Restoring Manual Dexterity in Multiple Sclerosis: A Feasibility Study Combining Muscle Electrostimulation and Transcranial Magnetic Stimulation To Enhance Neuroplasticity

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07098273

What it found

Still running

No result yet.

What was tested

Treatment tested

  • TMS and FES- based rehabilitation

Compared with

  • FES-based rehabilitation

What it measured

Main measures

  • 9-Hole Peg Test (9HPT)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

    Disability progressionArm and hand function

Other measures (7)

  • Box and Block Test (BBT)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

    Arm and hand function
  • Arm Function in Multiple Sclerosis Questionnaire (AMSQ)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

    Arm and hand function
  • Symbol Digit Modalities Test (SDMT)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

    Thinking and memory
  • 12-Item Short Form Survey (SF-12)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

  • Fatigue Scale of Motor and Cognitive Functions (FSMC)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

    Thinking and memoryFatigue
  • Intrinsic Motivation Inventory (IMI)

    Before (T0) and after (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks), and at 3 months from T1 (T2).

  • System Usability Scale (SUS)

    After (T1) the rehabilitation treatment (15 sessions of 45 minutes each, 3 times per week for 5 weeks).

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Oct 2025

    2. Main results due

      Dec 2026

    3. Finished

      May 2027

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