Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-07 @ 6:53 AM
Study NCT ID:
NCT02134561
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007406', 'term': 'Interview, Psychological'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D011581', 'term': 'Psychological Tests'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years", 'timeFrame': '3 months before diagnostic (baseline) ; 2 years after diagnostic,'}]}, 'conditionsModule': {'conditions': ['Presymptomatic Huntington Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Applicants for Huntington's Disease and Presymptomatic Testing\n* Aged 18 years and above\n* Huntington disease family member\n* Subject gave its written consent\n\nExclusion Criteria:\n\n* No national health insurance affiliation\n* Being under guardianship\n* Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI.\n* Patient with movement disorder"}, 'identificationModule': {'nctId': 'NCT02134561', 'acronym': 'PREHUNT', 'briefTitle': "Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing", 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'orgStudyIdInfo': {'id': '2013-A00088-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'psychological interview, MRI, neurological tests, cognitive tests', 'interventionNames': ['Behavioral: psychological interview', 'Radiation: MRI', 'Other: cognitive tests', 'Other: neurological tests']}], 'interventions': [{'name': 'psychological interview', 'type': 'BEHAVIORAL', 'armGroupLabels': ['All subjects']}, {'name': 'MRI', 'type': 'RADIATION', 'description': "This MRI is a specific intervention assign to the subjects of the study, that's why it is an interventionnal study", 'armGroupLabels': ['All subjects']}, {'name': 'cognitive tests', 'type': 'OTHER', 'armGroupLabels': ['All subjects']}, {'name': 'neurological tests', 'type': 'OTHER', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'University Hospital of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}