|
44.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
15 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Years since first diagnosis
|
12.39 years
n=5 Participants
|
8.93 years
n=7 Participants
|
10.9 years
n=5 Participants
|
|
Expanded Disability Status Scale Score
|
3.1 units on a scale
n=5 Participants
|
3.1 units on a scale
n=7 Participants
|
3.1 units on a scale
n=5 Participants
|
|
Type of Multiple Sclerosis
Relapsing-remitting MS
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Type of Multiple Sclerosis
Primary Progressive MS
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 4 participants were withdrawn from the study before providing outcome data.
Measure of general level of fatigue. Range: 9 to 63. Lower scores indicate less reported fatigue.
Outcome measures
| Measure |
Light Therapy-Spectrum 1
n=17 Participants
Light from 'active' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
Light Therapy-Spectrum 2
n=14 Participants
Light from 'placebo' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
|---|---|---|
|
Change in Average Fatigue Severity Scale (FSS) Score
|
45.824 score on a scale
Standard Deviation 11.8
|
46.714 score on a scale
Standard Deviation 10.2
|
Adverse Events
Light Therapy-Spectrum 1
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Light Therapy-Spectrum 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Light Therapy-Spectrum 1
n=17 participants at risk
Light from 'active' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
Light Therapy-Spectrum 2
n=14 participants at risk
Light from 'placebo' spectrum
Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
|
|---|---|---|
|
Nervous system disorders
Headache
|
47.1%
8/17 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
7.1%
1/14 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
|
General disorders
Difficulty Sleeping
|
17.6%
3/17 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
0.00%
0/14 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
|
Eye disorders
Eye issues
|
5.9%
1/17 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
14.3%
2/14 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
|
General disorders
Dizziness
|
5.9%
1/17 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
0.00%
0/14 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
|
General disorders
Fatigue
|
5.9%
1/17 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
0.00%
0/14 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
|
General disorders
Hot flash
|
5.9%
1/17 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
0.00%
0/14 • Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
4 participants were withdrawn from the study prior to collection of adverse event data.
|
Additional Information
Farrah J. Mateen, MD, PhD, Associate Professor of Neurology
Massachusetts General Hospital
Phone: 617-724-8653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place