Functional Electrical Stimulation for Multiple Sclerosis

(FES in MS Trial)

VJ
JB
Overseen ByJeannine Bradsby
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well functional electrical stimulation (FES) aids people with multiple sclerosis (MS) in improving their walking. MS can cause foot drop, which hinders walking and raises the risk of falling. The trial compares FES to a sham (fake) treatment to determine its true impact on mobility and daily life over several months. People with MS who have difficulty walking and haven't recently used FES might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding how FES can enhance mobility in MS patients.

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

The trial does not specify that you need to stop taking your current medications. It mentions that participants can be on any MS therapy or no disease-modifying treatment.

What prior data suggests that this functional electrical stimulation is safe for people with multiple sclerosis?

Research has shown that Functional Electrical Stimulation (FES) is generally safe for people with multiple sclerosis (MS). One study found FES safe for those with a disability score of less than 6.5 on a specific scale, indicating many people with MS can use it without issues. Another study assessed safety by examining side effects or increases in MS symptoms. The results showed that FES did not cause serious side effects or worsen MS symptoms, both immediately after use and the following day. Additionally, NICE, a health authority in the UK, considers FES safe and effective enough to be regularly offered to MS patients. These findings suggest that FES can be a safe option for people with MS seeking to improve their mobility.12345

Why are researchers excited about this trial?

Functional Electrical Stimulation (FES) is unique because it offers a non-invasive way to help manage multiple sclerosis (MS) symptoms by using electrical impulses to stimulate muscles. Unlike traditional medications that primarily target inflammation and immune response, FES directly addresses muscle weakness and mobility issues, which are common in MS. Researchers are excited about FES because it has the potential to improve muscle strength and enhance mobility without the side effects associated with many pharmaceuticals. This approach could offer a complementary option to existing MS treatments, providing a new avenue for improving quality of life for patients.

What evidence suggests that functional electrical stimulation is effective for multiple sclerosis?

This trial will compare the effects of Functional Electrical Stimulation (FES) with a sham treatment for people with multiple sclerosis (MS). Studies have shown that FES can significantly improve walking speed in individuals with MS. For example, some patients experienced a 27% increase in walking speed after 20 weeks of FES treatment. Research also indicates that FES can ease walking and enhance overall quality of life by reducing foot drop, a common MS issue where the front part of the foot drops due to weakness. Long-term studies suggest these benefits can persist, with some patients maintaining improved walking speed even after five years. FES may also help reduce muscle stiffness, fatigue, and pain, further enhancing mobility and comfort.678910

Who Is on the Research Team?

VB

Valerie Block, DPTSc

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people with multiple sclerosis who have trouble walking due to muscle weakness, especially foot drop. Participants should be able to use a wearable device and not have other health issues that would prevent safe participation.

Inclusion Criteria

My disability level is between mild and needing a walker or two canes to walk.
Availability of Wi-Fi in the home or workspace for connectivity
My affected leg muscles are weak but I can move them slightly.
See 3 more

Exclusion Criteria

Musculoskeletal or cardiovascular comorbidities that place the patient at risk as judged by study physical therapists
I have had a recent relapse that affected my walking in the past 30 days.
My muscle stiffness makes passive movement difficult.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks
2-3 visits (in-person)

Baseline Assessment

Participants complete baseline assessments including neurological exams and patient-reported outcomes

1-2 weeks
2-3 visits (in-person)

Epoch A

Group 1 receives 4 months of FES; Group 2 receives 4 months of sham stimulation

4 months
Monthly assessments (in-person)

Epoch B

Both groups receive 4 months of FES

4 months
Monthly assessments (in-person)

Follow-up

Participants are monitored for carryover effects without FES

1 month
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Functional Electrical Stimulation (FES)

Trial Overview

The study tests whether using functional electrical stimulation (FES) on the weaker leg helps improve walking and daily activity in people with MS. Participants are randomly assigned to real or sham FES for 4 months, then all receive FES before a follow-up period without it.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Group 1: FES FullActive Control1 Intervention
Group II: Group 2: FES ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Evaluating the Effect of Functional Electrical Stimulation Used ...

Functional electrical stimulation (FES) can improve walking in people with MS, but its effect on HRQOL is not well established. This review investigated the ...

Effect of a 2-Week Trial of Functional Electrical Stimulation ...

These results suggest that use of FES can significantly improve gait speed, decrease the impact of MS on walking ability, and improve QOL in ...

Functional electrical stimulation (FES)

Research and experience has shown that treatment with FES produces a more normal walking pattern, enabling people to walk faster, further and ...

Effectiveness of Functional Electrical Stimulation on ...

After 20 weeks, treatment responders displayed a 27% average improvement in their walking speed. No significant training effect was found.

Functional Electrical Stimulation (FES) for Treatment of ...

Focus of the Report: This report focuses on the use of functional electrical stimulation (FES) for treatment of dropped foot in patients who have multiple ...

Outcomes After Functional Electrical Stimulation Cycle ... - PMC

These findings suggest that FES cycling is safe for people with MS who have Expanded Disability Status Scale (EDSS) scores less than 6.5 and may provide some ...

Safety and Feasibility of Various Functional Electrical ...

The primary outcome was safety, measured by adverse events and increase in MS symptoms, all assessed throughout, immediately post- and 1 day postsession.

Functional Neuromuscular Electrical Stimulation, Robotic- ...

Functional electrical stimulation significantly improved balance as assessed with the Berg Balance Scale (BBS; ranging from 0 to 56, with higher scores ...

Feasibility of Telerehabilitation-Monitored Functional ...

Telerehabilitation was safe and feasible for FES intervention, and improvements in functional mobility and QOL were observed.

DME.00022 Functional Electrical Stimulation (FES)

This document reviews functional electrical stimulation (FES) and threshold electrical stimulation (TES) and concludes that both are considered investigational ...