Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT03459651
Status:
WITHDRAWN
Last Update Posted:
2022-05-09
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Turner Syndrome on Number Sense
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014424', 'term': 'Turner Syndrome'}], 'ancestors': [{'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator elected to end the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single and multiple-operand addition and subtraction accuracy', 'timeFrame': '8 weeks', 'description': 'Task accuracy calculated as the percentage of trials answered correctly.'}, {'measure': 'Single and multiple-operand addition and subtraction response time', 'timeFrame': '8 weeks', 'description': 'Average amount of time, in seconds, required to answer each question on the task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['numeracy', 'number sense'], 'conditions': ['Turner Syndrome']}, 'descriptionModule': {'briefSummary': 'This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Participants will undergo weekly training sessions in their own home. Half of the participants will complete 2 training sessions a week for 8 weeks, and the second half will complete 1 training session for 8 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children, adolescents, and adult women with Turner syndrome.\n* Healthy controls.\n* Normal or corrected to normal vision.\n\nExclusion Criteria:\n\n* Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder).\n* Chemical dependency\n* Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.'}, 'identificationModule': {'nctId': 'NCT03459651', 'briefTitle': 'Effect of Turner Syndrome on Number Sense', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Investigation of the Role of Turner Syndrome on Approximate Number Sense', 'orgStudyIdInfo': {'id': '092883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANS training', 'interventionNames': ['Behavioral: ANS training']}], 'interventions': [{'name': 'ANS training', 'type': 'BEHAVIORAL', 'description': 'In-home computer-based ANS training', 'armGroupLabels': ['ANS training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Center for Interdisciplinary Brain Sciences Research', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified individual participant data for the primary outcome measures may be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Joseph Michael Baker', 'investigatorAffiliation': 'Stanford University'}}}}