N/A
N=35
Light Therapy as Treatment for Fatigue in Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Bottom Line
View on ClinicalTrials.gov: NCT03060759 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change in Average Fatigue Severity Scale (FSS) Score — 45.824; 46.714 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Light Therapy box (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Fatigue Severity Scale (FSS) Score |
45.824; 46.714 | — |
Summary
This prospective study will randomize 1:1 people living with multiple sclerosis-associated fatigue to one of two spectra of light therapy. Each participant will be asked to use the light box twice daily at home or at the workplace at preset hours during the day for a total of four weeks. Participants will be asked to record their fatigue on standard measurement scales before, during, and after the use of the light therapy box. The investigators anticipate a reduction in self-reported fatigue following the use of the light box therapy of a particular spectrum of light among people living with multiple sclerosis.
Eligibility Criteria
Inclusion Criteria
- Relapsing remitting Multiple Sclerosis based on the McDonald Criteria (2010)
- Over 18 years old
- Presence of fatigue defined as FSS over 36
Exclusion Criteria
- A change in an anti-depressant up to 4 weeks prior to study screening
- A change in fatigue medication regime or MS disease modifying therapy up to 4 weeks prior to study screening
- Shift work
- Use of photosensitizing medication
- Presence of eye trauma or acute optic neuritis within the preceding 3 months
- History of traumatic brain injury
- Probable (untreated) sleep apnea based on Berlin questionnaire
- Significant anemia
- History of mania
- MS relapse in the preceding four weeks
- Current pregnancy
- Known light sensitivity
- Other complicating illness preventing study completion.
Data sourced from ClinicalTrials.gov (NCT03060759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.