NCT07593807Active, not recruiting
TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis
Effects of Transcranial Magnetic Stimulation Combined With Virtual Reality, Multidisciplinary Rehabilitation, and Cardiac Autonomic Modulation in Multiple Sclerosis: A Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- 3 Feb 2025
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- University of Sao Paulo
- Diseases
- Multiple sclerosis
- NCT number
- NCT07593807
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 3 Feb 2025 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of metallic implants in the skull, cranial deformities, or absence of cranial vault.
- Use of medications that significantly interfere with autonomic nervous system function, such as antiarrhythmic drugs or insulin.
Other illness
- Cardiac arrhythmias or atrioventricular block.
- Congenital abnormalities, including congenital heart disease or pulmonary malformations.
- History of seizures.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ABEM - Associação Brasileira de Esclerose Múltipla Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.