Health TrialsbyHealthPanel

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

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorClinique Neuro-Outaouais

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: rTMS (repetitive Transcranial Magnetic Stimulation )Active comparator 1 intervention
Group B: sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement of T25FWT (Timed 25-Foot Walk Test)

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

Time frame
18 weeks

Secondary outcomes

1

6MWT (Six minute Walk Test)

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

Time frame
12 weeks
2

MSQoL (Multiple Sclerosis Quality of Life)

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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Neuro-Outaouais

Lead sponsor

University of Ottawa

Collaborator

Source ClinicalTrials.gov
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