Balance Training with Electrical Stimulation for Multiple Sclerosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Visual problems, Cognitive impairment, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different types of balance training can help people with Multiple Sclerosis (MS) improve leg strength and coordination. Participants will either engage in balance training alone or combine it with electrical stimulation techniques that use small electrical pulses to enhance muscle and spinal cord function. The study seeks individuals with MS who can walk at least 100 meters and often experience balance issues during daily activities. Over 12 sessions spanning six weeks, the trial will assess which method best improves mobility and reduces the risk of falls. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance daily life for those with MS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these balance training techniques with electrical stimulation are safe for individuals with Multiple Sclerosis?

Research has shown that combining balance exercises with two types of electrical stimulation—functional electrical stimulation (FES) and transcutaneous spinal cord stimulation (TSCS)—is generally safe for people with multiple sclerosis (MS). Previous studies on FES found it safe, with participants handling it well, even when it required more effort. These studies reported no serious side effects.

For those trying both FES and TSCS together, early results suggest that TSCS is also safe. Participants tolerated the treatment well, and no major safety issues emerged. These treatments aim to improve balance and strength in people with MS, prioritizing safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these balance training techniques for multiple sclerosis (MS) because they involve innovative uses of electrical stimulation, setting them apart from standard therapies like physical therapy and medication. One standout feature is the use of Functional Electrical Stimulation (FES) and Transcutaneous Spinal Cord Stimulation (TSCS), which aim to improve balance by activating the nervous system in ways traditional therapies cannot. This combined neuromodulation could enhance motor function and stability more effectively, providing a new approach to managing MS symptoms. Additionally, this method promises a non-invasive alternative with potentially quicker and more robust improvements in balance, which could significantly enhance quality of life for those with MS.

What evidence suggests that this trial's treatments could be effective for Multiple Sclerosis?

Research has shown that balance exercises combined with Functional Electrical Stimulation (FES) can enhance walking ability and quality of life for people with Multiple Sclerosis (MS). In this trial, some participants will undergo balance training with FES, which studies indicate can increase mobility and reduce MS symptoms.

Another group will receive both FES and Transcutaneous Spinal Cord Stimulation (TSCS) during balance training. This combination aims to improve movement control. Although limited data exists on using both together, FES alone has demonstrated positive results, suggesting that adding TSCS could be beneficial. Overall, these electrical stimulation methods aim to improve balance and reduce the risk of falls in people with MS. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis who have issues with balance, mobility, or vestibular function. Participants should be able to complete a series of balance training sessions and assessments. Specific eligibility criteria are not provided but typically would exclude those with conditions that might interfere with the interventions or assessments.

Inclusion Criteria

I am 65 years old or younger.

I have been diagnosed with Multiple Sclerosis.

I can walk 100 meters without needing to rest, with or without help.

Exclusion Criteria

Uncorrected visual problems

I have a condition affecting my balance.

I have been in rehab therapy (physical, occupational, or vestibular) within the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in balance training with or without electrical stimulation techniques over 6 weeks

6 weeks

12 supervised training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Outcome assessments conducted at 8 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Balance training only
• Balance training with FES
• Balance training with FES and TSCS

Trial Overview The study tests three approaches to improve balance in MS patients: (1) Balance training only, (2) Balance training plus Functional Electrical Stimulation (FES), and (3) Balance training combined with FES and Transcutaneous Spinal Cord Stimulation (TSCS). It aims to see if adding electrical stimulation improves outcomes.

How Is the Trial Designed?

Group I: Balance training wiith combined neuromodulation (TSCS+FES) Active Control 1 Intervention

This group will receive both TSCS \& FES (combined neuromodulation) during balance training

Group II: Balance training with FES Active Control 1 Intervention

This group will receive active FES+ sham TSCS (FES only group) duing balance training

Group III: Balance training only Placebo Group 1 Intervention

Participants in this group complete the standardized balance training program with sham electrical stimulation.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Direct MS Canada

Collaborator

Trials

1

Recruited

40+

Citations

1. ijmsc.org ijmsc.org/view/feasibility-of-telerehabilitation-monitored-functional-electrical-stimulation-on-walking-and-quality-of-life-in-people-with-multiple-sclerosis-a-case-series

Feasibility of Telerehabilitation-Monitored Functional ... The results of this study demonstrate the feasibility of using telerehabilitation to monitor and advance an FES intervention for people with MS.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0031940624004139

Exploring the effectiveness of circuit training rehabilitation ... Circuit training can have positive effects on PwMS in terms of increasing balance, gait, and reducing fatigue. Further research is needed. Systematic Review ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10015930/

A highly challenging balance training intervention for people ... The Multiple Sclerosis Walking Scale indicated improvement in the way participants perceived the impact of MS on their walking ability. However, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148216310942

Effects of Functional Electrical Stimulation on Reducing ... The results of this study demonstrate that in group of patients with multiple sclerosis and stroke, a walking training protocol with FES for 8 weeks benefited ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6709571/

Evaluating the Effect of Functional Electrical Stimulation Used ... This review provides preliminary evidence that FES has a positive effect on aspects of HRQOL in people with MS; however, the variety of HRQOL outcomes used ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S2211034824000373

The effects of hybrid functional electrical stimulation ... Improving aerobic fitness in people with advanced multiple sclerosis (MS) may reduce fatigue, and lower the risk of cardiovascular disease, ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/02692155251384079

Feasibility of home-based high-intensity balance training in ... No severe adverse events attributed to this program were reported. There were significant and small-to-medium improvements in static balance (d ...