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TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis
Sponsor: University of Sao Paulo
Summary
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.
Official title: Effects of Transcranial Magnetic Stimulation Combined With Virtual Reality, Multidisciplinary Rehabilitation, and Cardiac Autonomic Modulation in Multiple Sclerosis: A Clinical Trial
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-02-03
Completion Date
2026-09-28
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) will be applied using a circular coil over two cortical targets: the primary motor cortex (Cz) and the left dorsolateral prefrontal cortex (F3). Stimulation will be delivered at 10 Hz, at 90% of the resting motor threshold over Cz (30 trains of 50 pulses) and at 110% over F3 (40 trains of 50 pulses), with 20-second inter-train intervals. Active stimulation will be compared to sham stimulation, delivered using the same coil positioned inversely at 10% of machine output. Sessions will be conducted on 10 consecutive weekdays within each intervention phase.
Physiotherapy
Physiotherapy will consist of standardized, task-oriented training focused on balance, mobility, and lower limb function. The intervention will be delivered in a circuit-based format and includes static and dynamic balance exercises, gait training, stair negotiation (ascending and descending), squats on unstable surfaces, and lateral walking. The protocol aims to improve motor performance and functional mobility. Sessions will be conducted three times per week, following transcranial magnetic stimulation.
Non-immersive serious game training
Non-immersive serious game training will be conducted using the MoveHero system, based on webcam interaction. Participants will perform lower limb movements in response to visual stimuli, requiring coordination, timing, and motor control. Tasks involve unipodal support and goal-directed movements to interact with virtual targets, promoting motor coordination, dynamic balance, and sensorimotor integration. Sessions will be conducted three times per week, following transcranial magnetic stimulation, in conjunction with physiotherapy.
Locations (1)
ABEM - Associação Brasileira de Esclerose Múltipla
São Paulo, São Paulo, Brazil