Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT07179458
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-07
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Criterion-learning Naming Treatment For Addressing Comprehension Deficits in Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D000849', 'term': 'Anomia'}, {'id': 'D003147', 'term': 'Communication Disorders'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-14', 'size': 554464, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-02T08:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trained comprehension items', 'timeFrame': 'approximately one-week and one-month following treatment', 'description': 'Word-picture verification task'}], 'secondaryOutcomes': [{'measure': 'Trained naming items', 'timeFrame': "a single session held during a single day, scheduled at the participant's convenience but typically held within two weeks following pre-treatment assessment", 'description': 'Confrontation naming task that involves trained items'}, {'measure': 'Trained comprehension items', 'timeFrame': 'pre-treatment', 'description': 'Word-picture verification task'}, {'measure': 'Untrained comprehension items', 'timeFrame': 'pre-treatment, approximately one-week and one-month post-treatment', 'description': 'Word-picture verification task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anomia', 'retrieval practice', 'word-finding problem', 'communication disorder', 'naming impairment', 'word comprehension impairment'], 'conditions': ['Aphasia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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. 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 processing deficits.\n\nThis study 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 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English as a native or primary language\n* Adults with stroke who are at least 6 months post-onset\n* Exhibit semantic comprehension deficit, defined as a minimum of 80 errors on word-picture verification pre-test\n\nExclusion Criteria:\n\n* History of comorbid neurological diagnoses, such as Multiple Sclerosis or Parkinson's Disease\n* History of a learning disability that significantly impacted language development, such as developmental language disorder\n* Insufficient stamina to participate in the protocol"}, 'identificationModule': {'nctId': 'NCT07179458', 'briefTitle': 'Criterion-learning Naming Treatment For Addressing Comprehension Deficits in Aphasia', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein Healthcare Network'}, 'officialTitle': 'Word Retrieval in Aphasia', 'orgStudyIdInfo': {'id': '4526.4'}, 'secondaryIdInfos': [{'id': 'R01DC015516', 'link': 'https://reporter.nih.gov/quickSearch/R01DC015516', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Criterion-learning practice', 'description': 'This is a single-arm study', 'interventionNames': ['Behavioral: Criterion-learning practice']}], 'interventions': [{'name': 'Criterion-learning practice', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Criterion-learning practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19027', 'city': 'Elkins Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Moss Rehabilitation Research Institute', 'geoPoint': {'lat': 40.07706, 'lon': -75.12684}}], 'overallOfficials': [{'name': 'Erica L Middleton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein Healthcare Network'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': '6 months following publication', 'ipdSharing': 'YES', 'description': 'Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).', 'accessCriteria': 'Anonymized data and analysis code will be accessible on the Open Science Framework (OSF).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein Healthcare Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thomas Jefferson University', 'class': 'OTHER'}, {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute Scientist, Jefferson Moss Rehabilitation Research Institute', 'investigatorFullName': 'Erica Middleton', 'investigatorAffiliation': 'Albert Einstein Healthcare Network'}}}}