Criterion-learning Based Naming Treatment in Aphasia

NCT ID: NCT06364709

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2028-08-31

Brief 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. 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.

Conditions

Aphasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Criterion-learning practice

This is a single-arm study.

Group Type: EXPERIMENTAL

Criterion-learning practice

Intervention Type: BEHAVIORAL

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.

Interventions

Criterion-learning practice

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English as a native or primary language
• Adults with stroke who are at least 6 months post-onset

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Erica Middleton

Institute Scientist, Jefferson Moss Rehabilitation Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erica L Middleton, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

Jefferson Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DC015516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4526.1

Identifier Type: -

Identifier Source: org_study_id