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Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)

BACKGROUND: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arise...

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Autores principales: Mizuno, Katsuhiro, Abe, Takayuki, Ushiba, Junichi, Kawakami, Michiyuki, Ohwa, Tomomi, Hagimura, Kazuto, Ogura, Miho, Okuyama, Kohei, Fujiwara, Toshiyuki, Liu, Meigen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302229/
https://www.ncbi.nlm.nih.gov/pubmed/30522993
http://dx.doi.org/10.2196/12339
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author Mizuno, Katsuhiro
Abe, Takayuki
Ushiba, Junichi
Kawakami, Michiyuki
Ohwa, Tomomi
Hagimura, Kazuto
Ogura, Miho
Okuyama, Kohei
Fujiwara, Toshiyuki
Liu, Meigen
author_facet Mizuno, Katsuhiro
Abe, Takayuki
Ushiba, Junichi
Kawakami, Michiyuki
Ohwa, Tomomi
Hagimura, Kazuto
Ogura, Miho
Okuyama, Kohei
Fujiwara, Toshiyuki
Liu, Meigen
author_sort Mizuno, Katsuhiro
collection PubMed
description BACKGROUND: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. OBJECTIVE: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. METHODS: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. RESULTS: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. CONCLUSIONS: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12339
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spelling pubmed-63022292019-01-16 Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial) Mizuno, Katsuhiro Abe, Takayuki Ushiba, Junichi Kawakami, Michiyuki Ohwa, Tomomi Hagimura, Kazuto Ogura, Miho Okuyama, Kohei Fujiwara, Toshiyuki Liu, Meigen JMIR Res Protoc Protocol BACKGROUND: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. OBJECTIVE: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. METHODS: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. RESULTS: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. CONCLUSIONS: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12339 JMIR Publications 2018-12-06 /pmc/articles/PMC6302229/ /pubmed/30522993 http://dx.doi.org/10.2196/12339 Text en ©Katsuhiro Mizuno, Takayuki Abe, Junichi Ushiba, Michiyuki Kawakami, Tomomi Ohwa, Kazuto Hagimura, Miho Ogura, Kohei Okuyama, Toshiyuki Fujiwara, Meigen Liu. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.12.2018. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Mizuno, Katsuhiro
Abe, Takayuki
Ushiba, Junichi
Kawakami, Michiyuki
Ohwa, Tomomi
Hagimura, Kazuto
Ogura, Miho
Okuyama, Kohei
Fujiwara, Toshiyuki
Liu, Meigen
Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
title Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
title_full Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
title_fullStr Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
title_full_unstemmed Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
title_short Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
title_sort evaluating the effectiveness and safety of the electroencephalogram-based brain-machine interface rehabilitation system for patients with severe hemiparetic stroke: protocol for a randomized controlled trial (best-brain trial)
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302229/
https://www.ncbi.nlm.nih.gov/pubmed/30522993
http://dx.doi.org/10.2196/12339
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