FES Cycling for Multiple Sclerosis

Overseen By Myriam Venasse

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Ottawa

Must not be taking: Dalfampridine

Disqualifiers: Epilepsy, Pacemaker, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with multiple sclerosis (MS) manage mobility issues, which can greatly affect daily life. Researchers are testing whether a special exercise, called functional electrical stimulation (FES) cycling, can improve movement and reduce long-term mobility problems. FES cycling uses mild electrical pulses to move leg muscles on a stationary bike, while another group will use the bike without electrical pulses for comparison. Ideal participants for this trial are those with MS who haven't experienced a relapse in the last 30 days and haven't engaged in similar exercise programs recently.

As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance mobility solutions for MS patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you must not have used dalfampridine in the past month.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have used dalfampridine in the past month and should have a stable course of disease-modifying therapies over the past 6 months.

What prior data suggests that FES Cycling is safe for managing mobility impairment in MS?

Research has shown that FES (Functional Electrical Stimulation) cycling is safe for people with multiple sclerosis (MS). In one study, participants using FES cycling experienced no negative effects or worsening of their MS symptoms, indicating that the treatment is well-tolerated. Another study found that even those with more severe mobility challenges could safely use FES cycling. These studies suggest that FES cycling could be a safe and effective exercise option for managing mobility issues in MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FES Cycling for multiple sclerosis (MS) because it introduces a new way to exercise using functional electrical stimulation (FES). Unlike traditional MS treatments that often rely on medications to manage symptoms, FES Cycling uses electrical impulses to stimulate leg muscles, helping people with MS engage in active cycling movements. This method is unique because it combines aerobic exercise with targeted muscle activation, potentially improving muscle strength and cardiovascular fitness more effectively than passive cycling or medication alone. By offering a non-invasive and active approach to managing MS symptoms, FES Cycling holds promise for enhancing physical function and quality of life in people with MS.

What evidence suggests that FES Cycling is effective for managing mobility impairment in MS?

This trial will compare FES Cycling Exercise with Passive Leg Cycling for individuals with multiple sclerosis (MS). Studies have shown that Functional Electrical Stimulation (FES) cycling, which participants in this trial may receive, can benefit people with moderate-to-severe MS. It may improve overall mobility for those who have difficulty walking. Research suggests that FES cycling not only aids movement but may also enhance thinking skills and reduce symptoms like tiredness and pain. Additionally, combining FES cycling with regular cycling can enable people with severe MS to engage in more intense aerobic exercise. Overall, FES cycling appears to be a safe and effective way to manage mobility issues in individuals with MS. ^{2 5 6 7 8}

Who Is on the Research Team?

Lara Pilutti, PhD

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I don't have symptoms affecting my daily activities.

Willing to come to the University of Ottawa to complete testing and training sessions

Happy to come to University of Ottawa for testing and training.

Exclusion Criteria

You have a medical condition or device that makes it unsafe for you to receive FES treatment, such as epilepsy, a pacemaker, implanted defibrillator, unstable fracture, or pregnancy.

I have taken dalfampridine in the last month.

I have been diagnosed with a neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment and are randomized to either FES or passive leg cycling program

1 week

Treatment

Participants complete a 24-week leg cycling program with mid-point assessment at 12 weeks

24 weeks

Regular sessions (in-person)

Post-intervention Assessment

Participants undergo post-intervention assessment immediately after the 24-week treatment

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment during a 12-week follow-up period

12 weeks

Final assessment at 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FES Cycling Exercise
• Passive Leg Cycling

Trial Overview 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.

How Is the Trial Designed?

Group I: FES Cycling Exercise Experimental Treatment 1 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 Cycling Placebo Group 1 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.

FES Cycling Exercise is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Functional Electrical Stimulation Cycling for:

• Mobility impairment in Multiple Sclerosis
• Rehabilitation for neurological conditions

Approved in Canada as Functional Electrical Stimulation Cycling for:

• Managing mobility disability in Multiple Sclerosis
• Exercise-based rehabilitation for MS

Approved in European Union as Functional Electrical Stimulation Cycling for:

• Rehabilitation for neurological conditions including MS
• Improving mobility and reducing muscle atrophy

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Multiple Sclerosis Society of Canada

Collaborator

Trials

17

Recruited

990+

Published Research Related to This Trial

Functional electrical stimulation (FES) cycling shows promising potential as an exercise training method for individuals with moderate-to-severe multiple sclerosis (MS), with participants able to engage in sessions of about 30 minutes, 2-3 times a week, and experiencing few mild adverse events.

Preliminary evidence suggests that FES cycling may improve physiological fitness, walking mobility, and reduce symptoms of fatigue and pain in people with MS, although more high-quality randomized controlled trials are needed to confirm these benefits and establish clear exercise recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Electrical Stimulation Cycling Exercise for People with Multiple Sclerosis. Pilutti, LA., Motl, RW.[2020]

In a study involving 16 nonambulatory participants with moderate-to-severe multiple sclerosis, functional electrical stimulation (FES) cycling was found to be safe, with no adverse events reported, and it led to significant improvements in fatigue levels.

Participants experienced notable reductions in both physical and psychosocial fatigue, indicating that FES cycling could be an effective exercise option to enhance quality of life for individuals with significant mobility challenges due to MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes After Functional Electrical Stimulation Cycle Training in Individuals with Multiple Sclerosis Who Are Nonambulatory. Backus, D., Burdett, B., Hawkins, L., et al.[2020]

The pilot study involving 10 nonambulatory individuals with multiple sclerosis (MS) demonstrated that functional electrical stimulation (FES) cycling can be safely performed, with no serious adverse events reported and only mild hypotension in two participants.

Participants showed the ability to engage in FES cycling protocols requiring varying levels of effort, with some cycling for 30 minutes, suggesting that higher effort levels may lead to greater functional benefits than previously documented in MS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Various Functional Electrical Stimulation Cycling Protocols in Individuals With Multiple Sclerosis Who Are Nonambulatory. Williams, J., Moldavskiy, M., Bauer, K., et al.[2022]

In a pilot study involving 11 adults with multiple sclerosis, functional electrical stimulation (FES) cycling showed moderate-to-large improvements in cognitive processing speed, fatigue severity, and pain symptoms after 24 weeks of exercise.

The FES cycling exercise led to clinically meaningful changes in cognitive performance and significantly reduced fatigue and pain, suggesting it could be a beneficial rehabilitation method for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Electrical Stimulation Cycling Exercise in People with Multiple Sclerosis: Secondary Effects on Cognition, Symptoms, and Quality of Life. Pilutti, LA., Edwards, T., Motl, RW., et al.[2023]

In a study of 40 participants with multiple sclerosis (MS) over a mean follow-up of 15 months, functional electrical stimulation (FES) cycling as part of rehabilitation showed no progression of disability on the Expanded Disability Status Scale (EDSS).

FES cycling led to improvements or stabilization in lower extremity motor function for 75% of patients with primary progressive MS (PPMS), 71.4% with secondary progressive MS (SPMS), and 54.5% with relapsing remitting MS (RRMS), suggesting it may help preserve or enhance neurological function in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation as a component of activity-based restorative therapy may preserve function in persons with multiple sclerosis. Hammond, ER., Recio, AC., Sadowsky, CL., et al.[2022]

Functional electrical stimulation (FES) cycling is a safe exercise option for nonambulatory individuals with multiple sclerosis (MS), with no adverse events reported in the training group during the 12-week study.

Participants who engaged in FES cycling showed significant improvements in fatigue and quality of life measures, including reduced fatigue scores and enhanced physical health quality of life, compared to a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Functional Electrical Stimulation Cycling on Fatigue and Quality of Life in People with Multiple Sclerosis Who Are Nonambulatory. Backus, D., Moldavskiy, M., Sweatman, WM.[2023]

Functional electrical stimulation (FES) cycling was found to be safe and well-tolerated in five patients with progressive multiple sclerosis (MS) over a six-month period, showing promising improvements in walking ability as measured by the Two Minute Walk Test and other mobility assessments.

Participants also experienced enhancements in quality of life, as indicated by improved scores on the Short-Form 36 (SF-36), suggesting that FES cycling may positively impact both physical and mental health in progressive MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of functional electrical stimulation cycling in progressive multiple sclerosis. Ratchford, JN., Shore, W., Hammond, ER., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5460864/

Outcomes After Functional Electrical Stimulation Cycle ... First, FES cycling may be a safe, accessible, and effective option for people with moderate-to-severe MS who are nonambulatory.

2. ijmsc.org ijmsc.org/view/functional-electrical-stimulation-cycling-exercise-in-people-with-multiple-sclerosis

Functional Electrical Stimulation Cycling Exercise in ... In conclusion, FES cycling exercise might have beneficial effects on cognition and symptoms of fatigue and pain. Larger RCTs are needed to ...

3. msard-journal.com msard-journal.com/article/S2211-0348(24)00131-7/fulltext

Functional electrical stimulation combined with voluntary ... Functional electrical stimulation (FES) cycling combined with voluntary cycling may allow people with severe MS to enhance the intensity of aerobic exercise.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034819304742

Evaluating functional electrical stimulation (FES) cycling on ... Functional electrical stimulation (FES) cycling is used by people with MS (PwMS). · A systematic review evaluated FES cycling in PwMS with a mobility impairment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02606604

Effects of Functional Electrical Stimulation Cycling Versus ... This study will seek to determine the benefits that FES-LE cycling has over cycling alone on walking performance and quality of life in people with multiple ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7853402/

Safety and Feasibility of Various Functional Electrical ... People with multiple sclerosis who are nonambulatory can safely perform functional electrical stimulation (FES) cycling using parameters requiring more effort.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31705304/

Functional Electrical Stimulation Cycling Exercise for ... This review provides a summary of the current evidence for FES cycling as an exercise training modality in persons with MS with respect to prescription, safety ...

8. archives-pmr.org archives-pmr.org/article/S0003-9993(14)00587-5/fulltext

Training Effects and Safety of Functional Electrical ... There were no adverse events, or worsening of MS symptoms. Conclusions. FES cycling may be a viable and effective option of exercise for people with moderate to ...