Computer-delivered naming treatment for Aphasia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Aphasia+1 MoreComputer-delivered naming treatment - Behavioral
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Aphasia
  • Stroke

Treatment Effectiveness

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Baseline, 1 week after computer-delivered naming treatment

2 months after enrollment
Post-stroke quality of life as assessed by Stroke Impact Scale (SIS)
Stroke paresis severity as assessed by right arm strength
Week 1
Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella"
Change in Philadelphia Naming Test accuracy score
Change in Philadelphia Naming Test short-form accuracy score
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"
Change in new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Depression as assessed by Patient Health Questionnaire (PHQ-9)
Language production as assessed by Morphosyntactic Generation (MorGen) Test
Post-stroke level of disability as assessed by modified Rankin Scale (mRS)
Stroke paresis severity as assessed by right hand dexterity
Stroke paresis severity as assessed by right hand strength
Week 5
Language production as assessed by content units included in picture description of "Cookie Theft"
Language production as assessed by lexical features of discourse in "Cookie Theft" picture description
Language production as assessed by rate of syllables per content unit produced in "Cookie Theft" picture description
Week 20
Stroke severity as assessed by NIH Stroke Scale (NIHSS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Naming Treatment + Escitalopram
1 of 2
Naming Treatment + Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

88 Total Participants · 2 Treatment Groups

Primary Treatment: Computer-delivered naming treatment · Has Placebo Group · Phase 2

Naming Treatment + EscitalopramExperimental Group · 2 Interventions: Computer-delivered naming treatment, Escitalopram 10mg · Intervention Types: Behavioral, Drug
Naming Treatment + PlaceboPlaceboComparator Group · 2 Interventions: Computer-delivered naming treatment, Placebo · Intervention Types: Behavioral, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week after computer-delivered naming treatment

Who is running the clinical trial?

University of South CarolinaOTHER
177 Previous Clinical Trials
93,370 Total Patients Enrolled
6 Trials studying Aphasia
533 Patients Enrolled for Aphasia
University of California, IrvineOTHER
500 Previous Clinical Trials
1,881,364 Total Patients Enrolled
Medical University of South CarolinaOTHER
838 Previous Clinical Trials
5,378,454 Total Patients Enrolled
4 Trials studying Aphasia
328 Patients Enrolled for Aphasia
Johns Hopkins UniversityLead Sponsor
2,074 Previous Clinical Trials
31,017,636 Total Patients Enrolled
12 Trials studying Aphasia
976 Patients Enrolled for Aphasia
Argye Hillis-Trupe, MDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18 - 99 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you are not age 18 or older, you cannot participate in this study.
You are right-handed.\n
You have sustained an acute ischemic left hemisphere stroke.

Who else is applying?

What state do they live in?
North Carolina100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References