AphasiaNCT05415501
Sentence Production Training in Aphasia
A study testing Sentence training in people with Aphasia, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- Sentence training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe apraxia of speech
- Other neurological conditions affecting communication (e.g., dementia)
- Uncontrolled psychiatric/psychological conditions affecting thinking and communication
- Active alcohol/substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 47907
Jiyeon Lee, 765-494-3810, lee1704@purdue.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Aphasia
- Being tested
- Sentence training
- Keywords
- aphasia training, aphasia treatment, sentences, grammar
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentence trainingBehavioural
Participants will be trained to read, make, and recall sentences during each session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sentence training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of target sentences on action description pictures
Production accuracy (percent correct)
Measured: 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)
Measured: 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
Measured: From baseline up to 1-week post training or 2-month post treatment
Secondary outcomes (3)
Production of untrained sentences
Production accuracy (percent correct)
Measured: From baseline up to 2-month post treatment
Connected speech production - story retell
Increased production of complex utterances as measured by proportion of sentence-level utterances out of all utterances
Measured: From baseline up to 2-month post treatment
Connected speech production - picture description
Increased production of complex utterances as measured by proportion of sentence-level utterances out of all utterances
Measured: From baseline up to 2-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Aug 2021
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, University of California, San Diego
- Responsible party
- Principal investigator, Ji Yeon Lee, Purdue University
- Investigators
- Jiyeon Lee, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415501
- Sponsor's protocol ID
- IRB-2021-659
- Status last verified
- Dec 2024
- First submitted
- 16 May 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Priming as a Treatment Component in Aphasia
- ClinicalTrials.gov ID
- NCT05415501
- Acronym / sponsor ID
- IRB-2021-659
- Conditions
- Aphasia
- Keywords
- aphasia training, aphasia treatment, sentences, grammar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Temple University, University of California, San Diego
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 13 Jun 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Structural priming training | Experimental | Behavioral: Sentence trainingParticipants 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Severe apraxia of speech
- Other neurological conditions affecting communication (e.g., dementia)
- Uncontrolled psychiatric/psychological conditions affecting thinking and communication
- Active alcohol/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 |
|---|---|---|
| Sentence trainingParticipants will be trained to read, make, and recall sentences during each session. | Behavioural | Structural priming training |
Primary outcome
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)
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)
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
3 secondary outcomes
Production of untrained sentences
Time frame: From baseline up to 2-month post treatment
Connected speech production - story retell
Time frame: From baseline up to 2-month post treatment
Connected speech production - picture description
Time frame: From baseline up to 2-month post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Aphasia
Enrolling by invitation
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Aphasia
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
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Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
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.
Jiyeon Lee, PhD principal investigator
Purdue 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 Sentence training in people with Aphasia, run by Purdue University 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyeon Lee, PhD (7654943810, lee1704@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of target sentences on action description pictures (time frame: From baseline up to 1-week post training or 2-month post treatment). The study lists 3 primary outcomes in all. 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 18 Dec 2024.