Photobiomodulation Therapy in Persons With Multiple Sclerosis

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

April 30, 2018

Estimated Primary Completion Date

April 29, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Photobiomodulation Therapy in Persons With Multiple Sclerosis

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

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.
Other: Placebo
Device with sham light source

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 31, 2019

Estimated Primary Completion Date

April 29, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Marquette University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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