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Trial record 16 of 468 for:    ESCITALOPRAM AND Cholinergic

Escitalopram and Language Intervention for Subacute Aphasia (ELISA)

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ClinicalTrials.gov Identifier: NCT03843463
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
University of South Carolina
Medical University of South Carolina
University of California, Irvine
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 18, 2019
Last Update Posted Date March 6, 2019
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
Change in Philadelphia Naming Test accuracy score [ Time Frame: Baseline, 1 week after computer-delivered naming treatment ]
Number of correctly named items of 175 total items on the computerized picture naming assessment. Scores ranges from 0 to 175 with higher scores meaning better naming ability.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03843463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Language production as assessed by lexical features of discourse in "Cookie Theft" picture description [ Time Frame: 2 months after enrollment ]
    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.
  • Language production as assessed by content units included in picture description of "Cookie Theft" [ Time Frame: 2 months after enrollment ]
    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.
  • Language production as assessed by rate of syllables per content unit produced in "Cookie Theft" picture description [ Time Frame: 2 months after enrollment ]
    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.
  • Depression as assessed by Patient Health Questionnaire (PHQ-9) [ Time Frame: 2 months after enrollment ]
    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.
  • Language production as assessed by Morphosyntactic Generation (MorGen) Test [ Time Frame: 2 months after enrollment ]
    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.
  • Stroke severity as assessed by NIH Stroke Scale (NIHSS) [ Time Frame: 2 months after enrollment ]
    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.
  • Post-stroke quality of life as assessed by Stroke Impact Scale (SIS) [ Time Frame: 2 months after enrollment ]
    59 item scale scored 1-5 for each item assessing a variety of domains: strength, hand function, activities of daily living, mobility, communication, emotion, memory/thinking, and participation. Scores for each domain can range from 0-100, with 100 indicating the most severe disturbance to the patient's quality of life.
  • Post-stroke level of disability as assessed by modified Rankin Scale (mRS) [ Time Frame: 2 months after enrollment ]
    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.
  • Stroke paresis severity as assessed by right arm strength [ Time Frame: 2 months after enrollment ]
    Right arm strength assessment by the neurologist (measured via clinical opinion) is a common measure of upper motor paresis associated with left hemisphere ischemic stroke. Strength in the arm is graded from 0 to 5 with 5 being full strength.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram and Language Intervention for Subacute Aphasia
Official Title  ICMJE Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Aphasia
  • Stroke
Intervention  ICMJE
  • Drug: Escitalopram 10mg
    Escitalopram tablet
    Other Name: Lexapro
  • Drug: Placebo
    Sugar pill manufactured to mimic escitalopram 10 mg tablet
    Other Name: Placebo (for Escitalopram)
  • Behavioral: Computer-delivered naming treatment
    15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
    Other Name: CoDeNT
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Escitalopram 10mg
    • Behavioral: Computer-delivered naming treatment
  • Placebo Comparator: Naming Treatment + Placebo
    10 mg placebo daily for three months
    Interventions:
    • Drug: Placebo
    • Behavioral: Computer-delivered naming treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 another to provide informed consent.
  • Participants must be age 18 or older but not older than 99 years.
  • Participants must be within 5 days of onset of stroke.
  • Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.

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
  • Current severe depression, defined as a score of > 15 on the Patient Health Questionnaire
  • 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 contraindications to escitalopram that may be identified
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Argye Hillis-Trupe, MD (410) 614-2381 argye@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843463
Other Study ID Numbers  ICMJE IRB00203667
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • University of South Carolina
  • Medical University of South Carolina
  • University of California, Irvine
Investigators  ICMJE
Principal Investigator: Argye Hillis-Trupe, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP