Recruiting

rTMS

Sponsor:

Clinique Neuro-Outaouais

Code:

NCT07159789

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation

Study Details

Brief summary:

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

Conditions

Multiple Sclerosis

Study ID

NCT07159789

Start date

Oct 15, 2025

Status verified date

Dec, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: rTMS (repetitive Transcranial Magnetic Stimulation )

rTMS will use 100% magnetic pulses to stimulate specific areas of the brain

sham comparator: sham rTMS

Sham rTMS will be conducted using the same DCC coil and MagStim machine but using only 10% of maximum machine output as stimulation intensity

Interventions

Repetitive Transcranial Magnetic Stimulation

Treatment with the rTMS or sham rTMS will be scheduled daily 5x per week for a total of 6 consecutive weeks followed, after a 6 week pause, by another treatment session of 6 weeks where all patients will receive active rTMS treatment

Primary outcome measure

  • Improvement of T25FWT (Timed 25-Foot Walk Test) [ Time Frame: 18 weeks ]

Central Contacts and Locations

Central contacts

Locations

Clinique Neuro-Outaouais

Recruiting

Gatineau, Quebec, Canada, J8Y1W2

Contacts

Ibrahim Sangare, Registered Nurse

819-777-2500Ibrahim.sangare@neuro-outaouais.ca

Victorine Sikati Foko, Registered Nurse

819-777-2500victorine.sikatifoko@neuro-outaouais.ca

Principal Investigator:

Francois Jacques, Neurologist

More Information

Sponsor

Clinique Neuro-Outaouais

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Keywords

  • rTMS
  • Neuromodulation
  • MS Induced Spastic Paraparesis
  • Spastic paresis
  • neural synchrony
  • neuroplasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clinique Neuro-Outaouais on 2025-12-04.