rTMS to improve walking in MS-related spastic paraparesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Neuro-Outaouais
  Gatineau, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Francois Jacques, Neurologist — Clinique Neuro-Outaouais
• Study coordinator: Francois Jacques, Neurologist
• Email: francois.jacques@neuro-outaouais.ca
• Phone: 819-777-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.