Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation

Introduction: Episodic migraine is a debilitating condition associated with vast impairments of health, daily living, and life quality. Several prophylactic treatments exist, having a moderate ratio of action related to side effects and therapy costs. Repetitive transcranial magnetic stimulation (rT...

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Autores principales: Pavel Leahu, Manuel Bange, Dumitru Ciolac, Stefanie Scheiter, Alexandru Matei, Gabriel Gonzalez-Escamilla, Venkata C. Chirumamilla, Stanislav A. Groppa, Muthuraman Muthuraman, Sergiu Groppa
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Publicado: Elsevier 2021
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spelling oai:doaj.org-article:7352aae78139471295caff9a997b83732021-11-20T05:02:50ZIncreased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation1935-861X10.1016/j.brs.2021.10.383https://doaj.org/article/7352aae78139471295caff9a997b83732021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S1935861X2100629Xhttps://doaj.org/toc/1935-861XIntroduction: Episodic migraine is a debilitating condition associated with vast impairments of health, daily living, and life quality. Several prophylactic treatments exist, having a moderate ratio of action related to side effects and therapy costs. Repetitive transcranial magnetic stimulation (rTMS) is an evidence based therapy in several neuropsychiatric conditions, showing robust efficacy in alleviating specific symptoms. However, its efficacy in migraine disorders is unequivocal and might be tightly linked to the applied rTMS protocol. We hypothesized that multifocal rTMS paradigm could improve clinical outcomes in patients with episodic migraine by reducing the number of migraine days, frequency and intensity of migraine attacks, and improve the quality of life. Methods: We conducted an experimental, double-blind, randomized controlled study by applying a multifocal rTMS paradigm. Patients with episodic migraine with or without aura were enrolled in two centers from August 2018, to December 2019, and randomized to receive either real (n = 37) or sham (sham coil stimulation, n = 28) multifocal rTMS for six sessions over two weeks. Patients, physicians, and raters were blinded to the applied protocol. The experimental multifocal rTMS protocol included two components; first, swipe stimulation of 13 trains of 140 pulses/train, 67 Hz, 60% of RMT, and 2s intertrain interval and second, spot burst stimulation of 33 trains of 15 pulses/train, 67 Hz, 85% of RMT, and 8s intertrain interval. Reduction >50% from the baseline in migraine days (as primary outcome) and frequency and intensity of migraine attacks (as key secondary outcomes) over a 12-week period were assessed. To balance the baseline variables between the treatment arms, we applied the propensity score matching through the logistic regression. Results: Among 65 randomized patients, sixty (age 39.7 ± 11.6; 52 females; real rTMS n = 33 and sham rTMS n = 27) completed the trial and five patients dropped out. Over 12 weeks, the responder's rate in the number of migraine days was significantly higher in the real rTMS compared to the sham group (42% vs. 26%, p < 0.05). The mean migraine days per month decreased from 7.6 to 4.3 days in the real rTMS group and from 6.2 to 4.3 days in the sham rTMS group, resulting in a difference with real vs. sham rTMS of −3.2 days (p < 0.05). Similarly, over the 12-week period, the responder's rate in the reduction of migraine attacks frequency was higher in the real rTMS compared to the sham group (42% vs 33%, p < 0.05). No serious adverse events were observed. Conclusion: Our pilot study shows compelling evidence in a double placebo-controlled trial that multifocal rTMS is an effective and well-tolerated preventive treatment in patients with episodic migraine.Pavel LeahuManuel BangeDumitru CiolacStefanie ScheiterAlexandru MateiGabriel Gonzalez-EscamillaVenkata C. ChirumamillaStanislav A. GroppaMuthuraman MuthuramanSergiu GroppaElsevierarticleMigraineMultifocal rTMSPreventionMigraine days50% responder RatesNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571ENBrain Stimulation, Vol 14, Iss 6, Pp 1544-1552 (2021)
institution DOAJ
collection DOAJ
language EN
topic Migraine
Multifocal rTMS
Prevention
Migraine days
50% responder Rates
Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
spellingShingle Migraine
Multifocal rTMS
Prevention
Migraine days
50% responder Rates
Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Pavel Leahu
Manuel Bange
Dumitru Ciolac
Stefanie Scheiter
Alexandru Matei
Gabriel Gonzalez-Escamilla
Venkata C. Chirumamilla
Stanislav A. Groppa
Muthuraman Muthuraman
Sergiu Groppa
Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
description Introduction: Episodic migraine is a debilitating condition associated with vast impairments of health, daily living, and life quality. Several prophylactic treatments exist, having a moderate ratio of action related to side effects and therapy costs. Repetitive transcranial magnetic stimulation (rTMS) is an evidence based therapy in several neuropsychiatric conditions, showing robust efficacy in alleviating specific symptoms. However, its efficacy in migraine disorders is unequivocal and might be tightly linked to the applied rTMS protocol. We hypothesized that multifocal rTMS paradigm could improve clinical outcomes in patients with episodic migraine by reducing the number of migraine days, frequency and intensity of migraine attacks, and improve the quality of life. Methods: We conducted an experimental, double-blind, randomized controlled study by applying a multifocal rTMS paradigm. Patients with episodic migraine with or without aura were enrolled in two centers from August 2018, to December 2019, and randomized to receive either real (n = 37) or sham (sham coil stimulation, n = 28) multifocal rTMS for six sessions over two weeks. Patients, physicians, and raters were blinded to the applied protocol. The experimental multifocal rTMS protocol included two components; first, swipe stimulation of 13 trains of 140 pulses/train, 67 Hz, 60% of RMT, and 2s intertrain interval and second, spot burst stimulation of 33 trains of 15 pulses/train, 67 Hz, 85% of RMT, and 8s intertrain interval. Reduction >50% from the baseline in migraine days (as primary outcome) and frequency and intensity of migraine attacks (as key secondary outcomes) over a 12-week period were assessed. To balance the baseline variables between the treatment arms, we applied the propensity score matching through the logistic regression. Results: Among 65 randomized patients, sixty (age 39.7 ± 11.6; 52 females; real rTMS n = 33 and sham rTMS n = 27) completed the trial and five patients dropped out. Over 12 weeks, the responder's rate in the number of migraine days was significantly higher in the real rTMS compared to the sham group (42% vs. 26%, p < 0.05). The mean migraine days per month decreased from 7.6 to 4.3 days in the real rTMS group and from 6.2 to 4.3 days in the sham rTMS group, resulting in a difference with real vs. sham rTMS of −3.2 days (p < 0.05). Similarly, over the 12-week period, the responder's rate in the reduction of migraine attacks frequency was higher in the real rTMS compared to the sham group (42% vs 33%, p < 0.05). No serious adverse events were observed. Conclusion: Our pilot study shows compelling evidence in a double placebo-controlled trial that multifocal rTMS is an effective and well-tolerated preventive treatment in patients with episodic migraine.
format article
author Pavel Leahu
Manuel Bange
Dumitru Ciolac
Stefanie Scheiter
Alexandru Matei
Gabriel Gonzalez-Escamilla
Venkata C. Chirumamilla
Stanislav A. Groppa
Muthuraman Muthuraman
Sergiu Groppa
author_facet Pavel Leahu
Manuel Bange
Dumitru Ciolac
Stefanie Scheiter
Alexandru Matei
Gabriel Gonzalez-Escamilla
Venkata C. Chirumamilla
Stanislav A. Groppa
Muthuraman Muthuraman
Sergiu Groppa
author_sort Pavel Leahu
title Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
title_short Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
title_full Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
title_fullStr Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
title_full_unstemmed Increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
title_sort increased migraine-free intervals with multifocal repetitive transcranial magnetic stimulation
publisher Elsevier
publishDate 2021
url https://doaj.org/article/7352aae78139471295caff9a997b8373
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