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

Not Yet RecruitingNA

Sponsor: Parc de Salut Mar

Conditions: Multiple Sclerosis

Interventions: Active stimulation tSCS, Sham: stimulations using a non-active electric stimulation, Occupational/Upper Limb Rehabilitation Therapy

Countries: Spain

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Barcelona, Spain