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

ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorParc de Salut Mar

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active stimulation tSCS

    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.

  • Sham: stimulations using a non-active electric stimulation

    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

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active tSCS + RehabilitationExperimental treatment 2 interventions
Group B: Sham tSCS + RehabilitationSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Upper Limb Function (9-Hole Peg Test)

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.

Time frame
Baseline and Week 12

Secondary outcomes

1

Change in Hand Grip Strength (Dynamometry)

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.

Time frame
Baseline and Week 12
2

Change in Quality of Life (EQ-5D-5L)

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.

Time frame
Baseline and Week 12
3

Change in Fatigue (Modified Fatigue Impact Scale - MFIS)

Self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial functioning. Change from baseline will be analyzed.

Time frame
Baseline and Week 12
4

Change in Manual Dexterity (Box and Block Test)

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

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Parc de Salut Mar

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: