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Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Pain in Multiple Sclerosis

Not Yet RecruitingNA

Sponsor: Comenius University

Conditions: Multiple Sclerosis, Muscle Spasticity, Neuropathic Pain

Interventions: Active Intermittent Theta-Burst Stimulation (iTBS), Sham Intermittent Theta-Burst Stimulation

Countries: Slovakia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Epilepsy or another condition associated with an increased risk of seizure.
* Metallic implants, implanted electronic devices, or other conditions contraindicating transcranial magnetic stimulation.
* Clinical relapse of multiple sclerosis within 30 days before enrolment.
* Pregnancy or breastfeeding.

Locations (1)

Bratislava, Slovakia