A Phase 2 interventional study of Accuracy-maximized condition and Effort-maximized condition in Aphasia and Stroke, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
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.
Study 1: Evaluate the benefits of balancing effortful and errorless learning via adaptive naming deadlines.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Accuracy-maximized condition · Behavioral: Effort-maximized condition · Behavioral: Effort-accuracy balanced condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Accuracy-maximized condition · Behavioral: Effort-maximized condition · Behavioral: Effort-accuracy balanced condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Accuracy-maximized condition · Behavioral: Effort-maximized condition · Behavioral: Effort-accuracy balanced condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Accuracy-maximized condition · Behavioral: Effort-maximized condition · Behavioral: Effort-accuracy balanced condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Accuracy-maximized condition · Behavioral: Effort-maximized condition · Behavioral: Effort-accuracy balanced condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Accuracy-maximized condition · Behavioral: Effort-maximized condition · Behavioral: Effort-accuracy balanced condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
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.
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.
Time frame: Initial assessment (pre-treatment), 3 months post-treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week post-treatment
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be shared at the time of study publication without planned end to access.
Access criteria: Anyone who wishes to access the data.
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