Light Therapy as Treatment for Fatigue in Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT03060759

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Light Therapy box

Results by group

Change in Average Fatigue Severity Scale (FSS) Score

4 weeks

GroupValueIntervalNumber analysed
Light Therapy-Spectrum 145.824 score on a scale11.8 (Standard Deviation)17
Light Therapy-Spectrum 246.714 score on a scale10.2 (Standard Deviation)14

Light Therapy-Spectrum 1

45.824

Light Therapy-Spectrum 2

46.714

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Light Therapy-Spectrum 1170 (0.0%)0
Light Therapy-Spectrum 2140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in Average Fatigue Severity Scale (FSS) Score

    4 weeks

    Fatigue

Who could take part

Relapsing MS · 18 to 70

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Apr 2017

    2. Main results due

      Jun 2019

    3. Finished

      Nov 2019

    4. Results posted

      May 2020

    Assembled by software from public sources.