A Phase 2 interventional study of Adaptive Spacing Condition and High-Item Non-Adaptive Spacing 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 2025-12-11.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
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Among 175 studies in Aphasia with a site in United States — 50 open to participants now, 60 under way, 1 of them phase 3. Aphasia · United States.
Among the 175 studies in Aphasia with a site in United States, this one is the 75th largest by planned enrollment of the 158 interventional ones that give a count, is one of 16 that started in 2023, is one of 15 in phase 2, reaches primary completion later than 13 of the 59 other live ones, and was the 126th registered.
338 studies on the registry are indexed under Aphasia; 94 are open to participants now.
Browse Aphasia studies →50 of the 175 studies in Aphasia with a site in United States are open now. Recruiting first, the newest first:
Boston University Charles River Campus · Sites in United States
Ages 18–80
University of South Carolina · Sites in United States
Ages 25–80
University of South Carolina · Sites in United States
Ages 18+
Casa Colina Hospital and Centers for Healthcare · Sites in United States
Ages 18+
Maya Henry · Sites in United States
Ages 40+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 67 Aphasia studies recruiting now, 30 (45%) set no upper age limit and 11 (16%) stop at 75 or younger; 1 takes children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
175 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 19 · Phase 3 3 · Phase 4 1
First in 1992; this study’s year is marked. 16 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 32 is close to the median of 30 across 298 interventional studies indexed under Aphasia.
Median enrollment 30 across the 158 interventional studies, 62 across the 17 observational. Of the 102 that completed or were terminated, 46 (45%) have results posted.
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3 of 175 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 4 studies filed under Aphasia — fewer than ten, so there is no comparison to draw.
20 of the studies in Aphasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07036406Teachers College, Columbia UniversityComparing Traditional Semantic Feature Analysis (tSFA) and Semantic Feature Analysis + Metacognitive Strategy Training (SFA+MST) | 2026-12 |
| NCT06829420University of South FloridaMirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia | 2026-12-31 |
| NCT04142866City University of New YorkTranscranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia | 2026-12-31 |
| NCT04682223University of South CarolinaTelerehabilitation for Aphasia (TERRA) | 2027-01 |
| NCT07563387University of FloridataVNS for Speech and Language Recovery in Aphasia | 2027-01-01 |
Add all 20 to your calendar (.ics) → With an account.
Among the 175 studies in Aphasia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 2, which will evaluate the benefits of adaptive trial spacing.
Study 2: Evaluate the benefits of adaptive trial scheduling.
Study design: Investigators will enroll 32 people with aphasia in a randomized within-subjects crossover design comparing an adaptive scheduling condition to two non-adaptive conditions. For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. Participants will receive 10 weeks of computer-based training per condition, with probes administered at baseline and at 1 week, 3 months, and 6 months post-treatment. Condition order will be randomly assigned and counter-balanced across participants. In total, Study 2 will include typically 3-4 (but up to 6) assessment sessions, 120 one-on-one treatment sessions, and 24 baseline and follow-up probe sessions per participant over an \~1-year period, or up to 18 months. All assessment, treatment, and probe sessions will take place via telehealth.
Treatment description: For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. The treatment phase for each of the three conditions will consist of ten weeks of one-on-one treatment four times per week in which the treating clinician will work alongside participants to complete flashcard practice four days a week. The treatment sessions will each last 30 minutes to approximate realistic treatment dosage in outpatient or home health practice settings. Treatment will consist of effortful retrieval practice: on each trial, participants will see a picture of the target and attempt to name it, then rate their naming accuracy by button press. The experimenter will code their response time and perceived accuracy. Finally, the experimenter will code their accuracy which will reveal the target in verbal and written form. If they are unable to name the word correctly, they will be able to replay the answer and repeat it three times prior to moving on to the next trial, per Conroy et al.
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: Adaptive Spacing Condition · Behavioral: High-Item Non-Adaptive Spacing Condition · Behavioral: Low-Item Non-Adaptive Spacing Condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Adaptive Spacing Condition · Behavioral: High-Item Non-Adaptive Spacing Condition · Behavioral: Low-Item Non-Adaptive Spacing Condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Adaptive Spacing Condition · Behavioral: High-Item Non-Adaptive Spacing Condition · Behavioral: Low-Item Non-Adaptive Spacing Condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Adaptive Spacing Condition · Behavioral: High-Item Non-Adaptive Spacing Condition · Behavioral: Low-Item Non-Adaptive Spacing Condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Adaptive Spacing Condition · Behavioral: High-Item Non-Adaptive Spacing Condition · Behavioral: Low-Item Non-Adaptive Spacing Condition
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Behavioral: Adaptive Spacing Condition · Behavioral: High-Item Non-Adaptive Spacing Condition · Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.
Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
Confrontation naming accuracy pictures targeted for each training condition and corresponding untreated items 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 and untreated items will serve as the primary outcome measure.
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 primary 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 the primary 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.
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Jan 2027, 37 months after the start.
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