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

NCT07159789 | Recruiting

• 1 other identifier: CeV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

rTMS; Neuromodulation; MS Induced Spastic Paraparesis; Spastic paresis; neural synchrony; neuroplasticity

Outcome Measures

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

  18 weeks

Secondary Outcomes (2)

• 6MWT (Six minute Walk Test)

  12 weeks

• MSQoL (Multiple Sclerosis Quality of Life)

  12 weeks

Study Arms (2)

rTMS (repetitive Transcranial Magnetic Stimulation )

ACTIVE COMPARATOR

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

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

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

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

rTMS (repetitive Transcranial Magnetic Stimulation ); sham rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: collaborator
• Clinique Neuro-Outaouais: lead

Study Sites (1)

Clinique Neuro-Outaouais

Gatineau, Quebec, J8Y1W2, Canada

RECRUITING

Related Publications (11)

• 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.

  PMID: 7613530 BACKGROUND

• Thompson 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.

  PMID: 29275977 BACKGROUND

• Schoonheim 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.

  PMID: 25926813 BACKGROUND

• Rotenberg 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.

  PMID: 19747883 BACKGROUND

• Oosterveer 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.

  PMID: 34871859 BACKGROUND

• Joo 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.

  PMID: 17223384 BACKGROUND

• Goldman 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.

  PMID: 17942508 BACKGROUND

• Gandhi 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.

  PMID: 12117757 BACKGROUND

• Barkhof F. The clinico-radiological paradox in multiple sclerosis revisited. Curr Opin Neurol. 2002 Jun;15(3):239-45. doi: 10.1097/00019052-200206000-00003.

  PMID: 12045719 BACKGROUND

• Azevedo 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.

  PMID: 29328531 BACKGROUND

• Absinta 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.

  PMID: 32324705 BACKGROUND

Related Links

• Clinique Neuro-Outaouais website

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Francois Jacques, Neurologist

  Clinique Neuro-Outaouais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francois Jacques, Neurologist

CONTACT

819-777-2500; francois.jacques@neuro-outaouais.ca

Ibrahim Sangare, Nurse

CONTACT

819-777-2500; ibrahim.sangare@neuro-outaouais.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)