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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Recruiting
        • Purdue University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Sentence training
Participants will be trained to read, make, and recall sentences during each session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
From baseline up to 1-week post training or 2-month post treatment
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
Comprehension accuracy (percent correct)
From baseline up to 1-week post training or 2-month post treatment
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
Changes in eye fixations to the target picture
From baseline up to 1-week post training or 2-month post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Connected speech production - story retell
Time Frame: From baseline up to 2-month post treatment
Increased production of complex utterances as measured by proportion of sentence-level utterances out of all utterances
From baseline up to 2-month post treatment
Connected speech production - picture description
Time Frame: From baseline up to 2-month post treatment
Increased production of complex utterances as measured by proportion of sentence-level utterances out of all utterances
From baseline up to 2-month post treatment
Production of untrained sentences
Time Frame: From baseline up to 2-month post treatment
Production accuracy (percent correct)
From baseline up to 2-month post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Diego
Temple University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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