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Photobiomodulation Therapy in Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03691766
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
Marquette University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Other: Photobiomodulation Therapy Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Photobiomodulation Therapy on Muscle Function and Inflammation in Persons With Multiple Sclerosis
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : September 23, 2019
Actual Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Photobiomodulation Therapy
Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)
 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 Comparator: Control
Placebo device with different wavelengths of light without known physiologic effect.
 Other: Placebo
Device with sham light source


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691766


Locations
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United States, Wisconsin
Marquette University
Milwaukee, Wisconsin, United States, 53201-1881
Sponsors and Collaborators
Marquette University
University of Wisconsin, Milwaukee
More Information
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Responsible Party: Marquette University
ClinicalTrials.gov Identifier: NCT03691766    
Other Study ID Numbers: HR-1710020115
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases