Criterion-learning Based Naming Treatment in Aphasia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Criterion-learning practice

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Jefferson Moss Rehabilitation Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Criterion-learning practice; This is a single-arm study.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trained naming items	Confrontation naming task that involves trained items	during treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trained naming items	Confrontation naming task that involves trained items	pre-treatment, approximately one-week following treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connected speech output performance	Probes of pictures description using connected speech	pre-treatment, approximately one-week post-treatment

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Collaborators: Thomas Jefferson University; National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Erica L Middleton, PhD, Albert Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: anomia; communication disorder; retrieval practice; word-finding problem; naming impairment; word comprehension impairment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Aphasia; Communication Disorders; Anomia
• Other Study ID Numbers: 4526.1; R01DC015516 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).
• IPD Sharing Time Frame: 6 months following publication
• IPD Sharing Access Criteria: Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No