Photobiomodulation Therapy in Persons With Multiple Sclerosis

NCT03691766 | Completed

• 1 other identifier: HR-1710020115
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Systemic Inflammation

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

Study Arms (2)

Photobiomodulation Therapy

EXPERIMENTAL

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

Other: Photobiomodulation Therapy

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Photobiomodulation Therapy OTHER

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.

Photobiomodulation Therapy

Placebo OTHER

Device with sham light source

Control

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marquette University: lead
• University of Wisconsin, Milwaukee: collaborator

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53201-1881, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: April 30, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)