Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-04-07 @ 3:32 PM
Study NCT ID:
NCT06619756
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2024-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anomia Treatment Predictors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000849', 'term': 'Anomia'}, {'id': 'D001037', 'term': 'Aphasia'}], 'ancestors': [{'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication 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': 'D013064', 'term': 'Speech Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Naming of Trained Words', 'timeFrame': 'Pre-treatment and Immediately post-treatment', 'description': 'Picture naming of trained words'}], 'secondaryOutcomes': [{'measure': 'Naming of Untrained Words', 'timeFrame': 'Pre-treatment and Immediately post-treatment', 'description': 'Picture naming of untrained words'}, {'measure': 'Standardized Assessment of Phonology in Aphasia (SAPA)', 'timeFrame': 'Pre-treatment and Immediately post-treatment', 'description': 'The SAPA assesses phonological processing abilities, including oral reading, rhyme judgments, minimal pair judgments, lexical decision, blending, and parsing.'}, {'measure': 'Philadelphia Naming Test', 'timeFrame': 'Pre-treatment and Immediately post-treatment', 'description': 'The short-form of the Philadelphia Naming Test is a picture naming test of items not seen during treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anomia treatment', 'aphasia treatment'], 'conditions': ['Anomia (Word-Finding Impairment)', 'Aphasia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to identify predictors of response to phonological-focused anomia treatment in people with aphasia. The main question it aims to answer is who responds to which type of anomia treatment. Researchers will compare Phonomotor Treatment and Phonological Components Analysis to see which treatment is more beneficial, and for whom. Participants will engage in both treatments over several months.', 'detailedDescription': 'Participants will complete screening and characterization testing to determine eligibility for the study. Each treatment will be administered twice a week, for 10-15 sessions. Pre-treatment and post-treatment testing will also occur for each treatment. There will be a period of no treatment in between the first and second treatment blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic aphasia (6+ months)\n* Anomia\n* Sufficient auditory comprehension to follow task instructions\n* Phonologic impairment\n\nExclusion Criteria:\n\n* Progressive neurological illness or disease, including dementia\n* Chronic medical illness that interferes with adherence to testing schedule\n* Severe, uncorrected vision or hearing impairment that interferes with task completion\n* Moderate-severe apraxia of speech or dysarthria that interferes with task completion'}, 'identificationModule': {'nctId': 'NCT06619756', 'briefTitle': 'Anomia Treatment Predictors', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Predictors of Phonological-focused Anomia Treatment', 'orgStudyIdInfo': {'id': 'STUDY00008623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMT', 'description': 'Phonomotor Treatment (PMT) will be administered. This treatment improves anomia by training the sound sequences of words. This is a multimodal treatment approach that includes listening, producing, visualizing, and describing sounds and sound sequences. The participant practices the sound sequence tasks with the clinician.', 'interventionNames': ['Behavioral: Phonomotor Treatment (PMT)']}, {'type': 'EXPERIMENTAL', 'label': 'PCA', 'description': 'Phonological Components Analysis (PCA) will be administered. This treatment improves anomia by identifying phonological features of words. A picture is presented. The participant provides features of the picture name: the first sound of the word, the final sound of the word, the number of syllables of the word, another word that starts with the same sound, and another words that rhymes with the word. The participant attempts to produce the word independently and by repeating after the clinician.', 'interventionNames': ['Behavioral: Phonological Components Analysis (PCA)']}], 'interventions': [{'name': 'Phonomotor Treatment (PMT)', 'type': 'BEHAVIORAL', 'description': 'Anomia treatment focuses on improving word-finding abilities. This intervention targets the phonology of words to improve word-finding.', 'armGroupLabels': ['PMT']}, {'name': 'Phonological Components Analysis (PCA)', 'type': 'BEHAVIORAL', 'description': 'Anomia treatment focuses on improving word-finding abilities. This intervention targets the phonology of words to improve word-finding.', 'armGroupLabels': ['PCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'UB Audiology and Speech-Language Pathology Clinic', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Nichol Castro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sample size is low increasing risk of identification of individuals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nichol Castro', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}