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

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07152145
• Lead Sponsor: Parc de Salut Mar

Brief 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.

Detailed Description

This is a pilot, randomized, placebo-controlled study designed to evaluate the efficacy and safety of transcutaneous spinal cord stimulation (tSCS) in improving upper limb function in patients with Multiple Sclerosis (MS).

tSCS is a non-invasive neuromodulation technique that delivers low-intensity electrical impulses through the skin to specific spinal segments. This external stimulation aims to enhance spinal excitability and restore communication between the brain and spinal circuits affected by MS. Previous research in spinal cord injury has demonstrated functional improvements in motor performance with tSCS, suggesting its potential benefit in MS-related disability.

In this study, participants with clinically confirmed MS and upper limb impairment will first undergo a 6-week period of standard occupational therapy. After this run-in phase, they will be randomly assigned in a 1:1 ratio to receive either active tSCS or sham stimulation for an additional 6 weeks, while continuing occupational therapy. The intervention will be delivered at the rehabilitation center of Hospital de la Esperanza, in a seated position, using surface electrodes placed at the posterior cervical region. Sessions will last approximately 30 minutes, three times per week (preferably Monday, Wednesday, and Friday).

The sham condition will mimic the procedure using the same equipment and electrode placement but without delivering effective stimulation. After completion of the blinded phase, participants originally randomized to sham will be offered the opportunity to receive active tSCS in an open-label extension.

The primary efficacy endpoint is improvement in upper limb function, assessed by the Nine-Hole Peg Test (9HPT). Secondary endpoints include the Action Research Arm Test (ARAT), patient-reported outcomes (NeuroQOL - Upper Extremity Function, Modified Fatigue Impact Scale \[MFIS\], and Global Impression of Change \[GIC\]), and clinical safety measures.

tSCS is generally safe and well-tolerated. Reported side effects are typically mild and transient, including tingling, skin irritation, or muscle discomfort. Participants will be monitored throughout the study, and adverse events will be recorded.

This pilot trial will provide preliminary data on the clinical utility of tSCS in MS and inform the design of larger randomized controlled trials.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-10-01
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in Hand Grip Strength (Dynamometry)	Baseline and Week 12	Grip strength will be measured using a calibrated hand dynamometer. The mean of three trials per hand will be recorded and analyzed as change from baseline.
Change in Quality of Life (EQ-5D-5L)	Baseline and Week 12	Patient-reported outcome measuring five domains of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Change from baseline will be assessed.
Change in Fatigue (Modified Fatigue Impact Scale - MFIS)	Baseline and Week 12	Self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial functioning. Change from baseline will be analyzed.
Change in Manual Dexterity (Box and Block Test)	Baseline and Week 12	The Box and Block Test measures gross manual dexterity by counting the number of blocks moved from one compartment to another in 60 seconds. Change from baseline will be assessed
Patient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)	Baseline and Week 12	Patient-reported outcome measure assessing the perceived impact of MS on physical function, with specific focus on upper limb-related items. Higher scores indicate greater impact. Change from baseline will be compared.
Safety and Tolerability	Baseline through Week 12	Number and severity of adverse events related to the device or therapy will be recorded throughout the study. Tolerability will be assessed via patient-reported discomfort during stimulation.

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain