- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415501
Sentence Production Training in Aphasia
December 14, 2024 updated by: Ji Yeon Lee, Purdue University
Structural Priming as a Treatment Component in Aphasia
This project focuses on developing a novel treatment for sentence production and comprehension in aphasia, using implicit priming.
First set of experiments will aim examine which learning conditions are most effective in creating maximal training gains.
Then, in a later study, the investigators will develop and test the efficacy of a novel treatment study based on findings from the first set of the studies.
Study Overview
Detailed Description
Over five years, the investigators will conduct a series of studies to develop a novel intervention strategy for improving sentence production and comprehension in persons with aphasia.
Specifically, the investigators will use implicit learning of grammar as a novel facilitator for language recovery in aphasia.
The planned studies seek to test the hypothesis that implicit learning alters the central language system in PWA, creating lasting and generalized improvements in both sentence production and comprehension.
Aim 1 will determine the extent to which different learning conditions modulate immediate and long-term improvement in sentence production.
The investigators integrate multiple theories of language learning and apply them to make predictions about the trajectory of priming-induced learning in PWA.
In Aim 2, using a set of eyetracking and sentence comprehension tasks, it will be investigated whether the effects of priming in production generalize to off-line (accuracy) and on-line (eye fixations) sentence comprehension and determine which learning conditions result in greater cross-modality generalization.
In Aim 3, the investigators will develop and establish Phase I efficacy data of an implicit priming treatment, incorporating the crucial learning conditions supporting maximal retention from Aims 1 and 2. The project will recruit both individuals with aphasia and without aphasia.
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiyeon Lee, PhD
- Phone Number: 7654943810
- Email: lee1704@purdue.edu
Study Contact Backup
- Name: Jiyeon Lee
- Phone Number: 7654943810
- Email: lee1704@purdue.edu
Study Locations
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Indiana
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West Lafayette, Indiana, United States, 47907
- Recruiting
- Purdue University
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Contact:
- Jiyeon Lee
- Phone Number: 765-494-3810
- Email: lee1704@purdue.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals with post-stroke aphasia
- At least 6 months post-onset of eft hemisphere stroke
- Native speaker of English
- Normal or corrected to normal hearing and vision
- High-school educated
- Difficulty communicating in sentences, with some ability to use words independently
Exclusion Criteria:
- Severe apraxia of speech
- Other neurological conditions affecting communication (e.g., dementia)
- Uncontrolled psychiatric/psychological conditions affecting thinking and communication
- Active alcohol/substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Structural priming training
Participants will be enrolled in 3 sessions of structural priming training (for experiment 1-3) or up to 15 treatment sessions (for experiment 4).
Each session will be about 2 hour long, consisting of a set of tasks, including repeating, making, and remembering various types of sentences.
In experiment 1-3, each participant will receive two different experimental priming conditions that are being compared within each session.
In experiment 4, participants will receive a structural priming treatment in a single-subject design.
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Participants will be trained to read, make, and recall sentences during each session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Production of target sentences on action description pictures
Time Frame: From baseline up to 1-week post training or 2-month post treatment
|
Production accuracy (percent correct)
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From baseline up to 1-week post training or 2-month post treatment
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Comprehension of target sentences in a sentence-to-picture matching task
Time Frame: From baseline up to 1-week post training or 2-month post treatment
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Comprehension accuracy (percent correct)
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From baseline up to 1-week post training or 2-month post treatment
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Real-time comprehension of target sentences in a sentence-to-picture matching task
Time Frame: From baseline up to 1-week post training or 2-month post treatment
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Changes in eye fixations to the target picture
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From baseline up to 1-week post training or 2-month post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Connected speech production - story retell
Time Frame: From baseline up to 2-month post treatment
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Increased production of complex utterances as measured by proportion of sentence-level utterances out of all utterances
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From baseline up to 2-month post treatment
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Connected speech production - picture description
Time Frame: From baseline up to 2-month post treatment
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Increased production of complex utterances as measured by proportion of sentence-level utterances out of all utterances
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From baseline up to 2-month post treatment
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Production of untrained sentences
Time Frame: From baseline up to 2-month post treatment
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Production accuracy (percent correct)
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From baseline up to 2-month post treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiyeon Lee, PhD, Purdue University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Study Registration Dates
First Submitted
May 16, 2022
First Submitted That Met QC Criteria
June 10, 2022
First Posted (Actual)
June 13, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 14, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2021-659
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We plan to share de-identified individual data with other researchers upon request.
Other study materials (e.g., analytic code) will be made available via Open Science Forum.
We will also make study-specific data and materials available for journal publications as supplemental materials, as relevant.
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
Researchers of OSF will access the study materials or data made available via OSF.
Deidentified individual data can also be shared with other researchers upon requests and the PI will review each request.
Other supporting materials such as study stimuli or protocols will be shared with other researchers upon request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.