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

NANot yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

May 31, 2027

Conditions
Multiple Sclerosis
Interventions
DEVICE

TMS and FES- based rehabilitation

"Each subject will receive 15 individual sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises.~Before movement execution, the hand area of the primary motor cortex will be stimulated using active rTMS. The rTMS protocol will use intermittent theta burst stimulation (iTBS), which delivers bursts of 3 pulses at 50 Hz every 200 ms (5 Hz) for 2 seconds, followed by 8 seconds of rest, totaling 600 pulses in \~3 minutes. The hand area will be identified as the optimal site for eliciting a motor evoked potential (MEP) in the abductor digiti minimi (ADM) muscle, contralateral to the dominant limb, with the lowest possible stimulation intensity.~Subsequently, FES will be applied to assist the subject's voluntary movements during the task-oriented activities. The stimulation will be triggered based on the achievement of the electromyographic (EMG) threshold of the selected muscles."

DEVICE

FES-based rehabilitation

"Each subject will receive 15 individual sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises.~Before movement execution, the TMS coil will be positioned over the hand areas of the primary motor cortex, but tilted away from the scalp so as to produce a sound similar to the real intervention, but at a low intensity, without inducing current in the cortex.~FES will then be applied to assist the patient's voluntary movements during the task-oriented activities. The stimulation will be triggered based on the achievement of the electromyographic (EMG) threshold of the selected muscles."

Trial Locations (2)

16149

Fondazione Italiana Sclerosi Multipla, Genova

20148

"IRCCS Santa Maria Nascente - Fondazione Don Gnocchi", Milan

All Listed Sponsors
collaborator

Fondazione Italiana Sclerosi Multipla

OTHER

lead

Fondazione Don Carlo Gnocchi Onlus

OTHER

NCT07098273 - 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 | Biotech Hunter | Biotech Hunter