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Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial
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Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial
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Journal Article
Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial
2021
Overview
In this forthcoming multicenter, prospective, randomized, double-blind placebo-controlled trial, we will investigate the augmentative effects of a selective serotonin reuptake inhibitor, escitalopram, on language therapy in individuals with post-stroke aphasia. We hypothesize that, when combined with language therapy, daily escitalopram will result in greater improvement than placebo in an untrained picture naming task (Philadelphia Naming Test short form) administered one week after the end of language therapy. We also will examine whether escitalopram’s effect on language is independent of its effect on depression, varies with lesion location, or is associated with increased functional connectivity within the left hemisphere. Finally, we will examine whether individuals with BDNF met alleles show reduced response to treatment and reduced changes in connectivity. We expect to enroll 88 participants over four years. Participants are given escitalopram or placebo within one week of their stroke for 90 days and receive fifteen 45-minute computer-delivered sessions of language treatment beginning 60 days from the start of drug therapy. Patients then complete a comprehensive assessment of language at one, five, and twenty weeks after the last language therapy session. ELISA is the first randomized, controlled trial evaluating the effect of a selective serotonin reuptake inhibitor on the improvement of language in people with aphasia undergoing language treatment during the acute to subacute post-stroke period. Trial registration : The trial is registered with ClinicalTrials.gov NCT03843463 .
Publisher
Public Library of Science,Public Library of Science (PLoS)
Subject
/ Aphasia
/ Brain-derived neurotrophic factor
/ Escitalopram - therapeutic use
/ Humans
/ Language
/ Medicine and Health Sciences
/ Multicenter Studies as Topic
/ Naming
/ Placebos
/ Randomized Controlled Trials as Topic
/ Research and Analysis Methods
/ Selective Serotonin Reuptake Inhibitors - therapeutic use
/ Stroke
