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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active tSCS + Rehabilitation

Participants will receive active transcutaneous spinal cord stimulation (tSCS) using the SCONE™ device, combined with conventional upper limb rehabilitation therapy.

Group Type EXPERIMENTAL

Active stimulation tSCS

Intervention Type DEVICE

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.

Occupational/Upper Limb Rehabilitation Therapy

Intervention Type BEHAVIORAL

Standardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation.

Sham tSCS + Rehabilitation

Participants will receive sham stimulation using the SCONE™ device without active current, combined with conventional upper limb rehabilitation therapy. The setup will be identical to the active intervention to maintain blinding.

Group Type SHAM_COMPARATOR

Sham: stimulations using a non-active electric stimulation

Intervention Type DEVICE

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

Intervention Type BEHAVIORAL

Standardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation.

Interventions

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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.

Intervention Type DEVICE

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™)

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No