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CompletedNCT03691766Updated Feb 26, 2021

Photobiomodulation Therapy in Persons With Multiple Sclerosis

An interventional study of Photobiomodulation Therapy and Placebo in Multiple Sclerosis, Relapsing-Remitting, sponsored by Marquette University. Completed at 1 site in United States. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-26.

Sponsored by Marquette University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2018, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 21 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Marquette University is the lead sponsor of 36 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Photobiomodulation Therapy

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

    Other: Photobiomodulation Therapy

  • Placebo comparator
    Control

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

    Other: Placebo

Interventions

  • OtherPhotobiomodulation 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.

  • OtherPlacebo

    Device with sham light source

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What researchers measure

Primary outcomes

  1. Muscle Fatigue

    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 outcomes

  1. Systemic Inflammation

    Change in pro- and anti-inflammatory cytokines.

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

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Study locations

1 site
  • Marquette University
    Milwaukee, Wisconsin 53201-1881, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03691766
Lead sponsor
Marquette University
Collaborators
University of Wisconsin, Milwaukee
Responsible party
Sponsor
First posted
Oct 2, 2018
Start date
Apr 30, 2018
Primary completion
Sep 23, 2019
Completion
Sep 23, 2019
Last update
Feb 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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