Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02551705
Status:
UNKNOWN
Last Update Posted:
2015-09-16
First Post:
2015-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Imaging of Social Cognition in Premanifest Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059907', 'term': 'Functional Neuroimaging'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant group differences in brain activation for perceiving emotional vs neutral faces by following random effects analyses', 'timeFrame': '6 months', 'description': 'Significant group differences in beta-values for the contrast emotional faces vs neutral faces following general linear model parameter estimates'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Huntington's Disease"]}, 'descriptionModule': {'briefSummary': "Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the western world it affects 5-10 persons per 100000. The main brain changes include the loss of brain cells in subcortical structures. The symptoms of HD include involuntary movements, cognitive deterioration and behavioural disturbances. It has been shown that changes in emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in perception of emotions has been primarily investigated by means of facial expressions. However, emotions can also be expressed through body language. Here, the investigators propose to investigate whether the emotion comprehension deficit in preHD also includes body language comprehension.", 'detailedDescription': 'The investigators will perform a detailed evaluation of body language comprehension abilities in persons that carry the genetic mutation causing HD, but who do not show any movement symptoms yet. In addition, the associated changes in brain structure and function will be studied. The aim is to perform the study with the same group of participants who participated in a recent study carried on by this research group, in which the functional brain changes associated with increased irritability were investigated. This will allow to relate emotion experience with emotion perception. The results of the study may provide a target to further develop therapeutic interventions and aid caregivers of preHD subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Huntington's disease positive genotype and non-carrier siblings\n\nExclusion Criteria:\n\n* visible chorea\n* MRI contra-indications\n* major neurological/psychiatric comorbidity"}, 'identificationModule': {'nctId': 'NCT02551705', 'acronym': 'FISCIP', 'briefTitle': "Functional Imaging of Social Cognition in Premanifest Huntington's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': "Functional Imaging of Social Cognition in Premanifest Huntington's Disease", 'orgStudyIdInfo': {'id': 'S58457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'functional Imaging mutation carrier', 'description': 'Premanifest mutation carrier, behavioral and neural emotional memory processing', 'interventionNames': ['Other: functional Imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'functional Imaging non-carrier', 'description': 'non-carrier family member, behavioral and neural emotional memory processing', 'interventionNames': ['Other: functional Imaging']}], 'interventions': [{'name': 'functional Imaging', 'type': 'OTHER', 'description': 'Brain responses associated with emotional memory will be investigated', 'armGroupLabels': ['functional Imaging mutation carrier', 'functional Imaging non-carrier']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-doctoral researcher', 'investigatorFullName': 'Jan Van den Stock', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}