NCT05415501

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

4.8 years

First QC Date

May 16, 2022

Last Update Submit

December 14, 2024

Conditions

Keywords

aphasia trainingaphasia treatmentsentencesgrammar

Outcome Measures

Primary Outcomes (3)

  • Production of target sentences on action description pictures

    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

    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

    Changes in eye fixations to the target picture

    From baseline up to 1-week post training or 2-month post treatment

Secondary Outcomes (3)

  • Production of untrained sentences

    From baseline up to 2-month post treatment

  • Connected speech production - story retell

    From baseline up to 2-month post treatment

  • Connected speech production - picture description

    From baseline up to 2-month post treatment

Study Arms (1)

Structural priming training

EXPERIMENTAL

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

Interventions

Participants will be trained to read, make, and recall sentences during each session.

Structural priming training

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe apraxia of speech
  • Other neurological conditions affecting communication (e.g., dementia)
  • Uncontrolled psychiatric/psychological conditions affecting thinking and communication
  • Active alcohol/substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jiyeon Lee, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiyeon Lee, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 16, 2022

First Posted

June 13, 2022

Study Start

August 1, 2021

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Starting 6 months after publication
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.

Locations