Modulating Intensity and Dosage of Aphasia Scripts
MIDAS
Modulating Stimuli Intensity to Improve Clinical Outcomes in Aphasia Treatment
2 other identifiers
interventional
85
1 country
1
Brief Summary
The purpose of this study is to evaluate how changing conditions of speech-language treatment (namely, amount of repetition and distribution of practice schedule) affects the language outcome of participants with aphasia following a stroke. Using a computer based speech and language therapy program, participants will practice conversational scripts that are either short or long. Participants will practice for either 2 weeks (5 days a week) or for 5 weeks (2 days a week).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2024
CompletedMay 28, 2025
May 1, 2025
4.2 years
October 23, 2019
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Generalization - Conversation with a communication partner using the lines of the trained script
Number of correct information units produced during conversation with communication partner (speech-language pathologist) using the lines of the trained script.
Change from baseline to immediately post treatment
Secondary Outcomes (3)
Generalization - Conversation with a communication partner about the topic of the trained script
Change from baseline to immediately post treatment
Acquisition of trained script - Accuracy
Change from baseline to immediately post treatment
Acquisition of trained script - Rate
Change from baseline to immediately post treatment
Other Outcomes (4)
Maintenance - Conversation with a communication partner using the lines of the trained script
Change from baseline to six weeks post treatment.
Maintenance - Conversation with a communication partner about the topic of the trained script
Change from baseline to six weeks post treatment.
Maintenance of trained script - Accuracy
Change from baseline to six weeks post treatment
- +1 more other outcomes
Study Arms (4)
Distributed, Short Script
EXPERIMENTALParticipant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.
Distributed, Long Script
EXPERIMENTALParticipant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.
Massed, Short Script
EXPERIMENTALParticipant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.
Massed, Long Script
EXPERIMENTALParticipant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.
Interventions
Participant uses a computer program to practice scripts with a virtual therapist.
Eligibility Criteria
You may qualify if:
- Men or women with diagnosis of aphasia
- Left-hemisphere stroke
- Aphasia Quotient score between 40-80 on the Western Aphasia Battery-Revised
- At least 6 months post stroke
- Completed at least eighth grade education
- Premorbidly literate in English
- Visual acuity no worse than 20/100 corrected in the better eye
- Auditory acuity no worse than 30 dB HL on pure tone testing, aided in better ear
- Not receiving speech-language therapy at the time of study
You may not qualify if:
- 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
- Any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered
- Active substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirley Ryan AbilityLablead
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
- Northwestern Universitycollaborator
- University of Colorado, Bouldercollaborator
Study Sites (1)
Shirley Ryan Abilitylab
Chicago, Illinois, 60611, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leora Cherney, PhD, CCC-SLP
Shirley Ryan Abilitylab, Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Single (Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 25, 2019
Study Start
September 21, 2020
Primary Completion
December 4, 2024
Study Completion
December 4, 2024
Last Updated
May 28, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share