NCT07179458

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jun 2024Aug 2028

Study Start

First participant enrolled

June 24, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

August 25, 2025

Last Update Submit

October 2, 2025

Conditions

Keywords

anomiaretrieval practiceword-finding problemcommunication disordernaming impairmentword comprehension impairment

Outcome Measures

Primary Outcomes (1)

  • Trained comprehension items

    Word-picture verification task

    approximately one-week and one-month following treatment

Secondary Outcomes (3)

  • Trained naming items

    a single session held during a single day, scheduled at the participant's convenience but typically held within two weeks following pre-treatment assessment

  • Trained comprehension items

    pre-treatment

  • Untrained comprehension items

    pre-treatment, approximately one-week and one-month post-treatment

Study Arms (1)

Criterion-learning practice

EXPERIMENTAL

This is a single-arm study

Behavioral: Criterion-learning practice

Interventions

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.

Criterion-learning practice

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English as a native or primary language
  • Adults with stroke who are at least 6 months post-onset
  • Exhibit semantic comprehension deficit, defined as a minimum of 80 errors on word-picture verification pre-test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

MeSH Terms

Conditions

AphasiaAnomiaCommunication Disorders

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Erica L Middleton, PhD

    Albert Einstein Healthcare Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute Scientist, Jefferson Moss Rehabilitation Research Institute

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 17, 2025

Study Start

June 24, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).

Shared Documents
ANALYTIC CODE
Time Frame
6 months following publication
Access Criteria
Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).

Locations