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TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis

Active Not RecruitingNA

Sponsor: University of Sao Paulo

Conditions: Multiple Sclerosis

Interventions: Transcranial Magnetic Stimulation, Physiotherapy, Non-immersive serious game training

Countries: Brazil

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.

Eligibility overview

Sex: ALL

Age: 20 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

São Paulo, São Paulo, Brazil