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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately post treatment
Awards & highlights

MIDAS Trial 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.Check my eligibility
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).See study design
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.

MIDAS 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.

MIDAS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Generalization - Conversation with a communication partner using the lines of the trained script
Secondary outcome measures
Acquisition of trained script - Accuracy
Acquisition of trained script - Rate
Generalization - Conversation with a communication partner about the topic of the trained script
Other outcome measures
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

MIDAS 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
1,586 Previous Clinical Trials
917,156 Total Patients Enrolled
11 Trials studying Aphasia
1,028 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,376 Total Patients Enrolled
37 Trials studying Aphasia
2,694 Patients Enrolled for Aphasia
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,817 Total Patients Enrolled
9 Trials studying Aphasia
326 Patients Enrolled for Aphasia

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

Frequently Asked Questions

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

Are participants being recruited for this trial currently?

"Affirmative. Clinicaltrials.gov reveals that this research is still recruiting volunteers, which it first did on September 21st 2020 and most recently updated on June 15th 2022. Ninety-five participants are needed from one trial site."

Answered by AI

What is the scope of participation for this clinical trial?

"Indeed, clinicaltrials.gov provides evidence that this trial is still enrolling participants. It was first uploaded on September 21st 2020 and updated June 15th 2022 with 95 patients needed to complete the study from one site."

Answered by AI

Who else is applying?

What site did they apply to?
Shirley Ryan Abilitylab
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Kristie has been working through speech therapy since being release from the ICU in Feb 2023. Although her speech has improved some comparatively , she still struggles with basic communication.
PatientReceived 2+ prior treatments
~15 spots leftby Dec 2024