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Behavioral Intervention

Script Training for Aphasia (MIDAS Trial)

N/A
Recruiting
Led By Leora Cherney, PhD, CCC-SLP
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women with diagnosis of aphasia
Left-hemisphere stroke
Must not have
Any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how different amounts of repetition and different practice schedules affects people with aphasia's language ability following a stroke.

Who is the study for?
This trial is for men and women who have aphasia after a left-hemisphere stroke. They should be at least 6 months post-stroke, with an Aphasia Quotient score of 40-80 on the Western Aphasia Battery-Revised. Participants must have completed eighth grade, be literate in English, not currently receiving speech therapy, and have adequate vision and hearing. Those with active substance abuse, other neurological conditions affecting cognition/speech or significant psychiatric history are excluded.
What is being tested?
The study tests how different speech-language treatment schedules affect language recovery in aphasic patients post-stroke. Using computer-based therapy to practice conversational scripts that vary in length, participants will follow either a high-intensity schedule (5 days/week for 2 weeks) or a low-intensity schedule (2 days/week for 5 weeks).
What are the potential side effects?
Since this intervention involves non-invasive script training using computer programs there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with aphasia.
Select...
I had a stroke affecting the left side of my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any brain conditions like Parkinson's or Alzheimer's that affect my thinking or speech.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to immediately post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Generalization - Conversation with a communication partner using the lines of the trained script
Secondary study objectives
Acquisition of trained script - Accuracy
Acquisition of trained script - Rate
Generalization - Conversation with a communication partner about the topic of the trained script
Other study objectives
Maintenance - Conversation with a communication partner about the topic of the trained script
Maintenance - Conversation with a communication partner using the lines of the trained script
Maintenance of trained script - Accuracy
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Massed, Short ScriptExperimental Treatment1 Intervention
Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.
Group II: Massed, Long ScriptExperimental Treatment1 Intervention
Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.
Group III: Distributed, Short ScriptExperimental Treatment1 Intervention
Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.
Group IV: Distributed, Long ScriptExperimental Treatment1 Intervention
Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,652 Previous Clinical Trials
961,420 Total Patients Enrolled
11 Trials studying Aphasia
1,084 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
182,202 Total Patients Enrolled
39 Trials studying Aphasia
2,729 Patients Enrolled for Aphasia
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
17,830 Total Patients Enrolled
9 Trials studying Aphasia
326 Patients Enrolled for Aphasia
University of Colorado, BoulderOTHER
124 Previous Clinical Trials
29,320 Total Patients Enrolled
2 Trials studying Aphasia
51 Patients Enrolled for Aphasia
Leora Cherney, PhD, CCC-SLPPrincipal Investigator - Shirley Ryan Abilitylab, Northwestern University
Shirley Ryan AbilityLab

Media Library

Modulating Intensity and Dosage of Aphasia Scripts (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04138940 — N/A
Aphasia Research Study Groups: Distributed, Short Script, Massed, Long Script, Distributed, Long Script, Massed, Short Script
Aphasia Clinical Trial 2023: Modulating Intensity and Dosage of Aphasia Scripts Highlights & Side Effects. Trial Name: NCT04138940 — N/A
Modulating Intensity and Dosage of Aphasia Scripts (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04138940 — N/A
~0 spots leftby Dec 2024
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