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| Name | Class |
|---|---|
| University of Ottawa | OTHER |
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Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS (repetitive Transcranial Magnetic Stimulation ) | Active Comparator | rTMS will use 100% magnetic pulses to stimulate specific areas of the brain |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6MWT (Six minute Walk Test) | Patients who achieve an improvement of 30 meters or more in their baseline six Minute Walk Test (6MWT) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francois Jacques, Neurologist | Contact | 819-777-2500 | francois.jacques@neuro-outaouais.ca | |
| Ibrahim Sangare, Nurse | Contact | 819-777-2500 | 252 | ibrahim.sangare@neuro-outaouais.ca |
| Name | Affiliation | Role |
|---|---|---|
| Francois Jacques, Neurologist | Clinique Neuro-Outaouais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Neuro-Outaouais | Recruiting | Gatineau | Quebec | J8Y1W2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7613530 | Background | 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. | |
| 29275977 | 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. |
| Label | URL |
|---|---|
| Clinique Neuro-Outaouais website | View source |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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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
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|
| 12 weeks |
| 25926813 | 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. |
| 19747883 | 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. |
| 34871859 | 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. |
| 17223384 | 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. |
| 17942508 | 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. |
| 12117757 | 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. |
| 12045719 | 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. |
| 29328531 | 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. |
| 32324705 | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |