rTMS to improve walking in MS-related spastic paraparesis

Non-Invasive Neuromodulation in MS Induced Spastic Paraparesis

The trial will try repetitive transcranial magnetic stimulation (rTMS) to see if it helps adults with MS-related spastic paraparesis walk better, increase walking endurance, and improve quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Clinique Neuro-Outaouais (Academic / other)
• Locations: 1 site (Gatineau, Quebec)
• Trial ID: NCT07159789 on ClinicalTrials.gov

What this trial studies

This interventional study delivers repeated sessions of rTMS to adults with MS who have spastic paraparesis and moderate walking disability and measures clinical and functional outcomes before and after treatment. Primary and secondary measures include disability scores (EDSS), timed walking tests such as the T25-Foot Walk and walking endurance tests, and patient-reported quality-of-life measures. Resting and task-related EEG recordings will be used to examine neural synchrony and to correlate electrophysiologic changes with clinical response. Participants must be neurologically stable with no recent medication changes and will receive all treatments in person at the study site.

Who should consider this trial

Good fit: Adults aged 18–70 with MS by the 2017 McDonald criteria, EDSS 3.0–6.5 with a pyramidal score ≥3, neurologically stable for ≥30 days, able to perform timed walking tests, and without recent changes in disease-modifying or spasticity treatments are ideal candidates.

Not a fit: Patients with other neurologic disorders, recent relapse or medication changes, recent botulinum toxin or new symptomatic spasticity drugs, inability to perform walking tests, or EDSS outside the 3.0–6.5 range are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, rTMS could improve walking ability, reduce spasticity-related impairment, and enhance daily functioning and quality of life for people with MS-related spastic paraparesis.

How similar studies have performed: Small pilot studies and case series have suggested rTMS can reduce spasticity and modestly improve motor function in MS, but evidence is limited and links to EEG measures of neural synchrony remain exploratory.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent.
2. Age ≥ 18 years and less than 71 years.
3. Diagnosis of MS according to the revised 2017 McDonald Criteria (Thompson et al. 2018).
4. EDSS of 3.0 to 6.5 with a pyramidal functional system score of 3.0 or more.
5. Neurologically stable with no change in symptom related medications or relapse for at least 30 days prior to screening.
6. Patients will be allowed to continue fampridine provided they started more than 30 days prior to screening. They will not be allowed to start fampridine, any stimulant (modafenil, methylphenidate etc) or symptomatic treatment of spasticity (baclofen, tizanidine, botulinum toxin etc.) during the study.
7. No change in disease modifying therapy for at least 3 months prior to screening.
8. Ability to perform T25FWT, the MSQoL 6MWT Ability and willingness, in the investigator's opinion, to comply with the study protocol.

Exclusion Criteria:

1. Know presence of other neurologic disorders, which in the opinion of the investigator could add to the patient's neurological disability within the timespan of the study.
2. Evidence of clinically significant cardiovascular (including arrhythmias), psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the investigator's opinion, would preclude patient participation.
3. Pregnant or breastfeeding or intending to become pregnant during the study.
4. Any previous rTMS therapy for any indication.
5. Presence of any contraindication to rTMS therapy such as but not limited to: CNS implanted devices, pacemaker.
6. Any condition which in the opinion of the investigator will render the patient unsuitable to participate in the study.

Where this trial is running

Gatineau, Quebec

• Clinique Neuro-Outaouais — Gatineau, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Francois Jacques, Neurologist — Clinique Neuro-Outaouais
• Study coordinator: Francois Jacques, Neurologist

Conditions Multiple Sclerosis; rTMS; Neuromodulation; MS Induced Spastic Paraparesis; Spastic paresis; neural synchrony; neuroplasticity