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Photobiomodulation Therapy in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photobiomodulation Therapy
Placebo
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marquette University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Photobiomodulation Therapy

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Muscle Fatigue
Change in muscle fatigue or recovery after photobiomodulation therapy

Secondary Outcome Measures

Systemic Inflammation
Change in pro- and anti-inflammatory cytokines.

Full Information

First Posted
September 28, 2018
Last Updated
February 25, 2021
Sponsor
Marquette University
Collaborators
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT03691766
Brief Title
Photobiomodulation Therapy in Persons With Multiple Sclerosis
Official Title
Effect of Photobiomodulation Therapy on Muscle Function and Inflammation in Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
Collaborators
University of Wisconsin, Milwaukee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation Therapy
Arm Type
Experimental
Arm Description
Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo device with different wavelengths of light without known physiologic effect.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Device with sham light source
Primary Outcome Measure Information:
Title
Muscle Fatigue
Description
Change in muscle fatigue or recovery after photobiomodulation therapy
Time Frame
up to 4 week photobiomodulation intervention, immediately after the intervention, and then 4 months after this extended treatment
Secondary Outcome Measure Information:
Title
Systemic Inflammation
Description
Change in pro- and anti-inflammatory cytokines.
Time Frame
up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201-1881
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Photobiomodulation Therapy in Persons With Multiple Sclerosis

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