In this project, the investigators will investigate the effects of a selective serotonin reuptake inhibitor (SSRI), escitalopram, on augmenting language therapy effectiveness, as measured by naming untrained pictures and describing pictures, in individuals with aphasia in the acute and subacute post stroke period (i.e., within three months post stroke).
In this project, the investigators will investigate the effects of a selective serotonin reuptake inhibitor (SSRI), escitalopram, on augmenting language therapy effectiveness, as measured by naming untrained pictures and describing pictures, in individuals with aphasia in the acute and subacute post stroke period (i.e., within three months post stroke). There has been no previous randomized controlled trial (RCT) to evaluate the effect of daily SSRI in the first three months after stroke on improvement of language in people undergoing aphasia treatment. It is plausible that SSRIs, which elevate synaptic serotonin, might enhance recovery by augmenting synaptic plasticity. The investigators propose to conduct a Phase 2 multi-center, randomized, double blind, placebo-controlled trial of escitalopram for augmenting language intervention in subacute stroke. The investigators hypothesize that daily escitalopram for 90 days after stroke results in greater improvement (compared to placebo) in naming untrained pictures, as well as greater increase in content of picture description and greater improvement in morphosyntactic production, when combined with speech and language treatment (SALT). A second aim is to evaluate the mechanisms of language recovery in individuals who receive active medical treatment and those who receive placebo, using resting state functional magnetic resonance imaging (rsfMRI) and genetic testing. The investigators hypothesize that greater improvement in language is associated with increased connectivity within the left hemisphere language network on rsfMRI in participants who receive escitalopram than in those who receive placebo, independently of improvement in depression. The investigators also hypothesize that the effects are greatest in individuals with val/val allele of brain-derived neurotrophic factor (BDNF) - (consistent with previous studies showing a greater response to treatment and greater neuroplasticity in people with the val/val allele than those with one or more met alleles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
Escitalopram tablet
Sugar pill manufactured to mimic escitalopram 10 mg tablet
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGUniversity of South Carolina
Columbia, South Carolina, United States
RECRUITINGChange in Philadelphia Naming Test short-form accuracy score
Number of correctly named items of 30 total items on the computerized picture naming assessment. Scores ranges from 0 to 30 with higher scores meaning better naming ability.
Time frame: Baseline, 1 week after computer-delivered naming treatment
Language production as assessed by lexical features of discourse in "Cookie Theft" picture description
Lexical features, meaning carrying units of language (morphemes), will be counted for each Cookie Theft picture description. There is no maximum number of meaning carrying units, but norms are available to assist in the interpretation of this performance.
Time frame: Baseline, 5 weeks after computer-delivered naming treatment
Language production as assessed by content units included in picture description of "Cookie Theft"
Content units are based on a standard scoring template of commonly identified concepts (nouns and verbs) in the left and right regions of the "Cookie Theft" picture. Participants either include or fail to include 30 concepts on the left side of the picture and 23 concepts on the right side of the picture. A ratio of included left content units to included right content units then can be calculated and interpreted as a measure of hemispatial attention.
Time frame: Baseline, 5 weeks after computer-delivered naming treatment
Language production as assessed by rate of syllables per content unit produced in "Cookie Theft" picture description
Syllables included in the picture description are counted. Content units are based on a standard scoring template of commonly identified concepts (nouns and verbs) in the left and right regions of the "Cookie Theft" picture. Participants either include or fail to include 30 concepts on the left side of the picture and 23 concepts on the right side of the picture. The average rate of syllables per content unit produced can then be calculated and interpreted as a measure of efficiency in producing relevant information in the task.
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Time frame: Baseline, 5 weeks after computer-delivered naming treatment
Depression as assessed by Patient Health Questionnaire (PHQ-9)
9 item scale scored 0-3 for each item. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression. PHQ-9 \>15 or suicidal ideation suggest depression sufficient for exclusion or removal from study.
Time frame: Baseline, 1 week after computer-delivered naming treatment
Language production as assessed by Morphosyntactic Generation (MorGen) Test
60 item assessment of word morphology (e.g., plurals, possessives) and modifiers (e.g., number, size, color). Each item is scored based on produced accurate descriptors of an image relative to a second reference image (e.g., patients see two trees, one larger than the other, and the phrase "little tree" is elicited). Patients are scored for objects correctly named (nouns) out of 60, instances of correct use of plural marker out of 31, instances of correct use of numbers out of 8, instances of correct modifiers denoting size out of 16, instances of correct modifiers denoting color out of 19, instances of correct modifiers denoting possessive markers out of 17, and instances of correctly named possessing individuals (proper names provided on screen) out of 17. These scores can then be interpreted separately or averaged to interpret a broad morphosyntactic accuracy score.
Time frame: Baseline, 1 week after computer-delivered naming treatment
Stroke severity as assessed by NIH Stroke Scale (NIHSS)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
Time frame: Baseline, 5 weeks after computer-delivered naming treatment, 20 weeks after computer-delivered naming treatment
Post-stroke level of disability as assessed by modified Rankin Scale (mRS)
The mRS is a 6-level scale from "0-No symptoms" to "6-dead" used to evaluate the degree of disability in patients who have suffered a stroke.
Time frame: Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand strength
Right hand strength assessment by dynamometer
Time frame: Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand dexterity
Right hand dexterity assessment by 9 peg board test
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Change in new vocabulary items will be counted for each noun, verb, and adjective in the Cinderella retelling. There is no maximum measure of lexical diversity, but norms are available to assist in the interpretation of this performance.
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in incidence of new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Change in incidence of each new item will be counted for each noun, verb, and adjective in the Cinderella retelling. There is no maximum measure of lexical diversity, but norms are available to assist in the interpretation of this performance.
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in language production as assessed by speech errors produced during the story retelling of "Cinderella"
Change in number of errors will be counted after each retelling is recorded
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella"
Change in pauses will be counted after each retelling is recorded
Time frame: Baseline, 1 week after computer-delivered naming treatment