TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation

Effects of Transcranial Magnetic Stimulation Combined With Virtual Reality, Multidisciplinary Rehabilitation, and Cardiac Autonomic Modulation in Multiple Sclerosis: A Clinical Trial

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT07593807

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Transcranial Magnetic Stimulation
  • Physiotherapy
  • Non-immersive serious game training

What it measured

Main measures

  • Cardiac autonomic modulation (heart rate variability)

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

Other measures (19)

  • Systolic and Diastolic Blood Pressure

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

  • Heart Rate

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

  • Respiratory Rate

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

    Bladder, bowel and sexual function

  • Oxygen Saturation

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

  • Mini-Mental State Examination (MMSE)

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

    Thinking and memory

  • Five Digits Test (FDT)

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

    Thinking and memory

  • WAIS-III Digit Span

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

    Thinking and memory

  • Verbal Fluency Tests

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

  • Psychological Battery for Attention Assessment (BPA)

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

    Thinking and memory

  • Beck Depression Inventory - Second Edition (BDI-II)

    Baseline (Day 1) and Day 10 of each intervention phase (active and sham), with a washout period of at least 4 weeks between phases.

    Mood and sleep

Who could take part

MS (type not specified) · 20 to 70

Show the full criteria

Inclusion criteria

* Participants with a confirmed diagnosis of Multiple Sclerosis. * Ability to understand and follow simple instructions and to participate in the experimental procedures. * Expanded Disability Status Scale (EDSS) score ≤ 6.5. * Ability to maintain upright standing position (with or without assistive device) and perform basic static and dynamic balance tasks required for the intervention.

Exclusion criteria

* Presence of metallic implants in the skull, cranial deformities, or absence of cranial vault. * Cardiac arrhythmias or atrioventricular block. * Congenital abnormalities, including congenital heart disease or pulmonary malformations. * History of seizures. * Use of medications that significantly interfere with autonomic nervous system function, such as antiarrhythmic drugs or insulin. * Inability to perform the proposed physical and virtual reality-based exercises. * Inability to tolerate neuromodulation or electrostimulation procedures. * Non-attendance at baseline or post-intervention assessment sessions, or absence in three or more intervention sessions. * Incomplete completion of study procedures or withdrawal for any reason.

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a chronic autoimmune central nervous system disease characterized by inflammation, demyelination, and neurodegeneration, resulting in motor, cognitive, speech-language, psychological, and cardiac autonomic impairments. This double-blind, randomized, controlled crossover trial investigates the effects of repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (Cz) and left dorsolateral prefrontal cortex (F3), combined with virtual reality (VR)-based exercise (MoveHero platform) and conventional physiotherapy, in 30 individuals with MS (EDSS 1.0-6.5). Participants are randomized to Active-then-Sham or Sham-then-Active sequence groups. Each phase consists of 10 consecutive weekday rTMS sessions, followed by at least four weeks washout before crossover. Both targets use a circular coil at 10 Hz. Cz is stimulated at 90% resting motor threshold (30 trains, 50 pulses/train) and F3 at 110% resting motor threshold (40 trains, 50 pulses/train). The sham condition replicates the procedure with the coil inverted at 10% intensity. On six of ten intervention days, rTMS is followed by VR exercise and balance-focused physiotherapy. Outcomes assessed at baseline and post-intervention include cardiac autonomic modulation (heart rate variability), balance, functional mobility, manual dexterity, fatigue, quality of life, depression, attention, executive function, working memory, psychological well-being, verbal fluency, and speech-language function (aphasia, dysphagia, dysarthria, voice quality). Follow-up reassessments are conducted at six months and one year.

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History

    1. Started

      Feb 2025

    2. Main results due

      Oct 2025

    3. Finished

      Sept 2026

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