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A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

OBJECTIVE: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. BACKGROUND: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. T...

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Autores principales: Starling, Amaal J, Tepper, Stewart J, Marmura, Michael J, Shamim, Ejaz A, Robbins, Matthew S, Hindiyeh, Nada, Charles, Andrew C, Goadsby, Peter J, Lipton, Richard B, Silberstein, Stephen D, Gelfand, Amy A, Chiacchierini, Richard P, Dodick, David W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5944078/
https://www.ncbi.nlm.nih.gov/pubmed/29504483
http://dx.doi.org/10.1177/0333102418762525
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author Starling, Amaal J
Tepper, Stewart J
Marmura, Michael J
Shamim, Ejaz A
Robbins, Matthew S
Hindiyeh, Nada
Charles, Andrew C
Goadsby, Peter J
Lipton, Richard B
Silberstein, Stephen D
Gelfand, Amy A
Chiacchierini, Richard P
Dodick, David W
author_facet Starling, Amaal J
Tepper, Stewart J
Marmura, Michael J
Shamim, Ejaz A
Robbins, Matthew S
Hindiyeh, Nada
Charles, Andrew C
Goadsby, Peter J
Lipton, Richard B
Silberstein, Stephen D
Gelfand, Amy A
Chiacchierini, Richard P
Dodick, David W
author_sort Starling, Amaal J
collection PubMed
description OBJECTIVE: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. BACKGROUND: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. METHODS: The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. RESULTS: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher (p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. CONCLUSIONS: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. TRIAL REGISTRATION NUMBER: NCT02357381
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spelling pubmed-59440782018-05-18 A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study) Starling, Amaal J Tepper, Stewart J Marmura, Michael J Shamim, Ejaz A Robbins, Matthew S Hindiyeh, Nada Charles, Andrew C Goadsby, Peter J Lipton, Richard B Silberstein, Stephen D Gelfand, Amy A Chiacchierini, Richard P Dodick, David W Cephalalgia Original Articles OBJECTIVE: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. BACKGROUND: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. METHODS: The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. RESULTS: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher (p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. CONCLUSIONS: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. TRIAL REGISTRATION NUMBER: NCT02357381 SAGE Publications 2018-03-04 2018-05 /pmc/articles/PMC5944078/ /pubmed/29504483 http://dx.doi.org/10.1177/0333102418762525 Text en © International Headache Society 2018 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Articles
Starling, Amaal J
Tepper, Stewart J
Marmura, Michael J
Shamim, Ejaz A
Robbins, Matthew S
Hindiyeh, Nada
Charles, Andrew C
Goadsby, Peter J
Lipton, Richard B
Silberstein, Stephen D
Gelfand, Amy A
Chiacchierini, Richard P
Dodick, David W
A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)
title A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)
title_full A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)
title_fullStr A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)
title_full_unstemmed A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)
title_short A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)
title_sort multicenter, prospective, single arm, open label, observational study of stms for migraine prevention (espouse study)
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5944078/
https://www.ncbi.nlm.nih.gov/pubmed/29504483
http://dx.doi.org/10.1177/0333102418762525
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