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Criterion-learning Based Naming Treatment in Aphasia

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ClinicalTrials.gov Identifier: NCT06364709
Recruitment Status : Not yet recruiting
First Posted : April 15, 2024
Last Update Posted : April 15, 2024
Sponsor:
Collaborators:
Thomas Jefferson University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Erica Middleton, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Criterion-learning practice Not Applicable

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, and feasibility of at-home delivery, the present study will provide critical observations for optimizing criterion learning for treating word processing deficits in people with aphasia. This study will recruit 90 community-dwelling individuals with aphasia, who will undergo comprehensive neuropsychological characterization which may include neuroimaging. Subsequently, participants will engage in treatments designed to promote improvements in word retrieval deficits. To advance theoretical and clinical aims, depending on outcomes of neuropsychological characterization, participants may be invited to complete one or more experiments.

Experiment 1 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.

Experiment 2 will adopt the most efficient item-dosage/session-dosage schedule identified in Study Arm 1. In Study Arm 2, each PWA will complete an in-lab module, and an at-home module, with each module preceded by a baseline phase and followed by naming post-tests. Different sets of personally-relevant, functional items will be assigned to the two modules for each PWA. A retention test will be administered in the lab after the final training session in each module, and each test will include a set of untreated items, to probe a potential generalized benefit of the treatment. To assess individual benefits, improvement on the retention test will be calculated relative to baseline in each module.

Experiment 3 will examine whether making retrieval practice more effortful by increasing semantically-driven lexical competition enhances naming treatment efficacy in a multiple-session naming treatment. This involves training items amidst related (e.g., for "dog," horse, cow, zebra) or unrelated items (e.g., for "dog," ambulance, pencil, rose). Each PWA will complete multiple training/test rounds--a round refers to the two training sessions separated by approximately 1-week, and a retention test for those items.

Experiment 4 will examine transfer from two types of naming treatment to word comprehension performance. Each PWA will perform naming treatment in one session at different dosages with a retention test of comprehension performance administered approximately one week and one month following treatment. Main outcomes of interest will be degree of transfer of each type of naming treatment to comprehension performance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Word Retrieval in Aphasia
Estimated Study Start Date : May 15, 2024
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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.




Primary Outcome Measures :
  1. Trained naming items (Experiment 1) [ Time Frame: during treatment ]
    Confrontation naming task that involves trained items

  2. Trained naming items (Experiment 2) [ Time Frame: pre-treatment, approximately one-week and one-month following treatment ]
    Confrontation naming task that involves trained items

  3. Trained naming items (Experiment 3) [ Time Frame: approximately one-week following treatment ]
    Confrontation naming task that involves trained items

  4. Trained comprehension items (Experiment 4) [ Time Frame: approximately one-week and one-month following treatment ]
    Word-picture verification task


Secondary Outcome Measures :
  1. Trained naming items (Experiment 1) [ Time Frame: pre-treatment, approximately one-week following treatment ]
    Confrontation naming task that involves trained items

  2. Trained naming items (Experiment 2) [ Time Frame: during treatment ]
    Confrontation naming task that involves trained items

  3. Untrained naming items (Experiment 2) [ Time Frame: pre-treatment, approximately one-week and one-month post-treatment ]
    Confrontation naming task that involves untrained items

  4. Trained naming items (Experiment 3) [ Time Frame: pre-treatment, during treatment ]
    Confrontation naming task that involves trained items

  5. Trained naming items (Experiment 4) [ Time Frame: during treatment ]
    Confrontation naming task that involves trained items

  6. Trained comprehension items (Experiment 4) [ Time Frame: pre-treatment ]
    Word-picture verification task

  7. Untrained comprehension items (Experiment 4) [ Time Frame: pre-treatment, approximately one-week and one-month post-treatment ]
    Word-picture verification task

  8. Treatment compliance (Experiment 2) [ Time Frame: during treatment ]
    Completion of treatment blocks and sessions


Other Outcome Measures:
  1. Connected speech output performance [ Time Frame: pre-treatment, approximately one-week post-treatment ]
    Probes of pictures description using connected speech



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06364709


Contacts
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Contact: Kelly Horel, CCC SLP 215-663-6017 kelly.horel@jefferson.edu

Sponsors and Collaborators
Albert Einstein Healthcare Network
Thomas Jefferson University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Erica L Middleton, PhD Albert Einstein Healthcare Network
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Responsible Party: Erica Middleton, Institute Scientist, Moss Rehabilitation Research Institute, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT06364709    
Other Study ID Numbers: 4526
R01DC015516 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2024    Key Record Dates
Last Update Posted: April 15, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).
Supporting Materials: Analytic Code
Time Frame: 6 months following publication
Access Criteria: Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erica Middleton, Albert Einstein Healthcare Network:
anomia
retrieval practice
word-finding problem
communication disorder
naming impairment
word comprehension impairment
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases