Repetitive Transcranial Magnetic Stimulation (rTMS) in MS Induced Spastic Paraparesis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07159789
• Lead Sponsor: Clinique Neuro-Outaouais

Brief Summary

Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.

Detailed Description

Measure the impact of rTMS on overall disability level, walking endurance, quality of life parameters, and corroborate with EEG parameters of neural synchrony in patients with MS.

Study Timeline

• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Status Verified: 2025-09
• Study First Posted: 2025-09-08
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-12
• Study Start: 2025-10-01
• Primary Completion: 2027-10
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of T25FWT (Timed 25-Foot Walk Test)	18 weeks	The difference in the number of patients who achieved an improvement of 20% or more from their baseline T25FWT between those that received 6 weeks of sham rTMS and those that received 6 weeks of rTMS

Secondary Outcome Measures

Name	Time	Method
6MWT (Six minute Walk Test)	12 weeks	Patients who achieve an improvement of 30 meters or more in their baseline six Minute Walk Test (6MWT)
MSQoL (Multiple Sclerosis Quality of Life)	12 weeks	The change from baseline in MSQoL group mean scores between those that received 6 weeks of sham rTMS and those that received 6 weeks of rTMS

Trial Locations

Locations (1)

Clinique Neuro-Outaouais; 🇨🇦 Gatineau, Quebec, Canada