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NCT Number: NCT07159789

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Neuro-Outaouais

Gatineau, Quebec, J8Y1W2, Canada

Location status: Recruiting

Location contact

Francois Jacques, Neurologist

PRINCIPAL_INVESTIGATOR

Ibrahim Sangare, Registered Nurse

CONTACT

[email protected]

819-777-2500 ext. 252

Victorine Sikati Foko, Registered Nurse

CONTACT

[email protected]

819-777-2500 ext. 211

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent.
  • Age ≥ 18 years and less than 71 years.
  • Diagnosis of MS according to the revised 2017 McDonald Criteria (Thompson et al. 2018).
  • EDSS of 3.0 to 6.5 with a pyramidal functional system score of 3.0 or more.
  • Neurologically stable with no change in symptom related medications or relapse for at least 30 days prior to screening.
  • 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.
  • No change in disease modifying therapy for at least 3 months prior to screening.
  • Ability to perform T25FWT, the MSQoL 6MWT Ability and willingness, in the investigator's opinion, to comply with the study protocol.

Exclusion criteria

  • 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.
  • 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.
  • Pregnant or breastfeeding or intending to become pregnant during the study.
  • Any previous rTMS therapy for any indication.
  • Presence of any contraindication to rTMS therapy such as but not limited to: CNS implanted devices, pacemaker.
  • Any condition which in the opinion of the investigator will render the patient unsuitable to participate in the study.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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 outcomes

  1. Improvement of T25FWT (Timed 25-Foot Walk Test)

    Time frame: 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 outcomes

  1. 6MWT (Six minute Walk Test)

    Time frame: 12 weeks

    Patients who achieve an improvement of 30 meters or more in their baseline six Minute Walk Test (6MWT)

  2. MSQoL (Multiple Sclerosis Quality of Life)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Francois Jacques, Neurologist

CONTACT

[email protected]

819-777-2500

Ibrahim Sangare, Nurse

CONTACT

[email protected]

819-777-2500 ext. 252

Sponsors and collaborators

Lead sponsor

Clinique Neuro-Outaouais

Other

Collaborators

  • University of Ottawa

Registry information

Official study title

Non-Invasive Neuromodulation in MS Induced Spastic Paraparesis

Acronym: CeV

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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