Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Pai
A Randomized, Sham-Controlled, Assessor-Blinded Study of Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Neuropathic Pain in Patients With Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Active Intermittent Theta-Burst Stimulation (iTBS)
Placebo
- Sham Intermittent Theta-Burst Stimulation
What it measured
Main measures
The Modified Tardieu Scale Quality of Muscle Reaction Score
Baseline, Week 2, and Week 4 after the final stimulation session
SpasticityWorst Lower-Limb Pain Intensity on the Numeric Rating Scale
Baseline, Week 2, and Week 4 after the final stimulation session
Pain
Other measures (12)
Neuropathic Pain Features Measured by the Douleur Neuropathique 4 Questionnaire
Baseline, Week 2, and Week 4 after the final stimulation session
PainMultiple Sclerosis Impact Scale - Physical Impact Score
Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Impact Scale - Psychological Impact Score
Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Quality of Life-54 - Physical Health Composite Score
Baseline, Week 2, and Week 4 after the final stimulation session
Quality of life (reported by participants)Multiple Sclerosis Quality of Life-54 - Mental Health Composite Score
Baseline, Week 2, and Week 4 after the final stimulation session
Quality of life (reported by participants)Fatigue Scale for Motor and Cognitive Functions Total Score
Baseline, Week 2, and Week 4 after the final stimulation session
Thinking and memoryFatigueHospital Anxiety and Depression Scale - Anxiety Subscale Score
Baseline, Week 2, and Week 4 after the final stimulation session
Mood and sleepHospital Anxiety and Depression Scale - Depression Subscale Score
Baseline, Week 2, and Week 4 after the final stimulation session
Mood and sleepMultiple Sclerosis Neuropsychological Screening Questionnaire Score
Baseline, Week 2, and Week 4 after the final stimulation session
Patient-Determined Disease Steps Score
Baseline, Week 2, and Week 4 after the final stimulation session
Walking and mobility
Who could take part
MS (type not specified) · 18 and over · EDSS 2.5 to 6.0
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Aug 2026
Main results due
Oct 2026
Finished
Oct 2026