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Recruiting NCT05653440

Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia

Phase II Interventional Aphasia Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Accuracy-maximized condition, Effort-maximized condition, Effort-accuracy balanced condition.
Who it may be relevant to
Registry conditions: Aphasia, Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 1: Balancing Effortful and Errorless Learning Via Adaptive Naming Deadlines)

Overview

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.

Detailed description

Study 1: Evaluate the benefits of balancing effortful and errorless learning via adaptive naming deadlines.

* Study design: The investigators will enroll 30 people with aphasia in a randomized within-subjects crossover design comparing trained words in three retrieval conditions. Stimuli will be balanced across conditions using an established item-response theory algorithm developed by Dr. Hula (consultant). Participants will receive 8 sessions of treatment per condition (2x/ week for 4 weeks), with probes administered at baseline and 1 week, 3 months, and 6 months post-treatment. Condition treatment order will be randomly assigned and counter- balanced across participants. In total, Sub-study 1 includes typically 3-4 (but up to 6) assessment sessions, 24 treatment sessions, and 24 baseline and follow-up probe assessment sessions per participant over an approximately 10-month period, but up to 18 months. Data collection will take place at the Language Rehabilitation and Cognition Laboratory (LRCL) at the University of Pittsburgh, in participants' homes, or in private rooms in public spaces (e.g. libraries, community centers). * Participants: The investigators will recruit 30 male and female community-dwelling people with aphasia \>6 months post- onset of aphasia due to left-hemisphere ischemic or hemorrhagic stroke. Aphasia diagnosis will be confirmed by Comprehensive Aphasia Test (CAT) performance and medical history. Investigators will exclude potential participants with a history of other acquired or progressive neurological disease, significant language comprehension impairments, unmanaged drug/alcohol dependence, and severe diagnosed mood or behavioral disorders that require specialized mental health interventions. * Assessment Procedures: Participants will be tested on a comprehensive initial battery of standardized assessments characterizing their aphasia severity and overall language profile, naming and discourse abilities, semantic processing, verbal short-term and working memory at baseline. Patient-reported measures of treatment motivation and pre-post changes in communication effectiveness will also be measured in response to each treatment condition. These tests will ensure that our participants well-characterized from a behavioral perspective, and measures will be used in secondary analyses and model development exploring predictors of treatment response. * Treatment description: Each training trial will consist of a fixation cross and picture presentation. A repetition cue (audio recording and written from of the target) will be provided to participants based on the deadlines described above. Participants will be instructed to name the picture and indicate when they have given their final answer via key press, with responses also timed and scored by clinician key press. In the errorless condition, they will be instructed to repeat the target, while in the other conditions they will be asked to try to name the picture independently before they hear the target. Once they have indicated that they have provided their final answer, they will receive accuracy feedback on the computer screen based on clinician scoring. To maximize the clinical relevance of this study, investigators will control total amount of treatment time (8 hours) between conditions, instead of controlling the total number of trials. This is because many more trials can be completed per hour in the errorless or balanced conditions compared to the effort-maximized condition, and investigators want study outcomes to practically inform clinicians on how best to spend limited treatment time.

Interventions

  • Behavioral Accuracy-maximized condition
    Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
  • Behavioral Effort-maximized condition
    Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
  • Behavioral Effort-accuracy balanced condition
    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.

Primary outcome measures

  • Change in correct responses in Confrontation Naming of Treated Pictured Objects [Time frame: Initial assessment (pre-treatment), 3 months post-treatment]
Secondary outcome measures (5)
  • Change in correct responses in Confrontation Naming of Untreated Pictured Objects [Time frame: Initial assessment (pre-treatment), 3 months post-treatment]
  • Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects [Time frame: Initial assessment (pre-treatment), 3 months post-treatment]
  • Change in core lexicon analysis on the Aphasia Bank Discourse Protocol [Time frame: Initial assessment (pre-treatment), 3-months post-treatment]
  • Change in mean scores on the Aphasia Communication Outcome Measure Short-Form [Time frame: Initial assessment (pre-treatment), 1 week post-treatment.]
  • Score on the Adapted Intrinsic Motivation Inventory for Aphasia [Time frame: 1 week post-treatment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, Scho — Pittsburgh

Publications

  • van der Stelt CM, Cavanaugh R, Hula WD, Starns J, Kelly A, Goodman ML, Terhorst L, Hassany M, Brusilovsky P, Evans WS. Adaptive balancing of effort, accuracy and response speed in anomia treatment for post-stroke aphasia in community-based settings in the USA: a within-subjects randomised controlled trial protocol. BMJ Open. 2026 May 20;16(5):e116172. doi: 10.1136/bmjopen-2025-116172. PMID 42161555

Identifiers

NCT: NCT05653440 · STUDY21120130 (Study 1) · 1R01DC019325-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗