Clinical trial NCT03691766: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
First posted: 2018-10-02
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Muscle Fatigue
timeFrame: up to 4 week photobiomodulation intervention, immediately after the intervention, and then 4 months after this extended treatment
Secondary outcomes:
measure: Systemic Inflammation
timeFrame: up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
References: