Escitalopram and Language Intervention for Subacute Aphasia



Status:Not yet recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 99
Updated:3/8/2019
Start Date:February 2020
End Date:February 2024
Contact:Argye Hillis-Trupe, MD
Email:argye@jhmi.edu
Phone:(410) 614-2381

Use our guide to learn which trials are right for you!

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).

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.

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
We found this trial at
1
site
Baltimore, Maryland 21287
Phone: 410-614-9807
?
mi
from
Baltimore, MD
Click here to add this to my saved trials