What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as dimethyl fumarate and glatiramer acetate. Dimethyl fumarate can cause side effects like flushing, gastrointestinal issues, and lymphopenia. Glatiramer acetate may lead to injection site reactions, lipoatrophy, and immediate post-injection reactions. For non-pharmacologic treatments like Functional Electrical Stimulation (FES) Cycling, which aims to improve muscle function and mobility, side effects are generally mild and may include skin irritation or discomfort at the site of electrode placement.

What prior FDA approvals exist?

While Functional Electrical Stimulation (FES) Cycling is being studied as a novel rehabilitation strategy for managing mobility impairment in MS, there are no specific FDA-approved treatments that use electrical currents in a similar manner for MS. However, several disease-modifying therapies (DMTs) have been approved by the FDA to manage MS, including oral formulations like dimethyl fumarate (BG-12), which significantly reduce relapse rates and the development of new brain lesions. These treatments aim to slow the progression of disability and manage symptoms, although they do not directly address mobility impairment through electrical stimulation.

What other types of research exist?

Promising, novel alternatives to Functional Electrical Stimulation (FES) Cycling for Multiple Sclerosis patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in improving neurological function and reducing symptoms in various conditions. 2) Spinal Cord Stimulation (SCS), which has been effective in managing chronic pain and could potentially improve mobility and muscle function. Both therapies involve non-invasive or minimally invasive techniques that modulate neural activity to achieve therapeutic effects.

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FES Cycling for Multiple Sclerosis

N/A

Recruiting

Led By Lara Pilutti, PhD

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Asymptomatic based on a physical activity pre-participation screening tool

Stable course of disease-modifying therapies over the past 6 months

Must not have

Diagnosis of other neurological condition(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

Summary

This trial tests whether using electrical impulses to stimulate muscles during cycling can help people with MS who have trouble moving. The goal is to see if this approach can improve muscle strength and mobility better than current treatments.

Who is the study for?

This trial is for people with Multiple Sclerosis who can visit the University of Ottawa for sessions, have an EDSS score between 5.0 and 7.0, haven't had a relapse in the last month, been on stable MS therapies for six months, are not pregnant or have conditions like epilepsy that make FES unsafe.

What is being tested?

The study is examining if using Functional Electrical Stimulation (FES) cycling can help manage mobility problems caused by MS better than just passive leg cycling. Participants will be tested to see if this exercise strategy has long-term benefits.

What are the potential side effects?

While specific side effects aren't listed, FES Cycling may cause muscle fatigue or discomfort due to electrical stimulation. It's important to note contraindications such as epilepsy where seizures could be triggered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't have symptoms affecting my daily activities.

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My treatment for my condition has not changed in the last 6 months.

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I have been diagnosed with multiple sclerosis.

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My disability level is moderate to severe but I can still walk.

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I don't have symptoms affecting my daily activities.

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My treatment for my condition has not changed in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Walking Speed

Secondary study objectives

Change in Activities of Daily Living

Change in Agility

Change in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery

+8 more

Other study objectives

Change in Body Composition

Change in Cardiorespiratory Fitness

Change in Muscular Fitness

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FES Cycling ExerciseExperimental Treatment1 Intervention

FES cycling will involve systematic, transcutaneous electrical stimulation of the leg muscles to produce leg-cycling movement. The intensity and duration of training will be prescribed based on guidelines for aerobic exercise training for persons with MS and from the American College of Sports Medicine, and will progressively increase across 24 weeks. Participants will be encouraged to actively cycle at a minimum cadence of \~40-50 rpm, at 40-60% VO2peak for between 10-50 minutes. The intensity of stimulation will be adjusted per leg muscle group based on sensory tolerance with the goal of maintaining pedaling action and target heart rate over the entire session. At each session, we will record the distance traveled, energy expended, power output, resistance, heart rate and rating of perceived exertion (RPE).

Group II: Passive Leg CyclingPlacebo Group1 Intervention

Passive leg cycling will involve movement of the participant's legs by the cycle ergometer motor without electrical stimulation. The duration of training will follow the same schedule as the FES cycling condition and the same data will be recorded at each session. The passive cycling condition will include the same exposure with the training facility, the exercise equipment (i.e. RT300 cycles), and the research staff (i.e. social contact and attention) as with the FES cycling condition.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) that target the immune system to reduce inflammation and slow disease progression, and symptomatic treatments that manage specific symptoms like spasticity, fatigue, and mobility issues. Functional Electrical Stimulation (FES) Cycling, a symptomatic treatment, uses electrical currents to stimulate muscle contractions, improving muscle function and mobility. This is particularly important for MS patients as it can help maintain muscle strength, enhance mobility, and potentially slow the progression of disability, thereby improving overall quality of life.

Safety and Feasibility of Various Functional Electrical Stimulation Cycling Protocols in Individuals With Multiple Sclerosis Who Are Nonambulatory.Functional Electrical Stimulation Cycling Exercise for People with Multiple Sclerosis.