Phuong Tram Nguyen, Amin Zarghami, Kalina Makowiecki, Natasha Stevens, Chigozie Ezegbe, Kain Kyle, Chenyu Wang, Linda Ly, Katie De La Rue, Mark R Hinder, Lewis Johnson, Jennifer Rodger, Samantha Cooper, Carlie L Cullen, Michael Barnett, Kaylene M Young, Bruce V Taylor
{"title":"低强度重复经颅磁刺激对多发性硬化症患者安全且耐受性良好--第一阶段随机对照试验（TAURUS）的结果。","authors":"Phuong Tram Nguyen, Amin Zarghami, Kalina Makowiecki, Natasha Stevens, Chigozie Ezegbe, Kain Kyle, Chenyu Wang, Linda Ly, Katie De La Rue, Mark R Hinder, Lewis Johnson, Jennifer Rodger, Samantha Cooper, Carlie L Cullen, Michael Barnett, Kaylene M Young, Bruce V Taylor","doi":"10.1177/20552173241252571","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Low-intensity repetitive transcranial magnetic stimulation (rTMS), delivered as a daily intermittent theta burst stimulation (iTBS) for four consecutive weeks, increased the number of new oligodendrocytes in the adult mouse brain. Therefore, rTMS holds potential as a remyelinating intervention for people with multiple sclerosis (MS).</p><p><strong>Objective: </strong>Primarily to determine the safety and tolerability of our rTMS protocol in people with MS. Secondary objectives include feasibility, blinding and an exploration of changes in magnetic resonance imaging (MRI) metrics, patient-reported outcome measures (PROMs) and cognitive or motor performance.</p><p><strong>Methods: </strong>A randomised (2:1), placebo controlled, single blind, parallel group, phase 1 trial of 20 rTMS sessions (600 iTBS pulses per hemisphere; 25% maximum stimulator output), delivered over 4-5 weeks. Twenty participants were randomly assigned to 'sham' (<i>n</i> = 7) or active rTMS (<i>n</i> = 13), with the coil positioned at 90° or 0°, respectively.</p><p><strong>Results: </strong>Five adverse events (AEs) including one serious AE reported. None were related to treatment. Protocol compliance was high (85%) and blinding successful. Within participant MRI metrics, PROMs and cognitive or motor performance were unchanged over time.</p><p><strong>Conclusion: </strong>Twenty sessions of rTMS is safe and well tolerated in a small group of people with MS. The study protocol and procedures are feasible. Improvement of sham is warranted before further investigating safety and efficacy.</p>","PeriodicalId":18961,"journal":{"name":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","volume":"10 2","pages":"20552173241252571"},"PeriodicalIF":2.5000,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097717/pdf/","citationCount":"0","resultStr":"{\"title\":\"Low-intensity repetitive transcranial magnetic stimulation is safe and well tolerated by people living with MS - outcomes of the phase I randomised controlled trial (TAURUS).\",\"authors\":\"Phuong Tram Nguyen, Amin Zarghami, Kalina Makowiecki, Natasha Stevens, Chigozie Ezegbe, Kain Kyle, Chenyu Wang, Linda Ly, Katie De La Rue, Mark R Hinder, Lewis Johnson, Jennifer Rodger, Samantha Cooper, Carlie L Cullen, Michael Barnett, Kaylene M Young, Bruce V Taylor\",\"doi\":\"10.1177/20552173241252571\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Low-intensity repetitive transcranial magnetic stimulation (rTMS), delivered as a daily intermittent theta burst stimulation (iTBS) for four consecutive weeks, increased the number of new oligodendrocytes in the adult mouse brain. Therefore, rTMS holds potential as a remyelinating intervention for people with multiple sclerosis (MS).</p><p><strong>Objective: </strong>Primarily to determine the safety and tolerability of our rTMS protocol in people with MS. Secondary objectives include feasibility, blinding and an exploration of changes in magnetic resonance imaging (MRI) metrics, patient-reported outcome measures (PROMs) and cognitive or motor performance.</p><p><strong>Methods: </strong>A randomised (2:1), placebo controlled, single blind, parallel group, phase 1 trial of 20 rTMS sessions (600 iTBS pulses per hemisphere; 25% maximum stimulator output), delivered over 4-5 weeks. Twenty participants were randomly assigned to 'sham' (<i>n</i> = 7) or active rTMS (<i>n</i> = 13), with the coil positioned at 90° or 0°, respectively.</p><p><strong>Results: </strong>Five adverse events (AEs) including one serious AE reported. None were related to treatment. Protocol compliance was high (85%) and blinding successful. Within participant MRI metrics, PROMs and cognitive or motor performance were unchanged over time.</p><p><strong>Conclusion: </strong>Twenty sessions of rTMS is safe and well tolerated in a small group of people with MS. The study protocol and procedures are feasible. Improvement of sham is warranted before further investigating safety and efficacy.</p>\",\"PeriodicalId\":18961,\"journal\":{\"name\":\"Multiple Sclerosis Journal - Experimental, Translational and Clinical\",\"volume\":\"10 2\",\"pages\":\"20552173241252571\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-05-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097717/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Multiple Sclerosis Journal - Experimental, Translational and Clinical\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/20552173241252571\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/4/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20552173241252571","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/4/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Low-intensity repetitive transcranial magnetic stimulation is safe and well tolerated by people living with MS - outcomes of the phase I randomised controlled trial (TAURUS).
Background: Low-intensity repetitive transcranial magnetic stimulation (rTMS), delivered as a daily intermittent theta burst stimulation (iTBS) for four consecutive weeks, increased the number of new oligodendrocytes in the adult mouse brain. Therefore, rTMS holds potential as a remyelinating intervention for people with multiple sclerosis (MS).
Objective: Primarily to determine the safety and tolerability of our rTMS protocol in people with MS. Secondary objectives include feasibility, blinding and an exploration of changes in magnetic resonance imaging (MRI) metrics, patient-reported outcome measures (PROMs) and cognitive or motor performance.
Methods: A randomised (2:1), placebo controlled, single blind, parallel group, phase 1 trial of 20 rTMS sessions (600 iTBS pulses per hemisphere; 25% maximum stimulator output), delivered over 4-5 weeks. Twenty participants were randomly assigned to 'sham' (n = 7) or active rTMS (n = 13), with the coil positioned at 90° or 0°, respectively.
Results: Five adverse events (AEs) including one serious AE reported. None were related to treatment. Protocol compliance was high (85%) and blinding successful. Within participant MRI metrics, PROMs and cognitive or motor performance were unchanged over time.
Conclusion: Twenty sessions of rTMS is safe and well tolerated in a small group of people with MS. The study protocol and procedures are feasible. Improvement of sham is warranted before further investigating safety and efficacy.
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