Photobiomodulation Therapy in Persons With Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691766
• Other study ID #: HR-1710020115
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: September 23, 2019

Study information

• Verified date: February 2021
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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
Device with sham light source

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Marquette University	University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systemic Inflammation	Change in pro- and anti-inflammatory cytokines.	up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention