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Escitalopram + Language Therapy for Aphasia (ELISA Trial)

Phase 2

Recruiting

Led By Argye Hillis-Trupe, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week after computer-delivered naming treatment

Awards & highlights

ELISA Trial Summary

This trial will investigate whether the drug escitalopram can help improve language skills in people with aphasia who are receiving therapy, compared to those who are receiving therapy without the drug.

Who is the study for?

This trial is for right-handed, English-speaking adults who've had a left hemisphere ischemic stroke within the past 5 days and have been diagnosed with aphasia. They must be able to consent or have someone to do it for them. Excluded are those with prior brain diseases, severe visual/hearing loss, depression medication use at stroke onset, pregnancy, certain heart risks or psychiatric conditions affecting language.Check my eligibility

What is being tested?

The study tests if Escitalopram (an SSRI) can improve the effectiveness of computer-delivered naming therapy for people with aphasia after a recent stroke. Participants will either receive Escitalopram or a placebo alongside their language therapy sessions.See study design

What are the potential side effects?

Escitalopram may cause side effects like nausea, sleep disturbances, fatigue, dry mouth and increased sweating. It might also affect heart rhythm (QTc prolongation), which is why individuals with certain heart conditions are excluded from the trial.

ELISA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can make my own medical decisions or have someone who can.

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I am 18 years old or older.

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I had a stroke less than 5 days ago.

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I had a stroke affecting the left side of my brain.

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I have been diagnosed with aphasia.

ELISA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week after computer-delivered naming treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week after computer-delivered naming treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week after computer-delivered naming treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Philadelphia Naming Test short-form accuracy score

Secondary outcome measures

Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella"

Change in incidence of new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"

Change in language production as assessed by speech errors produced during the story retelling of "Cinderella"

+10 more

ELISA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Naming Treatment + EscitalopramExperimental Treatment2 Interventions

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)

Group II: Naming Treatment + PlaceboPlacebo Group2 Interventions

10 mg placebo daily for three months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Escitalopram 10mg

2022

Completed Phase 4

~160

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,077 Total Patients Enrolled

13 Trials studying Aphasia

1,001 Patients Enrolled for Aphasia

University of California, IrvineOTHER

544 Previous Clinical Trials

1,922,955 Total Patients Enrolled

Medical University of South CarolinaOTHER

933 Previous Clinical Trials

7,394,547 Total Patients Enrolled

5 Trials studying Aphasia

339 Patients Enrolled for Aphasia

Media Library

Computer-delivered naming treatment Clinical Trial Eligibility Overview. Trial Name: NCT03843463 — Phase 2

Aphasia Research Study Groups: Naming Treatment + Escitalopram, Naming Treatment + Placebo

Aphasia Clinical Trial 2023: Computer-delivered naming treatment Highlights & Side Effects. Trial Name: NCT03843463 — Phase 2

Computer-delivered naming treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843463 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being welcomed into this experiment?

"Yes, as of 4/28/2022 this clinical trial is still seeking participants. The study was initially posted on 7/18/2021 according to the website clinicaltrials.gov"

Answered by AI

Does this research include any individuals below the age of 55?

"The age limit to participate in this clinical trial is 18 years old. The maximum age is 99 years old."

Answered by AI

What goals does this research aim to achieve?

"The aim of this study is to monitor the change in accuracy scores for the Philadelphia Naming Test short-form over a period of one week. Additionally, secondary outcomes such as post-stroke quality of life (as assessed by the Stroke Impact Scale), stroke paresis severity (as assessed by right arm strength), and stroke severity (as assessed by the NIH Stroke Scale) will be monitored."

Answered by AI

Has the FDA okayed treatment that is given through a computer?

"While Phase 2 trials have not yet shown efficacy, the available data supports that this computer-delivered naming treatment is safe."

Answered by AI

Are there precedent studies for this Computer-delivered naming treatment?

"At this moment, there are 27 ongoing studies related to the efficacy of computer-delivered naming treatment. 5 of those studies are currently in phase 3. A majority of these research projects are situated in Cincinnati, Ohio; however, there are 50 clinical trial sites across the United States."

Answered by AI

In how many different hospitals is this medical study being run today?

"There are 4 primary sites where this research project is taking place. Reisterstown, Baltimore and Columbia in Maryland as well as another location. Investigators recommend that patients select the site which is closest to them to cut down on required travel."

Answered by AI

How many people are a part of this clinical research?

"That is accurate. The clinicaltrials.gov website has information showing that this research project, which was first made available on 7/18/2021, is currently seeking participants. 88 individuals are needed for the study to be conducted at 4 different locations."

Answered by AI

Could I potentially be a candidate for this research project?

"This trial is for 88 people with aphasia that are 18-99 years old. The most notable criteria candidates should meet are as follows: being age 18 or older, pre-morbidly right-handed by self-report, within 5 days of onset of stroke, having an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised (Aphasia Quotient < 93.8), and sustaining an acute ischemic left hemisphere stroke."

Answered by AI