Pilot Study of tSCS for Improving Upper Limb Function in People With Multiple Sclerosis

NCT07152145 · tracked via the Priya Life Science Spain tracker

Sponsor

Parc de Salut Mar

Phase

Not applicable

Started

2025-10

Last updated

2025-09-03

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Active stimulation tSCSSham: stimulations using a non-active electric stimulationOccupational/Upper Limb Rehabilitation Therapy

Active stimulation tSCS: Active transcutaneous spinal cord stimulation (tSCS) delivered with the SCONE™ device. Electrical currents are applied non-invasively through surface electrodes placed on the skin over the spine. Sessions are combined with standardized upper limb rehabilitation therapy. Participants receive stimulation twice per week for 12 weeks.

Sham: stimulations using a non-active electric stimulation: Sham stimulation delivered with the SCONE™ device, using identical setup and procedures as the active intervention but without effective current. This procedure is designed to mimic the sensation and experience of active stimulation while delivering no therapeutic neuromodulation. Participants also perform standardized upper limb rehabilitation therapy twice per week for 12 weeks.Transcutaneous Spinal Cord Stimulation (tSCS) - Sham (SCONE™)

Occupational/Upper Limb Rehabilitation Therapy: Standardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation.

Study summary

The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Age between 18 and 70 years. * Diagnosis of Multiple Sclerosis (according to revised McDonald criteria). * Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values). * Stable disease-modifying treatment for ≥ 6 months before enrollment. * Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5. * Ability to provide informed consent. Exclusion Criteria: * Relapse or corticosteroid treatment within the last 3 months. * Severe spasticity of the upper limb (Modified Ashworth Scale \> 3). * Implanted electrical devices (pacemaker, spinal cord stimulator). * Epilepsy or uncontrolled seizures. * Severe psychiatric disorders or cognitive impairment interfering with study procedures. * Pregnant or breastfeeding women. * Participation in another interventional clinical trial within the last 3 months.

Primary outcome measure(s)

Change in Upper Limb Function (9-Hole Peg Test) — Baseline and Week 12
The 9-Hole Peg Test (9HPT) is a validated quantitative measure of upper extremity function. Participants are timed while placing and removing nine pegs into holes on a board as quickly as possible. Performance is recorded as time to completion. Change from baseline will be compared between active and sham groups.

Trial sites (1)

Facility	City	Region	Status
Hospital del Mar	Barcelona	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07152145 on ClinicalTrials.gov ↗ ← All trials in Spain