AphasiaNCT06364709
Criterion-learning Based Naming Treatment in Aphasia
A study testing Criterion-learning practice in people with Aphasia, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Aphasia is a disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Criterion-learning practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English as a native or primary language
- Adults with stroke who are at least 6 months post-onset
Who cannot join
- History of comorbid neurological diagnoses, such as Multiple Sclerosis or Parkinson's Disease
- History of a learning disability that significantly impacted language development, such as developmental language disorder
- Insufficient stamina to participate in the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
About this study
Official title: Word Retrieval in Aphasia
Aphasia is a disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. The overarching goal of this project is to develop and test early efficacy, efficiency, and the tolerability of a lexical treatment for aphasia in multiple-session regimens that are comprised of retrieval practice, distributed practice, and training dedicated to the elicitation of correct retrievals. The aim of this work is to add to and refine the evidence base for the implementation and optimization of these elements in the treatment of production and comprehension deficits in aphasia, and make important steps towards an ultimate goal of self-administered lexical treatment grounded in retrieval practice principles (RPP) to supplement traditional speech-language therapy that is appropriate for People with Aphasia (PWA) from a broad level of severity of lexical processing deficit in naming and/or comprehension. This project cumulatively builds on prior work to develop a theory of learning for lexical processing impairment in aphasia that aims to ultimately explain why and for whom familiar lexical treatments work, and how to maximize the benefits they confer.
Read the detailed description
This study examines a retrieval practice-based naming treatment termed criterion learning. In criterion learning, each item's assigned criterion level dictates the number of times that item is correctly retrieved before it is dropped from further training within a session. Criterion learning optimally incorporates potent learning experiences, including spaced retrieval practice with emphasis on correct retrievals during training. By examining scheduling and dosing parameters the present study will provide critical observations for optimizing criterion learning for treating word processing deficits in people with aphasia. This study will recruit 20 community-dwelling individuals with aphasia, who will undergo comprehensive neuropsychological characterization. Subsequently, participants will engage in an experimental treatment designed to promote improvements in word retrieval deficits.
This study will examine naming mastery of personally-relevant, functional vocabulary for PWA as a function of per-item naming practice dosage (i.e., criterion-level) and number of training sessions. Each participant will take part in a multi-session naming treatment study requiring completion of five training sessions generally separated by one-week. A retention test of naming performance will be administered approximately one week following the final training session. The first trial per item in sessions following the initial session serves as a one-week test of retention of prior training. Analyses will identify the item-dosage and session-dosage that most efficiently confers the highest naming mastery of treated items at a one-week retention interval.
- Conditions
- Aphasia
- Being tested
- Criterion-learning practice
- Keywords
- anomia, retrieval practice, word-finding problem, communication disorder, naming impairment, word comprehension impairment
- Medical subject headings
- Aphasia, Anomia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Criterion-learning practiceBehavioural
The experiments will be presented on a computer. On each criterion-learning trial, a picture is presented and the participant is asked to try to produce the name for the object with or without a cue. Correct-answer feedback is provided. Criterion learning involves presenting a block of items in fixed order, and on each trial, the experimenter or a voice-recognition component will code the response during the trial as correct/incorrect. When the item reaches its assigned criterion level, it is dropped from further training in a session.
| Study group | Role | What they receive |
|---|---|---|
| Criterion-learning practice | Experimental | This is a single-arm study. Receives: Behavioral: Criterion-learning practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trained naming items
Confrontation naming task that involves trained items
Measured: during treatment
Secondary outcomes (1)
Trained naming items
Confrontation naming task that involves trained items
Measured: pre-treatment, approximately one-week following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Oct 2024
- Primary completion28 Apr 2026
- Study completion4 May 2026
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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Erica Middleton, Albert Einstein Healthcare Network
- Investigators
- Erica L Middleton, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364709
- Sponsor's protocol ID
- 4526.1
- Other IDs
- R01DC015516
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Word Retrieval in Aphasia
- ClinicalTrials.gov ID
- NCT06364709
- Acronym / sponsor ID
- 4526.1
- Conditions
- Aphasia
- Keywords
- anomia, retrieval practice, word-finding problem, communication disorder, naming impairment, word comprehension impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 15 Apr 2024 (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 disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. The overarching goal of this project is to develop and test early efficacy, efficiency, and the tolerability of a lexical treatment for aphasia in multiple-session regimens that are comprised of retrieval practice, distributed practice, and training dedicated to the elicitation of correct retrievals. The aim of this work is to add to and refine the evidence base for the implementation and optimization of these elements in the treatment of production and comprehension deficits in aphasia, and make important steps towards an ultimate goal of self-administered lexical treatment grounded in retrieval practice principles (RPP) to supplement traditional speech-language therapy that is appropriate for People with Aphasia (PWA) from a broad level of severity of lexical processing deficit in naming and/or comprehension. This project cumulatively builds on prior work to develop a theory of learning for lexical processing impairment in aphasia that aims to ultimately explain why and for whom familiar lexical treatments work, and how to maximize the benefits they confer.
Detailed description
This study examines a retrieval practice-based naming treatment termed criterion learning. In criterion learning, each item's assigned criterion level dictates the number of times that item is correctly retrieved before it is dropped from further training within a session. Criterion learning optimally incorporates potent learning experiences, including spaced retrieval practice with emphasis on correct retrievals during training. By examining scheduling and dosing parameters the present study will provide critical observations for optimizing criterion learning for treating word processing deficits in people with aphasia. This study will recruit 20 community-dwelling individuals with aphasia, who will undergo comprehensive neuropsychological characterization. Subsequently, participants will engage in an experimental treatment designed to promote improvements in word retrieval deficits.
This study will examine naming mastery of personally-relevant, functional vocabulary for PWA as a function of per-item naming practice dosage (i.e., criterion-level) and number of training sessions. Each participant will take part in a multi-session naming treatment study requiring completion of five training sessions generally separated by one-week. A retention test of naming performance will be administered approximately one week following the final training session. The first trial per item in sessions following the initial session serves as a one-week test of retention of prior training. Analyses will identify the item-dosage and session-dosage that most efficiently confers the highest naming mastery of treated items at a one-week retention interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Criterion-learning practice | Experimental | Behavioral: Criterion-learning practiceThis is a single-arm study. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English as a native or primary language
- Adults with stroke who are at least 6 months post-onset
Key exclusion criteria (3 listed)
- History of comorbid neurological diagnoses, such as Multiple Sclerosis or Parkinson's Disease
- History of a learning disability that significantly impacted language development, such as developmental language disorder
- Insufficient stamina to participate in the protocol
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 |
|---|---|---|
| Criterion-learning practiceThe experiments will be presented on a computer. On each criterion-learning trial, a picture is presented and the participant is asked to try to produce the name for the object with or without a cue. Correct-answer feedback is provided. Criterion learning involves presenting a block of items in fixed order, and on each trial, the experimenter or a voice-recognition component will code the response during the trial as correct/incorrect. When the item reaches its assigned criterion level, it is dropped from further training in a session. | Behavioural | Criterion-learning practice |
Primary outcome
Trained naming items
Time frame: during treatment
Confrontation naming task that involves trained items
1 secondary outcome
Trained naming items
Time frame: pre-treatment, approximately one-week following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).
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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. This study is not recruiting at the moment.
Erica L Middleton, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Criterion-learning practice in people with Aphasia, run by Albert Einstein Healthcare Network 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 3 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: finished, as of the sponsor's last update on 8 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trained naming items (time frame: during treatment). 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 8 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.