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Electrical stimulation of the weaker leg to help walking in multiple sclerosis

Tests electrical stimulation of the weaker leg in adults with multiple sclerosis.

Plain-language title generated from the registry record
Registry title: FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis.

Key facts

Where
San Francisco, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 22 and 75 years old?

Source: NCT07706114, who can take part

Where in United States

  • University of California San Francisco, Weill Institute for NeurosciencesSan Francisco, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of California, San Francisco
Trial code
NCT07706114
Record updated
15 September 2026
Original description
Multiple sclerosis (MS) is a chronic, neurodegenerative disease and the most common cause of non- traumatic disability in young adults. Foot drop, arising from MS-induced muscle weakness, leads to impaired mobility, increased fall risk, reduced overall physical activity and reduced health-related quality of life. Functional electrical stimulation (FES) represents a revolutionary approach for addressing gait mobility challenges in MS and evolution in the technology has greatly improved its design, comfort, and functionality. Despite its proven benefits, FES is underutilized in MS clinical practice and lacks a comprehensive assessment of its long-term effectiveness and impact in real-world applications. Study objectives are to evaluate the utility of FES for improving function and real-world outcomes in people with MS (PwMS) who have gait impairments. Study design: 4-month randomized controlled trial (RCT) (n=70 PwMS) evaluating FES efficacy. Group 1: 4M FES; Group 2: 4M sham stimulation, followed by both groups: 4M FES, then 1M (no-FES) follow-up assessing carryover. We will assess gait quality, muscle function, physical activity, and FES adoption factors, with covariates including age, sex, MS severity, MS symptoms, biomechanical factors, and device usage patterns.Read full original descriptionShow less

Functional Electrical Stimulation: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, neurodegenerative disease and the most common cause of non- traumatic disability in young adults. Foot drop, arising from MS-induced muscle weakness, leads to impaired mobility, increased fall risk, reduced overall physical activity and reduced health-related quality of life. Functional electrical stimulation (FES) represents a revolutionary approach for addressing gait mobility challenges in MS and evolution in the technology has greatly improved its design, comfort, and functionality. Despite its proven benefits, FES is underutilized in MS clinical practice and lacks a comprehensive assessment of its long-term effectiveness and impact in real-world applications. Study objectives are to evaluate the utility of FES for improving function and real-world outcomes in people with MS (PwMS) who have gait impairments. Study design: 4-month randomized controlled trial (RCT) (n=70 PwMS) evaluating FES efficacy. Group 1: 4M FES; Group 2: 4M sham stimulation, followed by both groups: 4M FES, then 1M (no-FES) follow-up assessing carryover. We will assess gait quality, muscle function, physical activity, and FES adoption factors, with covariates including age, sex, MS severity, MS symptoms, biomechanical factors, and device usage patterns.

Inclusion: Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria79; Ages 22-75 years old; EDSS 2 - 6.5 (wide range of impairment, 6.5 = ambulation requires walker or 2 canes); ≥ 1/5 (and <5/5 on manual muscle test) of affected leg muscles; Any MS therapy, or no disease modifying treatment; Technological criteria: availability of Wi-Fi in the home or workspace for connectivity.

Exclusion: Cognitive, dexterity or visual impairment that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to comply with the study protocol; Inability to provide informed consent; FES use in the last 6 months; Musculoskeletal / cardiovascular comorbidities that in the opinion of the study physical therapists (VB, JB), places the patient at risk; Recent (last 30 days) relapse affecting gait; >2/4 on the Ashworth scale (3= passive movement difficult).

ClinicalTrials.gov NCT07706114