University of Texas Southwestern Medical Center
The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team.
This will be an open label, single arm, single center, phase 1 research study designed to determinate the safety and mechanism of action of targeted light therapy as a treatment for fatigue in people with progressive multiple sclerosis (PMS). Participants will undergo a 2-week screening that includes an at home sleep monitor, saliva collection, and completion of surveys. Once screening is complete, participants will complete a light therapy program that will require visits to UT Southwestern Medical Center each day for 3 days, and then every 2-3 weeks for three visits, for a total of 7 visits…
Inclusion Criteria: * Age ≥ 18 years old * Diagnosis of PPMS or SPMS according to the 2017, or 2010 Revised McDonald Criteria * In the opinion of the investigator, able to complete study procedures * Epworth Sleepiness Scale (ESS) ≥ 9 * Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening * Pharmacological and non-pharmacological mood and fatigue treatments must be stable for the previous three months prior to screening and must have intent to keep these stable for the duration of study treatment Exclusion Criteria: * Sleep onset lat…
Light therapy aimed at alleviating fatigue through circadian rhythm synchronization
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