FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis.

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07706114
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Use of functional electrical stimulation for extended duration on the participants' weaker limb — DEVICE
    Participants will be randomized into two groups. Group 1: will receive FES during EPOCH A (4 months) and EPOCH B (4 months). Group 2 (delayed start): will receive 4 months of Sham stimulation during EPOCH A, and FES during EPOCH B. Follow-up: After Epoch B, all participants will be followed for 1 month with no FES sleeve or stimulation to assess carryover.

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Jul 2, 2029
Completion
Oct 30, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Group 2: FES Sham
    This group will receive 4 months of sham stimulation followed by 4 months of functional electrical stimulation.
  • Active Comparator: Group 1: FES Full
    This group will receive 8 months of functional electrical stimulation.

Primary Outcome Measure

Adherence [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Francisco, Weill Institute for NeurosciencesSan FranciscoCalifornia94158-

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By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of California San Francisco, Weill Institute for Neurosciences· San Francisco, CA

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