Photobiomodulation Therapy in Persons With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Other: Photobiomodulation Therapy; Other: Placebo

• Registration Number: NCT03691766
• Lead Sponsor: Marquette University

Brief Summary

This study will test whether photobiomodulation therapy improves muscle endurance and decreases inflammation in persons with relapsing-remitting multiple sclerosis. We will also investigate mechanisms for any improvements.

Detailed Description

Persons with multiple sclerosis (MS) MS commonly experience muscle weakness and fatigue which may contribute to the commonly reported symptomatic fatigue. Photobiomodulation therapy (PBMT) induced with light in the visible red to near infrared (VIS/NIR) region of the spectrum (600-1000 nm) can stimulate cytochrome c oxidase and improve mitochondrial function. PBMT is an emerging therapeutic modality for soft tissue injury, chronic inflammation, neurodegeneration , and retinal diseases. PBMT has also been used to enhance muscle endurance, strength and recovery in healthy adults. We propose that in persons with MS, PBMT will 1) enhance regional muscle endurance after acute treatment and 2) enhance functional endurance after extended treatment. We will also test to determine if improvements are due to central or peripheral neuromuscular or cardiovascular mechanisms. Final, we will explore if regional PBMT can result in systemic anti-inflammatory effects.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Relapsing remitting MS,
2. Independent or ambulatory with minimal aid.
3. Must be able to move foot (ankle dorsiflexion) at least moderately forcibly against gravity (manual muscle test score 3-5)
4. Subjects must be able to walk for 6 minutes independently with no or minimal use of an assistive device.

Exclusion Criteria

1. No noticeable left right ankle strength asymmetry
2. No exacerbations (MS attacks) or immunosuppressive therapy use within the previous 6 months
3. No concurrent infection or known cardiovascular disease including having a pacemaker; or other serious medical co-morbidity including metabolic, mitochondrial, autoimmune, diseases or other co-existing neurologic conditions.
4. Not involved in any clinical trial or other research that could confound results.
5. Must not be pregnant
6. Must not have an active diagnosis of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation Therapy	Photobiomodulation Therapy	Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)
Control	Placebo	Placebo device with different wavelengths of light without known physiologic effect.

Primary Outcome Measures

Name	Time	Method
Muscle Fatigue	up to 4 week photobiomodulation intervention, immediately after the intervention, and then 4 months after this extended treatment	Change in muscle fatigue or recovery after photobiomodulation therapy

Secondary Outcome Measures

Name	Time	Method
Systemic Inflammation	up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention	Change in pro- and anti-inflammatory cytokines.

Trial Locations

Locations (1)

Marquette University; 🇺🇸 Milwaukee, Wisconsin, United States