Photobiomodulation Therapy in Persons With Multiple Sclerosis

Effect of Photobiomodulation Therapy on Muscle Function and Inflammation in Persons With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Other: Photobiomodulation Therapy; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201-1881
      • Marquette University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation Therapy; Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)	Other: Photobiomodulation Therapy; Photobiomodulation therapy, a mix of red lights thought to improve mitochondrial function will be applied in and acute and chronic manner to test whether muscle fatigue improves in persons with MS.
Placebo Comparator: Control; Placebo device with different wavelengths of light without known physiologic effect.	Other: Placebo; Device with sham light source

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marquette University
• Collaborators: University of Wisconsin, Milwaukee

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: HR-1710020115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No