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Modulating Intensity and Dosage of Aphasia Scripts (MIDAS)

Primary Purpose

Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Script Training
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Stroke, Speech and Language Therapy, Speech and Language Treatment, Communication Disorders, Language Disorders

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilitylabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Distributed, Short Script

Distributed, Long Script

Massed, Short Script

Massed, Long Script

Arm Description

Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.

Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.

Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.

Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Generalization - Conversation with a communication partner about the topic of the trained script
Number of correct information units produced during conversation with communication partner (speech-language pathologist) about the broad topic of the trained script.
Acquisition of trained script - Accuracy
Percent accurate words produced on trained script during oral reading probes provided via the computer program.
Acquisition of trained script - Rate
Rate of production (words per minute) of trained script during oral reading probes provided via the computer program.

Full Information

First Posted
October 23, 2019
Last Updated
June 22, 2023
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University, University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT04138940
Brief Title
Modulating Intensity and Dosage of Aphasia Scripts
Acronym
MIDAS
Official Title
Modulating Stimuli Intensity to Improve Clinical Outcomes in Aphasia Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University, University of Colorado, Boulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Stroke, Speech and Language Therapy, Speech and Language Treatment, Communication Disorders, Language Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distributed, Short Script
Arm Type
Experimental
Arm Description
Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.
Arm Title
Distributed, Long Script
Arm Type
Experimental
Arm Description
Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.
Arm Title
Massed, Short Script
Arm Type
Experimental
Arm Description
Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.
Arm Title
Massed, Long Script
Arm Type
Experimental
Arm Description
Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.
Intervention Type
Behavioral
Intervention Name(s)
Script Training
Intervention Description
Participant uses a computer program to practice scripts with a virtual therapist.
Primary Outcome Measure Information:
Title
Generalization - Conversation with a communication partner using the lines of the trained script
Description
Number of correct information units produced during conversation with communication partner (speech-language pathologist) using the lines of the trained script.
Time Frame
Change from baseline to immediately post treatment
Secondary Outcome Measure Information:
Title
Generalization - Conversation with a communication partner about the topic of the trained script
Description
Number of correct information units produced during conversation with communication partner (speech-language pathologist) about the broad topic of the trained script.
Time Frame
Change from baseline to immediately post treatment
Title
Acquisition of trained script - Accuracy
Description
Percent accurate words produced on trained script during oral reading probes provided via the computer program.
Time Frame
Change from baseline to immediately post treatment
Title
Acquisition of trained script - Rate
Description
Rate of production (words per minute) of trained script during oral reading probes provided via the computer program.
Time Frame
Change from baseline to immediately post treatment
Other Pre-specified Outcome Measures:
Title
Maintenance - Conversation with a communication partner using the lines of the trained script
Description
Number of correct information units produced during conversation with communication partner (speech-language pathologist) using the lines of the trained script.
Time Frame
Change from baseline to six weeks post treatment.
Title
Maintenance - Conversation with a communication partner about the topic of the trained script
Description
Number of correct information units produced during conversation with communication partner (speech-language pathologist) about the broad topic of the trained script.
Time Frame
Change from baseline to six weeks post treatment.
Title
Maintenance of trained script - Accuracy
Description
Percent accurate words produced on trained script during oral reading probes provided via the computer program.
Time Frame
Change from baseline to six weeks post treatment
Title
Maintenance of trained script - Rate
Description
Rate of production (words per minute) of trained script during oral reading probes provided via the computer program.
Time Frame
Change from baseline to six weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Kinsey, MS, CCC-SLP
Phone
312-238-6163
Email
lkinsey@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD, CCC-SLP
Organizational Affiliation
Shirley Ryan Abilitylab, Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan Abilitylab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Kinsey, MS, CCC-SLP
Phone
312-238-6163
Email
lkinsey@sralab.org
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD, CCC-SLP

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.sralab.org/research/labs/center-aphasia-research-treatment
Description
Center for Aphasia Research & Treatment

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Modulating Intensity and Dosage of Aphasia Scripts

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