AphasiaPhase 2NCT05653440
Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia
A Phase 2 study testing Accuracy-maximized condition, Effort-maximized condition and Effort-accuracy balanced condition in people with Aphasia and Stroke, run by University of Pittsburgh at 1 site in United States.
Trial summary
Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Accuracy-maximized condition, Effort-maximized condition and Effort-accuracy balanced condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 31 Jan 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Existing diagnosis of chronic (>6 months) aphasia subsequent to left hemisphere ischemic or hemorrhagic stroke.
- Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.
Who cannot join
- History of other acquired or progressive neurological disease.
- Significant language comprehension impairments
- Unmanaged drug / alcohol dependence.
- Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.
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
Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
William Evans, PhD, 412-383-6943, will.evans@pitt.edu
William Evans, PhD
About this study
Official title: Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 1: Balancing Effortful and Errorless Learning Via Adaptive Naming Deadlines)
Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life.
This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines.
Read the detailed description
Study 1: Evaluate the benefits of balancing effortful and errorless learning via adaptive naming deadlines.
- Study design: The investigators will enroll 30 people with aphasia in a randomized within-subjects crossover design comparing trained words in three retrieval conditions. Stimuli will be balanced across conditions using an established item-response theory algorithm developed by Dr. Hula (consultant). Participants will receive 8 sessions of treatment per condition (2x/ week for 4 weeks), with probes administered at baseline and 1 week, 3 months, and 6 months post-treatment. Condition treatment order will be randomly assigned and counter- balanced across participants. In total, Sub-study 1 includes typically 3-4 (but up to 6) assessment sessions, 24 treatment sessions, and 24 baseline and follow-up probe assessment sessions per participant over an approximately 10-month period, but up to 18 months. Data collection will take place at the Language Rehabilitation and Cognition Laboratory (LRCL) at the University of Pittsburgh, in participants' homes, or in private rooms in public spaces (e.g. libraries, community centers).
- Participants: The investigators will recruit 30 male and female community-dwelling people with aphasia >6 months post- onset of aphasia due to left-hemisphere ischemic or hemorrhagic stroke. Aphasia diagnosis will be confirmed by Comprehensive Aphasia Test (CAT) performance and medical history. Investigators will exclude potential participants with a history of other acquired or progressive neurological disease, significant language comprehension impairments, unmanaged drug/alcohol dependence, and severe diagnosed mood or behavioral disorders that require specialized mental health interventions.
- Assessment Procedures: Participants will be tested on a comprehensive initial battery of standardized assessments characterizing their aphasia severity and overall language profile, naming and discourse abilities, semantic processing, verbal short-term and working memory at baseline. Patient-reported measures of treatment motivation and pre-post changes in communication effectiveness will also be measured in response to each treatment condition. These tests will ensure that our participants well-characterized from a behavioral perspective, and measures will be used in secondary analyses and model development exploring predictors of treatment response.
- Treatment description: Each training trial will consist of a fixation cross and picture presentation. A repetition cue (audio recording and written from of the target) will be provided to participants based on the deadlines described above. Participants will be instructed to name the picture and indicate when they have given their final answer via key press, with responses also timed and scored by clinician key press. In the errorless condition, they will be instructed to repeat the target, while in the other conditions they will be asked to try to name the picture independently before they hear the target. Once they have indicated that they have provided their final answer, they will receive accuracy feedback on the computer screen based on clinician scoring. To maximize the clinical relevance of this study, investigators will control total amount of treatment time (8 hours) between conditions, instead of controlling the total number of trials. This is because many more trials can be completed per hour in the errorless or balanced conditions compared to the effort-maximized condition, and investigators want study outcomes to practically inform clinicians on how best to spend limited treatment time.
- Being tested
- Accuracy-maximized condition, Effort-maximized condition, Effort-accuracy balanced condition
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy-maximized conditionBehavioural
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized conditionBehavioural
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced conditionBehavioural
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
| Study group | Role | What they receive |
|---|---|---|
| Effort-maximized, then accuracy-maximized, then effort-accuracy balanced | Experimental | All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. Receives: Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition |
| Effort-maximized, then effort-accuracy balanced, then accuracy-maximized | Experimental | All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. Receives: Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition |
| Accuracy-maximized, then effort-maximized, then effort-accuracy balanced | Experimental | All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. Receives: Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition |
| Accuracy-maximized, then effort-accuracy balanced, then effort-maximized | Experimental | All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. Receives: Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition |
| Effort-accuracy balanced, then effort-maximized, then accuracy maximized | Experimental | All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. Receives: Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition |
| Effort-accuracy balanced, then accuracy-maximized, then effort-maximized | Experimental | All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. Receives: Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in correct responses in Confrontation Naming of Treated Pictured Objects
Confrontation naming accuracy of pictures targeted in each training condition will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated items will serve as the primary outcome measure.
Measured: Initial assessment (pre-treatment), 3 months post-treatment
Secondary outcomes (5)
Change in correct responses in Confrontation Naming of Untreated Pictured Objects
Confrontation naming accuracy of pictured untreated items (matched for linguistic difficulty to treated items in the primary outcome) for each training condition will serve as a secondary outcome control condition.
Measured: Initial assessment (pre-treatment), 3 months post-treatment
Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
Production of trained words on the context generalization complex scene description task for each training condition and corresponding untreated items will serve as a secondary outcome. Words from complex scenes and wordless picture books will be chosen for each participant. These words will consist of a subset of those selected for confrontation naming. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as a secondary outcome measure.
Measured: Initial assessment (pre-treatment), 3 months post-treatment
Change in core lexicon analysis on the Aphasia Bank Discourse Protocol
The Aphasia Bank Discourse Protocol is a brief, but thorough set of language tasks which will characterize participants' language at the discourse level. The protocol requires participants to generate discourse samples within the contexts of free speech, a picture description, a story narrative, and procedural discourse. Change in performance in core lexicon analysis on discourse samples from initial assessment to each post-treatment follow up timepoint will serve as a secondary outcome measure.
Measured: Initial assessment (pre-treatment), 3-months post-treatment
Change in mean scores on the Aphasia Communication Outcome Measure Short-Form
The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported "communication functioning," defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.
Measured: Initial assessment (pre-treatment), 1 week post-treatment.
Score on the Adapted Intrinsic Motivation Inventory for Aphasia
The adapted intrinsic motivation Inventory for aphasia is a brief instrument comprised of 7 subscales with a total of 45 items intended to characterize intrinsic motivation in people with aphasia. Each item is scored on a scale of 1-7. Higher total score is associated with higher intrinsic motivation.
Measured: 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start27 Nov 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Amherst, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, William Evans, University of Pittsburgh
- Investigators
- William Evans, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653440
- Sponsor's protocol ID
- STUDY21120130 (Study 1)
- Other IDs
- 1R01DC019325-01A1
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing plan for this study includes the publication of discourse measures and other study data on Aphasia Bank (R01-DC008524), a large online repository of aphasia behavioral data that supports a great deal of productive aphasia corpora research. De-identified test scores, treatment, and probe data, and audio and/or video recordings of norming, probe, assessment, and treatment data will be shared to this repository for all study participants. Investigators will also make our experimental task files, protocols, and de-identified study data available through Open Science Framework (https://osf.io/) to encourage the replication, collaboration, and expansion of our work by other research groups. Last, investigators plan to publish a modeling and statistical package in open-access software, R, which will include functionality for calculating speed-accuracy tradeoff optimality using our multinomial ex-Gaussian response time model approach.
Publications
van der Stelt CM, Cavanaugh R, Hula WD, Starns J, Kelly A, Goodman ML, Terhorst L, Hassany M, Brusilovsky P, Evans WS. Adaptive balancing of effort, accuracy and response speed in anomia treatment for post-stroke aphasia in community-based settings in the USA: a within-subjects randomised controlled trial protocol. BMJ Open. 2026 May 20;16(5):e116172. doi: 10.1136/bmjopen-2025-116172.
PubMed 42161555
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 1: Balancing Effortful and Errorless Learning Via Adaptive Naming Deadlines)
- ClinicalTrials.gov ID
- NCT05653440
- Acronym / sponsor ID
- STUDY21120130 (Study 1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Massachusetts, Amherst, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 16 Dec 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.
Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life.
This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines.
Detailed description
Study 1: Evaluate the benefits of balancing effortful and errorless learning via adaptive naming deadlines.
- Study design: The investigators will enroll 30 people with aphasia in a randomized within-subjects crossover design comparing trained words in three retrieval conditions. Stimuli will be balanced across conditions using an established item-response theory algorithm developed by Dr. Hula (consultant). Participants will receive 8 sessions of treatment per condition (2x/ week for 4 weeks), with probes administered at baseline and 1 week, 3 months, and 6 months post-treatment. Condition treatment order will be randomly assigned and counter- balanced across participants. In total, Sub-study 1 includes typically 3-4 (but up to 6) assessment sessions, 24 treatment sessions, and 24 baseline and follow-up probe assessment sessions per participant over an approximately 10-month period, but up to 18 months. Data collection will take place at the Language Rehabilitation and Cognition Laboratory (LRCL) at the University of Pittsburgh, in participants' homes, or in private rooms in public spaces (e.g. libraries, community centers).
- Participants: The investigators will recruit 30 male and female community-dwelling people with aphasia >6 months post- onset of aphasia due to left-hemisphere ischemic or hemorrhagic stroke. Aphasia diagnosis will be confirmed by Comprehensive Aphasia Test (CAT) performance and medical history. Investigators will exclude potential participants with a history of other acquired or progressive neurological disease, significant language comprehension impairments, unmanaged drug/alcohol dependence, and severe diagnosed mood or behavioral disorders that require specialized mental health interventions.
- Assessment Procedures: Participants will be tested on a comprehensive initial battery of standardized assessments characterizing their aphasia severity and overall language profile, naming and discourse abilities, semantic processing, verbal short-term and working memory at baseline. Patient-reported measures of treatment motivation and pre-post changes in communication effectiveness will also be measured in response to each treatment condition. These tests will ensure that our participants well-characterized from a behavioral perspective, and measures will be used in secondary analyses and model development exploring predictors of treatment response.
- Treatment description: Each training trial will consist of a fixation cross and picture presentation. A repetition cue (audio recording and written from of the target) will be provided to participants based on the deadlines described above. Participants will be instructed to name the picture and indicate when they have given their final answer via key press, with responses also timed and scored by clinician key press. In the errorless condition, they will be instructed to repeat the target, while in the other conditions they will be asked to try to name the picture independently before they hear the target. Once they have indicated that they have provided their final answer, they will receive accuracy feedback on the computer screen based on clinician scoring. To maximize the clinical relevance of this study, investigators will control total amount of treatment time (8 hours) between conditions, instead of controlling the total number of trials. This is because many more trials can be completed per hour in the errorless or balanced conditions compared to the effort-maximized condition, and investigators want study outcomes to practically inform clinicians on how best to spend limited treatment time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Effort-maximized, then accuracy-maximized, then effort-accuracy balanced | Experimental | Behavioral: Accuracy-maximized condition, Behavioral: Effort-maximized condition, Behavioral: Effort-accuracy balanced conditionAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. |
| Effort-maximized, then effort-accuracy balanced, then accuracy-maximized | Experimental | Behavioral: Accuracy-maximized condition, Behavioral: Effort-maximized condition, Behavioral: Effort-accuracy balanced conditionAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. |
| Accuracy-maximized, then effort-maximized, then effort-accuracy balanced | Experimental | Behavioral: Accuracy-maximized condition, Behavioral: Effort-maximized condition, Behavioral: Effort-accuracy balanced conditionAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. |
| Accuracy-maximized, then effort-accuracy balanced, then effort-maximized | Experimental | Behavioral: Accuracy-maximized condition, Behavioral: Effort-maximized condition, Behavioral: Effort-accuracy balanced conditionAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. |
| Effort-accuracy balanced, then effort-maximized, then accuracy maximized | Experimental | Behavioral: Accuracy-maximized condition, Behavioral: Effort-maximized condition, Behavioral: Effort-accuracy balanced conditionAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. |
| Effort-accuracy balanced, then accuracy-maximized, then effort-maximized | Experimental | Behavioral: Accuracy-maximized condition, Behavioral: Effort-maximized condition, Behavioral: Effort-accuracy balanced conditionAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Existing diagnosis of chronic (>6 months) aphasia subsequent to left hemisphere ischemic or hemorrhagic stroke.
- Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.
Key exclusion criteria (4 listed)
- History of other acquired or progressive neurological disease.
- Significant language comprehension impairments
- Unmanaged drug / alcohol dependence.
- Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.
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 |
|---|---|---|
| Accuracy-maximized conditionNaming treatment condition in which the target will be immediately provided for repetition at picture onset. | Behavioural | Accuracy-maximized, then effort-accuracy balanced, then effort-maximized, Accuracy-maximized, then effort-maximized, then effort-accuracy balanced, Effort-accuracy balanced, then accuracy-maximized, then effort-maximized, Effort-accuracy balanced, then effort-maximized, then accuracy maximized, Effort-maximized, then accuracy-maximized, then effort-accuracy balanced, Effort-maximized, then effort-accuracy balanced, then accuracy-maximized |
| Effort-maximized conditionNaming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition. | Behavioural | Accuracy-maximized, then effort-accuracy balanced, then effort-maximized, Accuracy-maximized, then effort-maximized, then effort-accuracy balanced, Effort-accuracy balanced, then accuracy-maximized, then effort-maximized, Effort-accuracy balanced, then effort-maximized, then accuracy maximized, Effort-maximized, then accuracy-maximized, then effort-accuracy balanced, Effort-maximized, then effort-accuracy balanced, then accuracy-maximized |
| Effort-accuracy balanced conditionNaming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time. | Behavioural | Accuracy-maximized, then effort-accuracy balanced, then effort-maximized, Accuracy-maximized, then effort-maximized, then effort-accuracy balanced, Effort-accuracy balanced, then accuracy-maximized, then effort-maximized, Effort-accuracy balanced, then effort-maximized, then accuracy maximized, Effort-maximized, then accuracy-maximized, then effort-accuracy balanced, Effort-maximized, then effort-accuracy balanced, then accuracy-maximized |
Primary outcome
Change in correct responses in Confrontation Naming of Treated Pictured Objects
Time frame: Initial assessment (pre-treatment), 3 months post-treatment
Confrontation naming accuracy of pictures targeted in each training condition will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated items will serve as the primary outcome measure.
5 secondary outcomes
Change in correct responses in Confrontation Naming of Untreated Pictured Objects
Time frame: Initial assessment (pre-treatment), 3 months post-treatment
Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
Time frame: Initial assessment (pre-treatment), 3 months post-treatment
Change in core lexicon analysis on the Aphasia Bank Discourse Protocol
Time frame: Initial assessment (pre-treatment), 3-months post-treatment
Change in mean scores on the Aphasia Communication Outcome Measure Short-Form
Time frame: Initial assessment (pre-treatment), 1 week post-treatment.
Score on the Adapted Intrinsic Motivation Inventory for Aphasia
Time frame: 1 week 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 13 Apr 2026.
- Derived from this study: PubMed 42161555van der Stelt CM, Cavanaugh R, Hula WD, Starns J, Kelly A, Goodman ML, Terhorst L, Hassany M, Brusilovsky P, Evans WS. Adaptive balancing of effort, accuracy and response speed in anomia treatment for post-stroke aphasia in community-based settings in the USA: a within-subjects randomised controlled trial protocol. BMJ Open. 2026 May 20;16(5):e116172. doi: 10.1136/bmjopen-2025-116172.
- Individual participant dataSharing planned: Yes. The data sharing plan for this study includes the publication of discourse measures and other study data on Aphasia Bank (R01-DC008524), a large online repository of aphasia behavioral data that supports a great deal of productive aphasia corpora research. De-identified test scores, treatment, and probe data, and audio and/or video recordings of norming, probe, assessment, and treatment data will be shared to this repository for all study participants. Investigators will also make our experimental task files, protocols, and de-identified study data available through Open Science Framework (https://osf.io/) to encourage the replication, collaboration, and expansion of our work by other research groups. Last, investigators plan to publish a modeling and statistical package in open-access software, R, which will include functionality for calculating speed-accuracy tradeoff optimality using our multinomial ex-Gaussian response time model approach.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
William Evans, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Accuracy-maximized condition, Effort-maximized condition and Effort-accuracy balanced condition in people with Aphasia and Stroke, run by University of Pittsburgh 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 2 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 13 Apr 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alyssa Kelly, M.A., CCC-SLP (412-648-3274, ank155@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in correct responses in Confrontation Naming of Treated Pictured Objects (time frame: Initial assessment (pre-treatment), 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05653440, which also lists 1 linked publication.
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 13 Apr 2026.