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

Clinique Neuro-Outaouais

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07159789

CeV

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

rTMS (repetitive Transcranial Magnetic Stimulation )

Active Comparator group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

sham rTMS

Sham Comparator group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation