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Intention Treatment for Aphasia
N/A
Recruiting
Led By Amy D. Rodriguez, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of word retrieval deficits
Diagnosis of aphasia
Must not have
Severe apraxia of speech or dysarthria
Clinically significant depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months; change from baseline to 3 weeks (post massed-int) or 12 weeks (post distributed-int), change at 3 months post-treatment, change at 6 months post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating a new word retrieval treatment for Veterans with aphasia caused by stroke, to see if it is more effective than the current standard of care.
Who is the study for?
This trial is for Veterans who primarily speak English, have aphasia with difficulty finding words after a stroke in the left side of the brain, and can follow two-step commands. It's not for those with implanted medical devices or metal in their bodies, severe speech muscle control issues, or major depression.
What is being tested?
The study tests a new word retrieval treatment for aphasia following a stroke. Researchers aim to find out how intense this therapy should be and what factors predict success in improving language skills among Veterans.
What are the potential side effects?
Since this is a non-drug intervention focusing on language therapy post-stroke, traditional medication side effects are not expected. However, participants may experience fatigue or frustration during intensive language exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I struggle to find the right words when speaking.
Select...
I have been diagnosed with aphasia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe difficulty speaking clearly.
Select...
I have been diagnosed with severe depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study study completion, an average of 6 months; change from baseline to 3 weeks (post m-int) or 12 weeks (post d-int), change at 3 months post-treatment, change at 6 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study study completion, an average of 6 months; change from baseline to 3 weeks (post m-int) or 12 weeks (post d-int), change at 3 months post-treatment, change at 6 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Boston Naming Test
Brief Visuospatial Memory Test-Revised
Delis?Kaplan Executive Function System (D-KEFS) Sorting
+8 moreSecondary study objectives
Delis?Kaplan Executive Function System (D-KEFS) Trails
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Distributed Intention Treatment (distributed-INT)Active Control1 Intervention
Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks.
Group II: Massed Intention Treatment (massed-INT)Active Control1 Intervention
Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,427,248 Total Patients Enrolled
Amy D. Rodriguez, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
2 Previous Clinical Trials
41 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have metal implants, devices, or severe fear of tight spaces.I struggle to find the right words when speaking.I can understand and follow two-step commands.I have severe difficulty speaking clearly.It's been 6 months since my stroke, which was in the left side of my brain.I have been diagnosed with aphasia.I have been diagnosed with severe depression.
Research Study Groups:
This trial has the following groups:- Group 1: Distributed Intention Treatment (distributed-INT)
- Group 2: Massed Intention Treatment (massed-INT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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