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
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
Treatments tested in this trial
- Active stimulation tSCS
- Sham: stimulations using a non-active electric stimulation
- Occupational/Upper Limb Rehabilitation Therapy
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov