Skip to main content
Clinical Trials/NCT03691766
NCT03691766CompletedNot Applicable

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

Marquette University1 site in 1 country21 target enrollmentStarted: April 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Muscle Fatigue

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •No noticeable left right ankle strength asymmetry
  • •No exacerbations (MS attacks) or immunosuppressive therapy use within the previous 6 months
  • •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.
  • •Not involved in any clinical trial or other research that could confound results.
  • •Must not be pregnant
  • •Must not have an active diagnosis of cancer

Arms & Interventions

Photobiomodulation Therapy

Experimental

Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)

Intervention: Photobiomodulation Therapy (Other)

Control

Placebo Comparator

Placebo device with different wavelengths of light without known physiologic effect.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Muscle Fatigue

Time Frame: 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 Outcomes

  • Systemic Inflammation(up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials