Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial

Detalhes bibliográficos
Autor(a) principal: Luvizutto, Gustavo Jose [UNESP]
Data de Publicação: 2016
Outros Autores: Soares Rizzati, Gabriela Rizzo, Fogaroli, Marcelo Ortolani, Rodrigues, Rodrigo Thomazi, Ribeiro, Priscila Watson, Carvalho Nunes, Helio Rubens de, Braga, Gabriel Pereira, Molle da Costa, Rafael Dalle, Zanati Bazan, Silmeia Garcia, Lima Resende, Luiz Antonio de, Conforto, Adriana Bastos, Bazan, Rodrigo
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1186/s13063-016-1598-4
http://hdl.handle.net/11449/164744
Resumo: Background: Unilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects that are presented in the spatial hemisphere that is contralateral to the lesioned hemisphere of the brain. USN has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), has been used in people who have been affected by USN after stroke. The effects of such treatment could provide new insights for health professionals and policy-makers. The aim of this study will be to evaluate the effectiveness and safety of tDCS for USN after stroke. Methods: A prospective randomized controlled trial with two parallel groups will be conducted, which will aim to recruit 60 patients with USN after ischemic or hemorrhagic stroke. Participants will be randomly placed into the following four treatment groups: (1) anodal tDCS over the right parietal lobe (n = 15), (2) cathodal tDCS over the left parietal lobe (n = 15), (3) a sham group of anodal tDCS over the right parietal lobe (n = 15), and (4) a sham group of cathodal tDCS over the left parietal lobe (n = 15). Blinded assessors will conduct two baseline assessments and one post-intervention assessment. The primary outcome measure will be the level of USN as assessed by the conventional Behavioral Inattention Tasks and the Catherine Bergego Scale. Secondary measures will include neurological capacity (based on the Scandinavian Stroke Scale), functional capacity (based on the Functional Independence Measure and Modified Rankin Scale), autonomy (based on the Barthel Index), and quality of life (based on the EuroQol-5D). Group allocation will be concealed, and all analyses will be based on an intention-to-treat principle. Discussion: This study will explore the effects of more than 15 sessions of tDCS on the level of USN, functional capacity, autonomy, and quality of life in patients with USN after stroke. This proposed study has the potential to identify a new, evidence-based intervention that can enhance perception and independent living in patients with USN after stroke.
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spelling Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trialStrokeUnilateral spatial neglectTranscranial direct current stimulationBackground: Unilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects that are presented in the spatial hemisphere that is contralateral to the lesioned hemisphere of the brain. USN has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), has been used in people who have been affected by USN after stroke. The effects of such treatment could provide new insights for health professionals and policy-makers. The aim of this study will be to evaluate the effectiveness and safety of tDCS for USN after stroke. Methods: A prospective randomized controlled trial with two parallel groups will be conducted, which will aim to recruit 60 patients with USN after ischemic or hemorrhagic stroke. Participants will be randomly placed into the following four treatment groups: (1) anodal tDCS over the right parietal lobe (n = 15), (2) cathodal tDCS over the left parietal lobe (n = 15), (3) a sham group of anodal tDCS over the right parietal lobe (n = 15), and (4) a sham group of cathodal tDCS over the left parietal lobe (n = 15). Blinded assessors will conduct two baseline assessments and one post-intervention assessment. The primary outcome measure will be the level of USN as assessed by the conventional Behavioral Inattention Tasks and the Catherine Bergego Scale. Secondary measures will include neurological capacity (based on the Scandinavian Stroke Scale), functional capacity (based on the Functional Independence Measure and Modified Rankin Scale), autonomy (based on the Barthel Index), and quality of life (based on the EuroQol-5D). Group allocation will be concealed, and all analyses will be based on an intention-to-treat principle. Discussion: This study will explore the effects of more than 15 sessions of tDCS on the level of USN, functional capacity, autonomy, and quality of life in patients with USN after stroke. This proposed study has the potential to identify a new, evidence-based intervention that can enhance perception and independent living in patients with USN after stroke.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Botucatu Med Sch, Rehabil Dept, Prof Montenegro Ave, Botucatu, SP, BrazilBotucatu Med Sch, Prof Montenegro Ave, Botucatu, SP, BrazilBotucatu Med Sch, Dept Neurol Psychol & Psychiat, Prof Montenegro Ave, Botucatu, SP, BrazilBotucatu Med Sch, Dept Internal Med, Prof Montenegro Ave, Botucatu, SP, BrazilUniv Sao Paulo, Neurol Clin Div, Sao Paulo, BrazilUniv Estadual Paulista, Botucatu Sch Med, BR-18618970 Botucatu, SP, BrazilUniv Estadual Paulista, Botucatu Sch Med, BR-18618970 Botucatu, SP, BrazilBiomed Central LtdBotucatu Med SchUniversidade de São Paulo (USP)Universidade Estadual Paulista (Unesp)Luvizutto, Gustavo Jose [UNESP]Soares Rizzati, Gabriela RizzoFogaroli, Marcelo OrtolaniRodrigues, Rodrigo ThomaziRibeiro, Priscila WatsonCarvalho Nunes, Helio Rubens deBraga, Gabriel PereiraMolle da Costa, Rafael DalleZanati Bazan, Silmeia GarciaLima Resende, Luiz Antonio deConforto, Adriana BastosBazan, Rodrigo2018-11-26T17:55:56Z2018-11-26T17:55:56Z2016-10-03info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article9application/pdfhttp://dx.doi.org/10.1186/s13063-016-1598-4Trials. London: Biomed Central Ltd, v. 17, 9 p., 2016.1745-6215http://hdl.handle.net/11449/16474410.1186/s13063-016-1598-4WOS:000384848100001WOS000384848100001.pdfWeb of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengTrials1,291info:eu-repo/semantics/openAccess2023-11-07T06:08:02Zoai:repositorio.unesp.br:11449/164744Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462023-11-07T06:08:02Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
title Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
spellingShingle Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
Luvizutto, Gustavo Jose [UNESP]
Stroke
Unilateral spatial neglect
Transcranial direct current stimulation
title_short Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
title_full Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
title_fullStr Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
title_full_unstemmed Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
title_sort Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
author Luvizutto, Gustavo Jose [UNESP]
author_facet Luvizutto, Gustavo Jose [UNESP]
Soares Rizzati, Gabriela Rizzo
Fogaroli, Marcelo Ortolani
Rodrigues, Rodrigo Thomazi
Ribeiro, Priscila Watson
Carvalho Nunes, Helio Rubens de
Braga, Gabriel Pereira
Molle da Costa, Rafael Dalle
Zanati Bazan, Silmeia Garcia
Lima Resende, Luiz Antonio de
Conforto, Adriana Bastos
Bazan, Rodrigo
author_role author
author2 Soares Rizzati, Gabriela Rizzo
Fogaroli, Marcelo Ortolani
Rodrigues, Rodrigo Thomazi
Ribeiro, Priscila Watson
Carvalho Nunes, Helio Rubens de
Braga, Gabriel Pereira
Molle da Costa, Rafael Dalle
Zanati Bazan, Silmeia Garcia
Lima Resende, Luiz Antonio de
Conforto, Adriana Bastos
Bazan, Rodrigo
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Botucatu Med Sch
Universidade de São Paulo (USP)
Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Luvizutto, Gustavo Jose [UNESP]
Soares Rizzati, Gabriela Rizzo
Fogaroli, Marcelo Ortolani
Rodrigues, Rodrigo Thomazi
Ribeiro, Priscila Watson
Carvalho Nunes, Helio Rubens de
Braga, Gabriel Pereira
Molle da Costa, Rafael Dalle
Zanati Bazan, Silmeia Garcia
Lima Resende, Luiz Antonio de
Conforto, Adriana Bastos
Bazan, Rodrigo
dc.subject.por.fl_str_mv Stroke
Unilateral spatial neglect
Transcranial direct current stimulation
topic Stroke
Unilateral spatial neglect
Transcranial direct current stimulation
description Background: Unilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects that are presented in the spatial hemisphere that is contralateral to the lesioned hemisphere of the brain. USN has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), has been used in people who have been affected by USN after stroke. The effects of such treatment could provide new insights for health professionals and policy-makers. The aim of this study will be to evaluate the effectiveness and safety of tDCS for USN after stroke. Methods: A prospective randomized controlled trial with two parallel groups will be conducted, which will aim to recruit 60 patients with USN after ischemic or hemorrhagic stroke. Participants will be randomly placed into the following four treatment groups: (1) anodal tDCS over the right parietal lobe (n = 15), (2) cathodal tDCS over the left parietal lobe (n = 15), (3) a sham group of anodal tDCS over the right parietal lobe (n = 15), and (4) a sham group of cathodal tDCS over the left parietal lobe (n = 15). Blinded assessors will conduct two baseline assessments and one post-intervention assessment. The primary outcome measure will be the level of USN as assessed by the conventional Behavioral Inattention Tasks and the Catherine Bergego Scale. Secondary measures will include neurological capacity (based on the Scandinavian Stroke Scale), functional capacity (based on the Functional Independence Measure and Modified Rankin Scale), autonomy (based on the Barthel Index), and quality of life (based on the EuroQol-5D). Group allocation will be concealed, and all analyses will be based on an intention-to-treat principle. Discussion: This study will explore the effects of more than 15 sessions of tDCS on the level of USN, functional capacity, autonomy, and quality of life in patients with USN after stroke. This proposed study has the potential to identify a new, evidence-based intervention that can enhance perception and independent living in patients with USN after stroke.
publishDate 2016
dc.date.none.fl_str_mv 2016-10-03
2018-11-26T17:55:56Z
2018-11-26T17:55:56Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1186/s13063-016-1598-4
Trials. London: Biomed Central Ltd, v. 17, 9 p., 2016.
1745-6215
http://hdl.handle.net/11449/164744
10.1186/s13063-016-1598-4
WOS:000384848100001
WOS000384848100001.pdf
url http://dx.doi.org/10.1186/s13063-016-1598-4
http://hdl.handle.net/11449/164744
identifier_str_mv Trials. London: Biomed Central Ltd, v. 17, 9 p., 2016.
1745-6215
10.1186/s13063-016-1598-4
WOS:000384848100001
WOS000384848100001.pdf
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Trials
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dc.format.none.fl_str_mv 9
application/pdf
dc.publisher.none.fl_str_mv Biomed Central Ltd
publisher.none.fl_str_mv Biomed Central Ltd
dc.source.none.fl_str_mv Web of Science
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
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