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A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol

Effective, patient-tailored rehabilitation to restore upper-limb motor function in severely impaired stroke patients is still missing. If suitably combined and administered in a personalized fashion, neurotechnologies offer a large potential to assist rehabilitative therapies to enhance individual t...

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Autores principales: Bigoni, Claudia, Zandvliet, Sarah B., Beanato, Elena, Crema, Andrea, Coscia, Martina, Espinosa, Arnau, Henneken, Tina, Hervé, Julie, Oflar, Meltem, Evangelista, Giorgia G., Morishita, Takuya, Wessel, Maximilian J., Bonvin, Christoph, Turlan, Jean-Luc, Birbaumer, Niels, Hummel, Friedhelm C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9301337/
https://www.ncbi.nlm.nih.gov/pubmed/35873764
http://dx.doi.org/10.3389/fneur.2022.919511
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author Bigoni, Claudia
Zandvliet, Sarah B.
Beanato, Elena
Crema, Andrea
Coscia, Martina
Espinosa, Arnau
Henneken, Tina
Hervé, Julie
Oflar, Meltem
Evangelista, Giorgia G.
Morishita, Takuya
Wessel, Maximilian J.
Bonvin, Christoph
Turlan, Jean-Luc
Birbaumer, Niels
Hummel, Friedhelm C.
author_facet Bigoni, Claudia
Zandvliet, Sarah B.
Beanato, Elena
Crema, Andrea
Coscia, Martina
Espinosa, Arnau
Henneken, Tina
Hervé, Julie
Oflar, Meltem
Evangelista, Giorgia G.
Morishita, Takuya
Wessel, Maximilian J.
Bonvin, Christoph
Turlan, Jean-Luc
Birbaumer, Niels
Hummel, Friedhelm C.
author_sort Bigoni, Claudia
collection PubMed
description Effective, patient-tailored rehabilitation to restore upper-limb motor function in severely impaired stroke patients is still missing. If suitably combined and administered in a personalized fashion, neurotechnologies offer a large potential to assist rehabilitative therapies to enhance individual treatment effects. AVANCER (clinicaltrials.gov NCT04448483) is a two-center proof-of-concept trial with an individual based cumulative longitudinal intervention design aiming at reducing upper-limb motor impairment in severely affected stroke patients with the help of multiple neurotechnologies. AVANCER will determine feasibility, safety, and effectivity of this innovative intervention. Thirty chronic stroke patients with a Fugl-Meyer assessment of the upper limb (FM-UE) <20 will be recruited at two centers. All patients will undergo the cumulative personalized intervention within two phases: the first uses an EEG-based brain-computer interface to trigger a variety of patient-tailored movements supported by multi-channel functional electrical stimulation in combination with a hand exoskeleton. This phase will be continued until patients do not improve anymore according to a quantitative threshold based on the FM-UE. The second interventional phase will add non-invasive brain stimulation by means of anodal transcranial direct current stimulation to the motor cortex to the initial approach. Each phase will last for a minimum of 11 sessions. Clinical and multimodal assessments are longitudinally acquired, before the first interventional phase, at the switch to the second interventional phase and at the end of the second interventional phase. The primary outcome measure is the 66-point FM-UE, a significant improvement of at least four points is hypothesized and considered clinically relevant. Several clinical and system neuroscience secondary outcome measures are additionally evaluated. AVANCER aims to provide evidence for a safe, effective, personalized, adjuvant treatment for patients with severe upper-extremity impairment for whom to date there is no efficient treatment available.
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spelling pubmed-93013372022-07-22 A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol Bigoni, Claudia Zandvliet, Sarah B. Beanato, Elena Crema, Andrea Coscia, Martina Espinosa, Arnau Henneken, Tina Hervé, Julie Oflar, Meltem Evangelista, Giorgia G. Morishita, Takuya Wessel, Maximilian J. Bonvin, Christoph Turlan, Jean-Luc Birbaumer, Niels Hummel, Friedhelm C. Front Neurol Neurology Effective, patient-tailored rehabilitation to restore upper-limb motor function in severely impaired stroke patients is still missing. If suitably combined and administered in a personalized fashion, neurotechnologies offer a large potential to assist rehabilitative therapies to enhance individual treatment effects. AVANCER (clinicaltrials.gov NCT04448483) is a two-center proof-of-concept trial with an individual based cumulative longitudinal intervention design aiming at reducing upper-limb motor impairment in severely affected stroke patients with the help of multiple neurotechnologies. AVANCER will determine feasibility, safety, and effectivity of this innovative intervention. Thirty chronic stroke patients with a Fugl-Meyer assessment of the upper limb (FM-UE) <20 will be recruited at two centers. All patients will undergo the cumulative personalized intervention within two phases: the first uses an EEG-based brain-computer interface to trigger a variety of patient-tailored movements supported by multi-channel functional electrical stimulation in combination with a hand exoskeleton. This phase will be continued until patients do not improve anymore according to a quantitative threshold based on the FM-UE. The second interventional phase will add non-invasive brain stimulation by means of anodal transcranial direct current stimulation to the motor cortex to the initial approach. Each phase will last for a minimum of 11 sessions. Clinical and multimodal assessments are longitudinally acquired, before the first interventional phase, at the switch to the second interventional phase and at the end of the second interventional phase. The primary outcome measure is the 66-point FM-UE, a significant improvement of at least four points is hypothesized and considered clinically relevant. Several clinical and system neuroscience secondary outcome measures are additionally evaluated. AVANCER aims to provide evidence for a safe, effective, personalized, adjuvant treatment for patients with severe upper-extremity impairment for whom to date there is no efficient treatment available. Frontiers Media S.A. 2022-07-07 /pmc/articles/PMC9301337/ /pubmed/35873764 http://dx.doi.org/10.3389/fneur.2022.919511 Text en Copyright © 2022 Bigoni, Zandvliet, Beanato, Crema, Coscia, Espinosa, Henneken, Hervé, Oflar, Evangelista, Morishita, Wessel, Bonvin, Turlan, Birbaumer and Hummel. https://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
Bigoni, Claudia
Zandvliet, Sarah B.
Beanato, Elena
Crema, Andrea
Coscia, Martina
Espinosa, Arnau
Henneken, Tina
Hervé, Julie
Oflar, Meltem
Evangelista, Giorgia G.
Morishita, Takuya
Wessel, Maximilian J.
Bonvin, Christoph
Turlan, Jean-Luc
Birbaumer, Niels
Hummel, Friedhelm C.
A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol
title A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol
title_full A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol
title_fullStr A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol
title_full_unstemmed A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol
title_short A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol
title_sort novel patient-tailored, cumulative neurotechnology-based therapy for upper-limb rehabilitation in severely impaired chronic stroke patients: the avancer study protocol
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9301337/
https://www.ncbi.nlm.nih.gov/pubmed/35873764
http://dx.doi.org/10.3389/fneur.2022.919511
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