Escitalopram and Language Intervention for Subacute Aphasia (ELISA)

November 30, 2023 updated by: Johns Hopkins University

Escitalopram and Language Intervention for Subacute Aphasia (ELISA)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Argye Hillis-Trupe, MD
  • Phone Number: (410) 614-2381
  • Email: argye@jhmi.edu

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins School of Medicine
        • Contact:
          • Argye E Hillis, MD
          • Phone Number: 410-812-6716
        • Contact:
          • Catherine Kelly, MA
          • Phone Number: 410-502-6045
          • Email: chead2@jhu.edu
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
      • Columbia, South Carolina, United States, 29208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have sustained an acute ischemic left hemisphere stroke.
  • Participants must be fluent speakers of English by self-report.
  • Participants must be capable of giving informed consent or indicating a legally authorized representative to provide informed consent.
  • Participants must be age 18 or older.
  • Participants must be within 5 days of onset of stroke.
  • Participants must be pre-morbidly right-handed by self-report.
  • Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised (Aphasia Quotient < 93.8).

Exclusion Criteria:

  • Previous neurological disease affecting the brain including previous symptomatic stroke
  • Diagnosis of schizophrenia, autism, or other psychiatric or neurological condition that affects naming/language
  • A history of additional risk factors for torsades de pointes (TdP; e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Current severe depression, defined as a score of > 15 on the Patient Health Questionnaire (PHQ-9)
  • Uncorrected visual loss or hearing loss by self-report
  • Use of any medication approved by the FDA for treatment of depression at the time of stroke onset
  • Concomitant use of any monoamine oxidase inhibitors (MAOIs) or pimozide, or other drugs that prolong the QT/QTc interval, triptans (and other 5-Hydroxytryptamine Receptor Agonists), or other contraindications to escitalopram that may be identified.
  • A QTc greater than 450 milliseconds on electrocardiogram or evidence of hyponatremia (Na < 130) at baseline
  • Pregnancy at the time of stroke or planning to become pregnant during the study term.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naming Treatment + Escitalopram
10 mg escitalopram daily for three months (escalating from 5 mg per day for the first week and tapering to 5 mg per day for the last two weeks)
Drug: Escitalopram 10mg
Escitalopram tablet
Other Names:
  • Lexapro
Behavioral: Computer-delivered naming treatment
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Other Names:
  • Computer-delivered naming treatment (CoDeNT)
Placebo Comparator: Naming Treatment + Placebo
10 mg placebo daily for three months
Behavioral: Computer-delivered naming treatment
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Other Names:
  • Computer-delivered naming treatment (CoDeNT)
Drug: Placebo
Sugar pill manufactured to mimic escitalopram 10 mg tablet
Other Names:
  • Placebo (for Escitalopram)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Philadelphia Naming Test short-form accuracy score
Time Frame: Baseline, 1 week after computer-delivered naming treatment
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.
Baseline, 1 week after computer-delivered naming treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Language production as assessed by lexical features of discourse in "Cookie Theft" picture description
Time Frame: Baseline, 5 weeks after computer-delivered naming treatment
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.
Baseline, 5 weeks after computer-delivered naming treatment
Language production as assessed by content units included in picture description of "Cookie Theft"
Time Frame: Baseline, 5 weeks after computer-delivered naming treatment
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.
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
Time Frame: Baseline, 5 weeks after computer-delivered naming treatment
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.
Baseline, 5 weeks after computer-delivered naming treatment
Depression as assessed by Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 1 week after computer-delivered naming treatment
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.
Baseline, 1 week after computer-delivered naming treatment
Language production as assessed by Morphosyntactic Generation (MorGen) Test
Time Frame: Baseline, 1 week after computer-delivered naming treatment
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.
Baseline, 1 week after computer-delivered naming treatment
Stroke severity as assessed by NIH Stroke Scale (NIHSS)
Time Frame: Baseline, 5 weeks after computer-delivered naming treatment, 20 weeks after computer-delivered naming treatment
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.
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)
Time Frame: Baseline, 1 week after computer-delivered naming treatment
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.
Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand strength
Time Frame: Baseline, 1 week after computer-delivered naming treatment
Right hand strength assessment by dynamometer
Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand dexterity
Time Frame: Baseline, 1 week after computer-delivered naming treatment
Right hand dexterity assessment by 9 peg board test
Baseline, 1 week after computer-delivered naming treatment
Change in new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Time Frame: Baseline, 1 week after computer-delivered naming treatment
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.
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"
Time Frame: Baseline, 1 week after computer-delivered naming treatment
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.
Baseline, 1 week after computer-delivered naming treatment
Change in language production as assessed by speech errors produced during the story retelling of "Cinderella"
Time Frame: Baseline, 1 week after computer-delivered naming treatment
Change in number of errors will be counted after each retelling is recorded
Baseline, 1 week after computer-delivered naming treatment
Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella"
Time Frame: Baseline, 1 week after computer-delivered naming treatment
Change in pauses will be counted after each retelling is recorded
Baseline, 1 week after computer-delivered naming treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Medical University of South Carolina
University of South Carolina
University of California, Irvine
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Argye Hillis-Trupe, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2021

Primary Completion (Estimated)

September 18, 2025

Study Completion (Estimated)

January 18, 2026

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00268564
  • P50DC014664 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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