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OpenTrials
Completed

NCT Number: NCT03691766

Photobiomodulation Therapy 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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marquette University

Milwaukee, Wisconsin, 53201-1881, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation Therapy

Other

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

Other

Device with sham light source

Primary outcomes

  1. 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

  1. Systemic Inflammation

    Time frame: up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention

    Change in pro- and anti-inflammatory cytokines.

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Collaborators

  • University of Wisconsin, Milwaukee

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2018
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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