A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving

<h4>Background</h4> Cocaine use disorder (CUD) is a global health issue with no effective treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) is a recently proposed therapy for CUD. <h4>Methods</h4> We conducted a single-center, randomised, sham-controlled, blinded...

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Autores principales:	Francesco Lolli, Maya Salimova, Maenia Scarpino, Giovanni Lanzo, Cesarina Cossu, Maria Bastianelli, Brunella Occupati, Filippo Gori, Amedeo Del Vecchio, Anita Ercolini, Silvia Pascolo, Virginia Cimino, Nicolò Meneghin, Fabio Fierini, Giulio D’Anna, Matteo Innocenti, Andrea Ballerini, Stefano Pallanti, Antonello Grippo, Guido Mannaioni
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/489a6250f8854a1fa46fa8f532ffc7c8
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spelling	oai:doaj.org-article:489a6250f8854a1fa46fa8f532ffc7c82021-11-25T06:10:51ZA randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving1932-6203https://doaj.org/article/489a6250f8854a1fa46fa8f532ffc7c82021-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8594832/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4> Cocaine use disorder (CUD) is a global health issue with no effective treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) is a recently proposed therapy for CUD. <h4>Methods</h4> We conducted a single-center, randomised, sham-controlled, blinded, parallel-group research with patients randomly allocated to rTMS (15 Hz) or Sham group (1:1) using a computerised block randomisation process. We enrolled 62 of 81 CUD patients in two years. Patients were followed for eight weeks after receiving 15 15 Hz rTMS/sham sessions over the left dorsolateral prefrontal cortex (DLPFC) during the first three weeks of the study. We targeted the DLFPC following the 5 cm method. Cocaine lapses in twice a week urine tests were the primary outcome. The secondary outcomes were craving severity, cocaine use pattern, and psychometric assessments. <h4>Findings</h4> We randomly allocated patients to either an active rTMS group (32 subjects) or a sham treatment group (30 subjects). Thirteen (42%) and twelve (43.3%) of the subjects in rTMS and sham groups, respectively, completed the full trial regimen, displaying a high dropout rate. Ten/30 (33%) of rTMS-treated patients tested negative for cocaine in urine, in contrast to 4/27 of placebo controls (p = 0.18, odd ratio 2.88, CI 0.9–10). The Kaplan-Meier survival curve did not state a significant change between the treated and sham groups in the time of cocaine urine negativisation (p = 0.20). However, the severity of cocaine-related cues mediated craving (VAS peak) was substantially decreased in the rTMS treated group (p<0.03) after treatment at T1, corresponding to the end of rTMS treatment. Furthermore, in the rTMS and sham groups, self-reported days of cocaine use decreased significantly (p<0.03). Finally, psychometric impulsivity parameters improved in rTMS-treated patients, while depression scales improved in both groups. <h4>Conclusions</h4> In CUD, rTMS could be a useful tool for lowering cocaine craving and consumption. <h4>Trial registration</h4> The study number on clinicalTrials.gov is NCT03607591.Francesco LolliMaya SalimovaMaenia ScarpinoGiovanni LanzoCesarina CossuMaria BastianelliBrunella OccupatiFilippo GoriAmedeo Del VecchioAnita ErcoliniSilvia PascoloVirginia CiminoNicolò MeneghinFabio FieriniGiulio D’AnnaMatteo InnocentiAndrea BalleriniStefano PallantiAntonello GrippoGuido MannaioniPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Francesco Lolli Maya Salimova Maenia Scarpino Giovanni Lanzo Cesarina Cossu Maria Bastianelli Brunella Occupati Filippo Gori Amedeo Del Vecchio Anita Ercolini Silvia Pascolo Virginia Cimino Nicolò Meneghin Fabio Fierini Giulio D’Anna Matteo Innocenti Andrea Ballerini Stefano Pallanti Antonello Grippo Guido Mannaioni A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
description	<h4>Background</h4> Cocaine use disorder (CUD) is a global health issue with no effective treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) is a recently proposed therapy for CUD. <h4>Methods</h4> We conducted a single-center, randomised, sham-controlled, blinded, parallel-group research with patients randomly allocated to rTMS (15 Hz) or Sham group (1:1) using a computerised block randomisation process. We enrolled 62 of 81 CUD patients in two years. Patients were followed for eight weeks after receiving 15 15 Hz rTMS/sham sessions over the left dorsolateral prefrontal cortex (DLPFC) during the first three weeks of the study. We targeted the DLFPC following the 5 cm method. Cocaine lapses in twice a week urine tests were the primary outcome. The secondary outcomes were craving severity, cocaine use pattern, and psychometric assessments. <h4>Findings</h4> We randomly allocated patients to either an active rTMS group (32 subjects) or a sham treatment group (30 subjects). Thirteen (42%) and twelve (43.3%) of the subjects in rTMS and sham groups, respectively, completed the full trial regimen, displaying a high dropout rate. Ten/30 (33%) of rTMS-treated patients tested negative for cocaine in urine, in contrast to 4/27 of placebo controls (p = 0.18, odd ratio 2.88, CI 0.9–10). The Kaplan-Meier survival curve did not state a significant change between the treated and sham groups in the time of cocaine urine negativisation (p = 0.20). However, the severity of cocaine-related cues mediated craving (VAS peak) was substantially decreased in the rTMS treated group (p<0.03) after treatment at T1, corresponding to the end of rTMS treatment. Furthermore, in the rTMS and sham groups, self-reported days of cocaine use decreased significantly (p<0.03). Finally, psychometric impulsivity parameters improved in rTMS-treated patients, while depression scales improved in both groups. <h4>Conclusions</h4> In CUD, rTMS could be a useful tool for lowering cocaine craving and consumption. <h4>Trial registration</h4> The study number on clinicalTrials.gov is NCT03607591.
format	article
author	Francesco Lolli Maya Salimova Maenia Scarpino Giovanni Lanzo Cesarina Cossu Maria Bastianelli Brunella Occupati Filippo Gori Amedeo Del Vecchio Anita Ercolini Silvia Pascolo Virginia Cimino Nicolò Meneghin Fabio Fierini Giulio D’Anna Matteo Innocenti Andrea Ballerini Stefano Pallanti Antonello Grippo Guido Mannaioni
author_facet	Francesco Lolli Maya Salimova Maenia Scarpino Giovanni Lanzo Cesarina Cossu Maria Bastianelli Brunella Occupati Filippo Gori Amedeo Del Vecchio Anita Ercolini Silvia Pascolo Virginia Cimino Nicolò Meneghin Fabio Fierini Giulio D’Anna Matteo Innocenti Andrea Ballerini Stefano Pallanti Antonello Grippo Guido Mannaioni
author_sort	Francesco Lolli
title	A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
title_short	A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
title_full	A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
title_fullStr	A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
title_full_unstemmed	A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
title_sort	randomised, double-blind, sham-controlled study of left prefrontal cortex 15 hz repetitive transcranial magnetic stimulation in cocaine consumption and craving
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/489a6250f8854a1fa46fa8f532ffc7c8
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A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving

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