Multiple SclerosisCeVNCT07159789
Repetitive Transcranial Magnetic Stimulation (rTMS) in MS Induced Spastic Paraparesis
A study testing Repetitive Transcranial Magnetic Stimulation in people with Multiple Sclerosis, run by Clinique Neuro-Outaouais at 1 site in Canada.
Trial summary
Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2025to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Clinique Neuro-Outaouais
Gatineau, Quebec, J8Y1W2
Ibrahim Sangare, Nurse, 819-777-2500 ext. 252, Ibrahim.sangare@neuro-outaouais.ca
Victorine Sikati Foko, Nurse, 819-777-2500 ext. 211, victorine.sikatifoko@neuro-outaouais.ca
About this study
Official title: Non-Invasive Neuromodulation 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS, Neuromodulation, MS Induced Spastic Paraparesis, Spastic paresis, neural synchrony, neuroplasticity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| rTMS (repetitive Transcranial Magnetic Stimulation ) | Active comparator | rTMS will use 100% magnetic pulses to stimulate specific areas of the brain Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| sham rTMS | Sham comparator | Sham rTMS will be conducted using the same DCC coil and MagStim machine but using only 10% of maximum machine output as stimulation intensity Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (2)
6MWT (Six minute Walk Test)
Patients who achieve an improvement of 30 meters or more in their baseline six Minute Walk Test (6MWT)
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Neuro-Outaouais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Francois Jacques, Neurologist, Principal investigator, Clinique Neuro-Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159789
- Sponsor's protocol ID
- CeV
- Acronym
- CeV
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.
PubMed 7613530Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
PubMed 29275977Schoonheim MM, Meijer KA, Geurts JJ. Network collapse and cognitive impairment in multiple sclerosis. Front Neurol. 2015 Apr 14;6:82. doi: 10.3389/fneur.2015.00082. eCollection 2015. No abstract available.
PubMed 25926813Rotenberg A, Bae EH, Muller PA, Riviello JJ Jr, Bourgeois BF, Blum AS, Pascual-Leone A. In-session seizures during low-frequency repetitive transcranial magnetic stimulation in patients with epilepsy. Epilepsy Behav. 2009 Oct;16(2):353-5. doi: 10.1016/j.yebeh.2009.08.010. Epub 2009 Sep 10.
PubMed 19747883Oosterveer DM, van den Berg C, Volker G, Wouda NC, Terluin B, Hoitsma E. Determining the minimal important change of the 6-minute walking test in Multiple Sclerosis patients using a predictive modelling anchor-based method. Mult Scler Relat Disord. 2022 Jan;57:103438. doi: 10.1016/j.msard.2021.103438. Epub 2021 Nov 30.
PubMed 34871859Joo EY, Han SJ, Chung SH, Cho JW, Seo DW, Hong SB. Antiepileptic effects of low-frequency repetitive transcranial magnetic stimulation by different stimulation durations and locations. Clin Neurophysiol. 2007 Mar;118(3):702-8. doi: 10.1016/j.clinph.2006.11.008. Epub 2007 Jan 16.
PubMed 17223384Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. doi: 10.1177/1352458507082607. Epub 2007 Oct 17.
PubMed 17942508Gandhi OP. Electromagnetic fields: human safety issues. Annu Rev Biomed Eng. 2002;4:211-34. doi: 10.1146/annurev.bioeng.4.020702.153447. Epub 2002 Mar 22.
PubMed 12117757Barkhof F. The clinico-radiological paradox in multiple sclerosis revisited. Curr Opin Neurol. 2002 Jun;15(3):239-45. doi: 10.1097/00019052-200206000-00003.
PubMed 12045719Azevedo CJ, Cen SY, Khadka S, Liu S, Kornak J, Shi Y, Zheng L, Hauser SL, Pelletier D. Thalamic atrophy in multiple sclerosis: A magnetic resonance imaging marker of neurodegeneration throughout disease. Ann Neurol. 2018 Feb;83(2):223-234. doi: 10.1002/ana.25150. Epub 2018 Feb 9.
PubMed 29328531Absinta M, Lassmann H, Trapp BD. Mechanisms underlying progression in multiple sclerosis. Curr Opin Neurol. 2020 Jun;33(3):277-285. doi: 10.1097/WCO.0000000000000818.
PubMed 32324705