Light Therapy as Treatment for Fatigue in Multiple Sclerosis

NCT03060759 | Completed Results

• 1 other identifier: 2016P002696
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Fatigue; Light Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Average Fatigue Severity Scale (FSS) Score

  Measure of general level of fatigue. Range: 9 to 63. Lower scores indicate less reported fatigue.

  4 weeks

Study Arms (2)

Light Therapy-Spectrum 1

ACTIVE COMPARATOR

Light from 'active' spectrum

Device: Light Therapy box

Light Therapy-Spectrum 2

PLACEBO COMPARATOR

Light from 'placebo' spectrum

Device: Light Therapy box

Interventions

Light Therapy box DEVICE

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 1; Light Therapy-Spectrum 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsing remitting Multiple Sclerosis based on the McDonald Criteria (2010)
• Over 18 years old
• Presence of fatigue defined as FSS over 36

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Farrah J. Mateen, MD, PhD, Associate Professor of Neurology
• Organization: Massachusetts General Hospital

fmateen@mgh.harvard.edu

617-724-8653

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: April 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: November 4, 2019
• Last Updated: May 13, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)