NCT07786506Not yet recruiting
Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Pain in Multiple Sclerosis
A Randomized, Sham-Controlled, Assessor-Blinded Study of Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Neuropathic Pain in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
Spasticity and neuropathic pain are frequent and disabling symptoms of multiple sclerosis. Intermittent theta-burst stimulation (iTBS) is a non-invasive neuromodulation technique that may modulate cortical and corticospinal excitability and thereby improve motor symptoms and pain. This randomized, parallel-group, sham-controlled, assessor-blinded study will evaluate the clinical efficacy of active iTBS compared with sham stimulation in adults with multiple sclerosis and clinically significant lower-limb spasticity and pain. Participants will receive five stimulation sessions over one week. Spasticity, pain, patient-reported outcomes, and the electrophysiological H/M ratio will be assessed at baseline and at Weeks 2 and 4 after the intervention.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 10 Aug 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Comenius University
- Diseases
- Multiple sclerosis
- NCT number
- NCT07786506
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 10 Aug 2026 to the primary completion date, 31 Oct 2026
- 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
- Clinical relapse of multiple sclerosis within 30 days before enrolment.
Other illness
- Epilepsy or another condition associated with an increased risk of seizure.
- Metallic implants, implanted electronic devices, or other conditions contraindicating transcranial magnetic stimulation.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- Diagnosis of multiple sclerosis according to the 2024 McDonald criteria.
- Expanded Disability Status Scale (EDSS) score from 2.5 to 6.0.
- Clinically significant spasticity in at least one muscle group of the more affected lower limb, defined as a Modified Tardieu Scale quality of muscle reaction score of at least 2 at velocity V3.
- Lower-limb pain intensity of at least 4/10 on a 0-10 Visual Analogue Scale at screening.
- Stable pharmacological treatment, including disease-modifying therapy, for at least 3 months before enrolment.
- Ability to understand the study procedures and provide written informed consent.
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| 2nd Department of Neurology, Faculty of Medicine, Comenius University Bratislava and University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.