Multiple Sclerosis
Conditions
Keywords
rTMS, Neuromodulation, MS Induced Spastic Paraparesis, Spastic paresis, neural synchrony, neuroplasticity
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.
Interventions
DEVICERepetitive 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
Sponsors
University of Ottawa
Clinique Neuro-Outaouais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Patient will be randomized in a 1:1 ratio, into two parallel groups. Randomization will be stratified according to age, ongoing use or not of Fampridine and baseline timed 25-foot walk test (T25FWT) results
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactFrancois Jacques, Neurologist
Backup ContactIbrahim Sangare, Nurse
Outcome results
None listed