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Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study

Background: Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson's Disease (PD) have shown promising results. Objective: To evaluate safety and efficacy of high-frequency rTMS with H-coil in PD in a double-blind, placebo-con...

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Autores principales: Spagnolo, Francesca, Fichera, Mario, Chieffo, Raffaella, Dalla Costa, Gloria, Pisa, Marco, Volonté, Maria Antonietta, Falautano, Monica, Zangen, Abraham, Comi, Giancarlo, Leocani, Letizia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930321/
https://www.ncbi.nlm.nih.gov/pubmed/33679570
http://dx.doi.org/10.3389/fneur.2020.584713
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author Spagnolo, Francesca
Fichera, Mario
Chieffo, Raffaella
Dalla Costa, Gloria
Pisa, Marco
Volonté, Maria Antonietta
Falautano, Monica
Zangen, Abraham
Comi, Giancarlo
Leocani, Letizia
author_facet Spagnolo, Francesca
Fichera, Mario
Chieffo, Raffaella
Dalla Costa, Gloria
Pisa, Marco
Volonté, Maria Antonietta
Falautano, Monica
Zangen, Abraham
Comi, Giancarlo
Leocani, Letizia
author_sort Spagnolo, Francesca
collection PubMed
description Background: Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson's Disease (PD) have shown promising results. Objective: To evaluate safety and efficacy of high-frequency rTMS with H-coil in PD in a double-blind, placebo-controlled, randomized study. Methods: Sixty patients with PD were randomized into 3 groups: M1-PFC (real stimulation on primary motor-M1 and pre-frontal cortices-PFC), M1 (real rTMS on M1, sham on PFC), Sham (apparent stimulation). Primary outcome was baseline-normalized percent improvement in UPDRS part III OFF-therapy at the end of treatment (12 rTMS sessions, 4 weeks). Secondary outcomes were improvement in UPDRS part III sub-scores, timed tests, and neuropsychological tests. Statistical analysis compared improvement following real and sham stimulation at the end of the protocol using either a t-test or a Mann-Whitney test. Results: All patients tolerated the treatment and concluded the study. One patient from M1-PFC group was excluded from the analysis due to newly discovered uncontrolled diabetes mellitus. No serious adverse effect was recorded. At the end of treatment, patients receiving real rTMS (M1-PFC and M1 combined) showed significantly greater improvement compared to sham in UPDRS part III total score (p = 0.007), tremor subscore (p = 0.011), and lateralized sub-scores (p = 0.042 for the more affected side; p = 0.012 for the less affected side). No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups. Notably, mild, not-distressing and transient dyskinesias occurred in 3 patients after real rTMS in OFF state. Conclusions: The present findings suggest that high-frequency rTMS with H-coil is a safe and potentially effective procedure and prompt larger studies for validation as add-on treatment in PD.
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spelling pubmed-79303212021-03-05 Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study Spagnolo, Francesca Fichera, Mario Chieffo, Raffaella Dalla Costa, Gloria Pisa, Marco Volonté, Maria Antonietta Falautano, Monica Zangen, Abraham Comi, Giancarlo Leocani, Letizia Front Neurol Neurology Background: Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson's Disease (PD) have shown promising results. Objective: To evaluate safety and efficacy of high-frequency rTMS with H-coil in PD in a double-blind, placebo-controlled, randomized study. Methods: Sixty patients with PD were randomized into 3 groups: M1-PFC (real stimulation on primary motor-M1 and pre-frontal cortices-PFC), M1 (real rTMS on M1, sham on PFC), Sham (apparent stimulation). Primary outcome was baseline-normalized percent improvement in UPDRS part III OFF-therapy at the end of treatment (12 rTMS sessions, 4 weeks). Secondary outcomes were improvement in UPDRS part III sub-scores, timed tests, and neuropsychological tests. Statistical analysis compared improvement following real and sham stimulation at the end of the protocol using either a t-test or a Mann-Whitney test. Results: All patients tolerated the treatment and concluded the study. One patient from M1-PFC group was excluded from the analysis due to newly discovered uncontrolled diabetes mellitus. No serious adverse effect was recorded. At the end of treatment, patients receiving real rTMS (M1-PFC and M1 combined) showed significantly greater improvement compared to sham in UPDRS part III total score (p = 0.007), tremor subscore (p = 0.011), and lateralized sub-scores (p = 0.042 for the more affected side; p = 0.012 for the less affected side). No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups. Notably, mild, not-distressing and transient dyskinesias occurred in 3 patients after real rTMS in OFF state. Conclusions: The present findings suggest that high-frequency rTMS with H-coil is a safe and potentially effective procedure and prompt larger studies for validation as add-on treatment in PD. Frontiers Media S.A. 2021-02-18 /pmc/articles/PMC7930321/ /pubmed/33679570 http://dx.doi.org/10.3389/fneur.2020.584713 Text en Copyright © 2021 Spagnolo, Fichera, Chieffo, Dalla Costa, Pisa, Volonté, Falautano, Zangen, Comi and Leocani. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Spagnolo, Francesca
Fichera, Mario
Chieffo, Raffaella
Dalla Costa, Gloria
Pisa, Marco
Volonté, Maria Antonietta
Falautano, Monica
Zangen, Abraham
Comi, Giancarlo
Leocani, Letizia
Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study
title Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study
title_full Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study
title_fullStr Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study
title_full_unstemmed Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study
title_short Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study
title_sort bilateral repetitive transcranial magnetic stimulation with the h-coil in parkinson's disease: a randomized, sham-controlled study
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930321/
https://www.ncbi.nlm.nih.gov/pubmed/33679570
http://dx.doi.org/10.3389/fneur.2020.584713
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