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Search / Trial 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

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Jul 25, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Multiple Sclerosis Hand Dexterity Technology Based Rehabilitation Functional Electrical Stimulation Transcranial Magnetic Stimulation

ClinConnect Summary

This clinical trial is studying whether a combination of two treatments—transcranial magnetic stimulation (TMS), which uses magnetic pulses to stimulate the brain, and functional electrical stimulation (FES), which uses small electrical currents to activate muscles—can help improve hand and arm movement in adults with Multiple Sclerosis (MS). The main goal is to see if using both treatments together works better than using electrical stimulation on its own to support hand strength and coordination, which are important for daily activities.

Adults with MS who have some difficulty with hand movement and meet certain health criteria may be eligible to join. Participants will be assigned to one of two groups: one will receive both brain and muscle stimulation (TMS-FES), and the other will receive only muscle stimulation (FES). They will take part in 15 sessions of guided hand and arm exercises over five weeks, with treatments given during these sessions. Their hand function, brain and muscle responses, fatigue, and ability to do daily tasks will be checked before, right after, and three months after the program to see how well the treatments work. This study could help identify who benefits most from these therapies, offering new hope for improving hand use in people with MS.

Gender

ALL

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.

About Fondazione Don Carlo Gnocchi Onlus

Fondazione Don Carlo Gnocchi Onlus is a distinguished non-profit organization dedicated to advancing healthcare and rehabilitation services for individuals with disabilities and chronic illnesses. Established in honor of the legacy of Don Carlo Gnocchi, the foundation focuses on integrating scientific research with clinical practice, striving to enhance the quality of life for patients through innovative therapies and comprehensive care programs. With a commitment to excellence, the foundation actively engages in clinical trials and research initiatives aimed at improving treatment outcomes and fostering a deeper understanding of rehabilitation methodologies. Its collaborative approach brings together healthcare professionals, researchers, and community stakeholders to promote well-being and support patient-centric solutions.

Locations

Genova, , Italy

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Tiziana Lencioni, PhD

Principal Investigator

IRCCS "Santa Maria Nascente" - Fondazione Don Gnocchi

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported