NCT06261528

Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

A Phase I Study of Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Each visit will take about 3 hours. Participants will also be asked to collect saliva, wear the home sleep monitor, and complete surveys. The total study duration is about 2.5 months. The risks of this study include the possibility of eye irritation during the light therapy, and loss of confidentiality. The primary outcome will be the treatment emergent adverse events. There is a number of exploratory efficacy and mechanism of action outcomes for future study design.

Conditions

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Light therapy	Light therapy aimed at alleviating fatigue through circadian rhythm synchronization

Timeline

• Start date: 2024-04-18
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-02-15
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study