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Improving Hand Movement and Coordination in People With Multiple Sclerosis Using Transcranial Magnetic Stimulation (TMS) and Muscle Electrostimulation (FES) To Support Manual Dexterity and Daily Function

NCT07098273

Not Yet RecruitingNA

Sponsor: Fondazione Don Carlo Gnocchi ETS

Conditions: Multiple Sclerosis

Interventions: TMS and FES- based rehabilitation, FES-based rehabilitation

Countries: Italy

The goal of this interventional study is to test whether combining transcranial magnetic stimulation (TMS) with functional electrical stimulation (FES) can improve hand and upper limb function in adults with Multiple Sclerosis (MS). The clinical trial aims to determine the following points: 1. Whether TMS combined with FES produces greater effects compared to FES alone. 2. Changes in brain and muscle activity related to hand function after treatment. 3. Specific clinical or neurophysiological factors that predict who will benefit most from the intervention. Researchers will compare the TMS-FES group (receiving brain magnetic stimulation and muscle electrostimulation) with the FES group (receiving only muscle electrostimulation) to assess whether TMS provides additional benefits in improving upper limb function Participants will: * Be assigned to a group (TMS-FES group or FES group) * Attend 15 sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises, during which FES, or TMS and FES, will be administered to the participant. * Undergo assessments before, after, and 3 months after training to measure hand function, brain and muscle responses, fatigue, and daily activity performance.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* age \>18;
* diagnosis of MS (according to McDonald criteria);
* stable disease course without a worsening greater than 1 point on the Expanded Disability Status Scale (EDSS) in the past 4 months;
* right-handed;
* score on the Box and Block test lower than the normative value adjusted for sex and age +2 standard deviations;
* score on the cerebellar functional system of the EDSS scale \<2;
* ability to provide written informed consent.

Exclusion Criteria:

* score on the Mini-Mental State Examination \<24;
* Beck Depression Inventory-II \>19;
* other neurological or orthopedic conditions that would interfere with upper limb exercises;
* contraindications to the application of TMS: history of epilepsy or non-febrile seizures; presence of metallic or electronic implants in the cranial or cervical region; presence of pacemakers or implantable defibrillators; severe uncontrolled psychiatric disorders (e.g., psychosis, mania); current or suspected pregnancy;
* contraindications to the application of FES: skin integrity issues at the site of electrode placement; implanted electronic devices.

Locations (2)

Genova, Italy, Italy
Milan, Italy, Italy