- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04138940
Modulating Intensity and Dosage of Aphasia Scripts (MIDAS)
Modulating Stimuli Intensity to Improve Clinical Outcomes in Aphasia Treatment
Study Overview
Detailed Description
Determining the optimal intensity of treatment is essential to the design and implementation of any treatment program for aphasia. Yet, treatment intensity is a complex construct and information on the variables modulating it remain ambiguous and limited. Studies reported in the neuroscience and clinical literature support the need for intensive treatment to induce long-term neuroplastic changes while the cognitive psychology literature suggests that learning is best maintained with distributed schedules. A few studies have looked at dose parameters for single word naming tasks, but there is limited evidence regarding dose parameters for treatments that focus on training the production of larger units, such as sentences or even connected discourse. One approach that is frequently used clinically and has evidence for its efficacy is script training. Little is currently known regarding the optimum dose of script training (i.e., the number of repetitions over time of each sentence within the script) that is required to promote the best outcomes.
This study investigates the effects of modulating stimulus variables, specifically stimulus practice distribution and stimulus repetition. We use a baseline script treatment that has experimental support regarding its efficacy, and that allows the manipulation of these variables. To ensure independence and fidelity, treatment is provided in a controlled computer environment (desktop and tablet). To avoid clinician-related variables such as expertise and personality factors that may influence treatment, sentences are modeled during treatment by an anthropomorphic agent with high visual speech intelligibility and affective expressions.
With regard to "best outcomes", generalization is the ultimate goal of any treatment approach. Therefore, the primary outcome is a generalization measure of conversation. Secondary measures address short-term acquisition, longer-term maintenance, and stimulus and response generalization for assessing gain over baseline, differential effects, and interactions. A mobile-connected wireless wearable laryngeal sensor allows tracking of talk time at home and in the community as a measure of treatment effectiveness and transfer. For privacy, it does not record audio.
Results and computational models of learning (generalization, short-term acquisition, and longer-term maintenance) will contribute new evidence to fill critical gaps in current scientific understanding regarding the effectiveness and clinical application of aphasia treatment approaches. More generally, findings will help to inform clinical practice and treatment of neurologic communication disorders; the virtual clinician guided intervention that the proposal develops has the potential to reduce costly clinician-client time otherwise required for long-term rehabilitation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Kinsey, MS, CCC-SLP
- Phone Number: 312-238-6163
- Email: lkinsey@sralab.org
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Shirley Ryan AbilityLab
-
Contact:
- Laura Kinsey, MS, CCC-SLP
- Phone Number: 312-238-6163
- Email: lkinsey@sralab.org
-
Principal Investigator:
- Leora Cherney, PhD, CCC-SLP
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Distributed, Short Script
Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.
|
Participant uses a computer program to practice scripts with a virtual therapist.
|
Experimental: Distributed, Long Script
Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.
|
Participant uses a computer program to practice scripts with a virtual therapist.
|
Experimental: Massed, Short Script
Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.
|
Participant uses a computer program to practice scripts with a virtual therapist.
|
Experimental: Massed, Long Script
Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.
|
Participant uses a computer program to practice scripts with a virtual therapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalization - Conversation with a communication partner using the lines of the trained script
Time Frame: Change from baseline to immediately post treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalization - Conversation with a communication partner about the topic of the trained script
Time Frame: Change from baseline to immediately post treatment
|
Number of correct information units produced during conversation with communication partner (speech-language pathologist) about the broad topic of the trained script.
|
Change from baseline to immediately post treatment
|
Acquisition of trained script - Accuracy
Time Frame: Change from baseline to immediately post treatment
|
Percent accurate words produced on trained script during oral reading probes provided via the computer program.
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Change from baseline to immediately post treatment
|
Acquisition of trained script - Rate
Time Frame: Change from baseline to immediately post treatment
|
Rate of production (words per minute) of trained script during oral reading probes provided via the computer program.
|
Change from baseline to immediately post treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance - Conversation with a communication partner using the lines of the trained script
Time Frame: Change from baseline to six weeks post treatment.
|
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 six weeks post treatment.
|
Maintenance - Conversation with a communication partner about the topic of the trained script
Time Frame: Change from baseline to six weeks post treatment.
|
Number of correct information units produced during conversation with communication partner (speech-language pathologist) about the broad topic of the trained script.
|
Change from baseline to six weeks post treatment.
|
Maintenance of trained script - Accuracy
Time Frame: Change from baseline to six weeks post treatment
|
Percent accurate words produced on trained script during oral reading probes provided via the computer program.
|
Change from baseline to six weeks post treatment
|
Maintenance of trained script - Rate
Time Frame: Change from baseline to six weeks post treatment
|
Rate of production (words per minute) of trained script during oral reading probes provided via the computer program.
|
Change from baseline to six weeks post treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leora Cherney, PhD, CCC-SLP, Shirley Ryan Abilitylab, Northwestern University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00209618
- 1R01DC016979-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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