Status:
NOT_YET_RECRUITING
Pilot Study of tSCS for Improving Upper Limb Function in People With Multiple Sclerosis
Lead Sponsor:
Parc de Salut Mar
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 Mu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07152145
Start Date
October 1 2025
End Date
December 1 2026
Last Update
September 3 2025
Active Locations (1)
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1
Hospital del Mar
Barcelona, Spain, 08003