Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial.

adult neurology anomia therapy bilingual aphasia clinical trials computational modeling internal medicine neurology randomized controlled trial rehabilitation rehabilitation medicine semantic treatment stroke therapeutics

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
18 11 2020
Historique:
entrez: 19 11 2020
pubmed: 20 11 2020
medline: 15 5 2021
Statut: epublish

Résumé

Bilinguals with aphasia (BWA) present varying degrees of lexical access impairment and recovery across their two languages. Because both languages may benefit from therapy, identifying the optimal target language for treatment is a current challenge for research and clinical practice. Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia. Here, we aim to determine whether BiLex can predict treatment outcomes in BWA in the treated and the untreated language and compare these outcome predictions to determine the optimal language for rehabilitation. The study involves a prospective parallel-group, double-blind, randomised controlled trial. Forty-eight Spanish-English BWA will receive 20 sessions of semantic treatment for lexical retrieval deficits in one of their languages and will complete assessments in both languages prior and after treatment. Participants will be randomly assigned to an experimental group receiving treatment in the optimal language determined by the model or a control group receiving treatment in the language opposite to the model's recommendation. Primary treatment outcomes include naming probes while secondary treatment outcomes include tests tapping additional language domains. Treatment outcomes will be compared across the two groups using 2×2 mixed effect models for repeated measures Analysis of variance (ANOVA) on metrics of treatment effects commonly employed in rehabilitation studies (ie, effect size and percentage change). All procedures included in this protocol (protocol number 29, issue date: 19 March 2019) were approved by the Boston University Charles River Campus Institutional Review Board at Boston, Massachusetts (reference number: 4492E). The results of this study will be published in peer-reviewed scientific journals and will be presented at national and international conferences. NCT02916524.

Identifiants

pubmed: 33208330
pii: bmjopen-2020-040495
doi: 10.1136/bmjopen-2020-040495
pmc: PMC7677370
doi:

Banques de données

ClinicalTrials.gov
['NCT02916524']

Types de publication

Clinical Trial Protocol Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e040495

Subventions

Organisme : NIDCD NIH HHS
ID : U01 DC014922
Pays : United States

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: SK serves as a consultant for The Learning Corporation with no scientific overlap with the present study. Claudia Peñaloza, Michael Scimeca and Erin Carpenter are currently employed by Boston University under NIH/NIDCD grant number U01DC014922 awarded to SK.

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Auteurs

Claudia Peñaloza (C)

Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA penaloza@bu.edu.

Maria Dekhtyar (M)

Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.

Michael Scimeca (M)

Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.

Erin Carpenter (E)

Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.

Nishaat Mukadam (N)

Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.

Swathi Kiran (S)

Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.

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Classifications MeSH