Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia

NCT05653440 | Recruiting Phase 2

• 2 other identifiers: STUDY21120130 (Study 1)1R01DC019325-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 1, which will adaptively balance effort and accuracy using speeded naming deadlines.

Conditions

Aphasia; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in correct responses in Confrontation Naming of Treated Pictured Objects

  Confrontation naming accuracy of pictures targeted in each training condition 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 items will serve as the primary outcome measure.

  Initial assessment (pre-treatment), 3 months post-treatment

Secondary Outcomes (5)

• Change in correct responses in Confrontation Naming of Untreated Pictured Objects

  Initial assessment (pre-treatment), 3 months post-treatment

• Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects

  Initial assessment (pre-treatment), 3 months post-treatment

• Change in core lexicon analysis on the Aphasia Bank Discourse Protocol

  Initial assessment (pre-treatment), 3-months post-treatment

• Change in mean scores on the Aphasia Communication Outcome Measure Short-Form

  Initial assessment (pre-treatment), 1 week post-treatment.

• Score on the Adapted Intrinsic Motivation Inventory for Aphasia

  1 week post-treatment

Study Arms (6)

Effort-maximized, then accuracy-maximized, then effort-accuracy balanced

EXPERIMENTAL

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition

Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

EXPERIMENTAL

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition

Accuracy-maximized, then effort-maximized, then effort-accuracy balanced

EXPERIMENTAL

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized

EXPERIMENTAL

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition

Effort-accuracy balanced, then effort-maximized, then accuracy maximized

EXPERIMENTAL

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition

Effort-accuracy balanced, then accuracy-maximized, then effort-maximized

EXPERIMENTAL

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Accuracy-maximized condition; Behavioral: Effort-maximized condition; Behavioral: Effort-accuracy balanced condition

Interventions

Accuracy-maximized condition BEHAVIORAL

Naming treatment condition in which the target will be immediately provided for repetition at picture onset.

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized; Accuracy-maximized, then effort-maximized, then effort-accuracy balanced; Effort-accuracy balanced, then accuracy-maximized, then effort-maximized; Effort-accuracy balanced, then effort-maximized, then accuracy maximized; Effort-maximized, then accuracy-maximized, then effort-accuracy balanced; Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

Effort-maximized condition BEHAVIORAL

Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized; Accuracy-maximized, then effort-maximized, then effort-accuracy balanced; Effort-accuracy balanced, then accuracy-maximized, then effort-maximized; Effort-accuracy balanced, then effort-maximized, then accuracy maximized; Effort-maximized, then accuracy-maximized, then effort-accuracy balanced; Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

Effort-accuracy balanced condition BEHAVIORAL

Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized; Accuracy-maximized, then effort-maximized, then effort-accuracy balanced; Effort-accuracy balanced, then accuracy-maximized, then effort-maximized; Effort-accuracy balanced, then effort-maximized, then accuracy maximized; Effort-maximized, then accuracy-maximized, then effort-accuracy balanced; Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing diagnosis of chronic (\>6 months) aphasia subsequent to left hemisphere ischemic or hemorrhagic stroke.
• Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.

You may not qualify if:

• History of other acquired or progressive neurological disease.
• Significant language comprehension impairments
• Unmanaged drug / alcohol dependence.
• Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Massachusetts, Amherst: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• William Evans, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Kelly, M.A., CCC-SLP

CONTACT

412-648-3274; ank155@pitt.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants responsible for coding data will be masked to treatment condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: November 27, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)