AphasiaMIDASNCT04138940
Modulating Intensity and Dosage of Aphasia Scripts
A study testing Script Training in people with Aphasia, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Script Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulating Stimuli Intensity to Improve Clinical Outcomes in Aphasia Treatment
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).
Read the 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.
- Conditions
- Aphasia
- Being tested
- Script Training
- Keywords
- Stroke, Speech and Language Therapy, Speech and Language Treatment, Communication Disorders, Language Disorders
- Medical subject headings
- Aphasia, Stroke, Communication Disorders, Speech, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Script TrainingBehavioural
Participant uses a computer program to practice scripts with a virtual therapist.
| Study group | Role | What they receive |
|---|---|---|
| Distributed, Short Script | Experimental | Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script. Receives: Behavioral: Script Training |
| Distributed, Long Script | Experimental | Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script. Receives: Behavioral: Script Training |
| Massed, Short Script | Experimental | Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script. Receives: Behavioral: Script Training |
| Massed, Long Script | Experimental | Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script. Receives: Behavioral: Script Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to immediately post treatment
Secondary outcomes (3)
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.
Measured: Change from baseline to immediately post treatment
Acquisition of trained script - Accuracy
Percent accurate words produced on trained script during oral reading probes provided via the computer program.
Measured: Change from baseline to immediately post treatment
Acquisition of trained script - Rate
Rate of production (words per minute) of trained script during oral reading probes provided via the computer program.
Measured: Change from baseline to immediately post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start21 Sep 2020
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University, University of Colorado, Boulder
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
- Investigators
- Leora Cherney, PhD, CCC-SLP, Principal investigator, Shirley Ryan Abilitylab, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138940
- Sponsor's protocol ID
- STU00209618
- Other IDs
- 1R01DC016979-01A1
- Acronym
- MIDAS
- Status last verified
- May 2025
- First submitted
- 23 Oct 2019
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Stimuli Intensity to Improve Clinical Outcomes in Aphasia Treatment
- ClinicalTrials.gov ID
- NCT04138940
- Acronym / sponsor ID
- MIDAS / STU00209618
- Conditions
- Aphasia
- Keywords
- Stroke, Speech and Language Therapy, Speech and Language Treatment, Communication Disorders, Language Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Northwestern University, University of Colorado, Boulder
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Distributed, Short Script | Experimental | Behavioral: Script TrainingParticipant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script. |
| Distributed, Long Script | Experimental | Behavioral: Script TrainingParticipant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script. |
| Massed, Short Script | Experimental | Behavioral: Script TrainingParticipant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script. |
| Massed, Long Script | Experimental | Behavioral: Script TrainingParticipant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Script TrainingParticipant uses a computer program to practice scripts with a virtual therapist. | Behavioural | Distributed, Long Script, Distributed, Short Script, Massed, Long Script, Massed, Short Script |
Primary outcome
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.
3 secondary outcomes
Generalization - Conversation with a communication partner about the topic of the trained script
Time frame: Change from baseline to immediately post treatment
Acquisition of trained script - Accuracy
Time frame: Change from baseline to immediately post treatment
Acquisition of trained script - Rate
Time frame: Change from baseline to immediately post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Center for Aphasia Research \& TreatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
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Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leora Cherney, PhD, CCC-SLP principal investigator
Shirley Ryan Abilitylab, Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Script Training in people with Aphasia, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalization - Conversation with a communication partner using the lines of the trained script (time frame: Change from baseline to immediately post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.