Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT01794195
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2013-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D053609', 'term': 'Lethargy'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-30', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'Fibres density (number of fibres / voxel)', 'timeFrame': 'at day 1'}, {'measure': 'Bulk diffusivity index', 'timeFrame': 'at day 1'}, {'measure': 'Apparent diffusion coefficient', 'timeFrame': 'at day 1'}]}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Apathy', 'diffusion tensor imaging', 'tractography'], 'conditions': ["Parkinson's Disease", 'Apathy']}, 'descriptionModule': {'briefSummary': "Use lay language.\n\nApathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.\n\nApathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex\n\nThe objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods", 'detailedDescription': "3 groups :\n\n* 20 apathetic patients with Parkinson's disease\n* 20 non apathetic paired patients)\n* 20 healthy paired control\n\nDescription of the protocol for patients :\n\nJ0 : Inclusion visit (duration : 4h):\n\n* motor assessment (UPDRS)\n* neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille apathy rating scale (LARS) ; Starkstein scale.\n\nDepression assessment : Montgomery et Alsberg depression rating scale (MADRS)\n\nJ0+1 day : MRI (magnetic resonance imaging) acquisition (30 minutes) Multimodal MRI examinations will be performed (Diffusion-weighted data and high-resolution 3-dimensional (3D) T1- weighted as well as T2-weighted images) on each subject on a GE 3-T."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\-\n\nPatients :\n\n* Men or women aged between 18 -85 years\n* Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias\n* Non dement (MMS ≥ 26 ; MATTIS ≥ 130)\n* Affiliated to National Health system\n* Having given their informed consent\n\nHealthy controls\n\n* Men or women aged between 18 -85 years\n* Affiliated to National Health system\n* Having given their informed consent\n\nExclusion Criteria:\n\n* Patients :\n* Patients suffering of an atypical Parkinson syndrome\n* Psychiatric pathology\n* Severe tremor form of PD\n* Depression (MADRS \\>16)., dementia (MMS \\< 26, MATTIS \\< 130).\n* Pregnant\n* Under guardianship\n* In excluding period for another study\n* Any contra-indication to MRI\n\nHealthy subject\n\n* Subject with neurological, psychiatric diseases\n* Depression, dementia, apathy\n* Pregnant\n* Under guardianship\n* In excluding period for another study\n* Any contra-indication to MRI"}, 'identificationModule': {'nctId': 'NCT01794195', 'briefTitle': "Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': "Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking", 'orgStudyIdInfo': {'id': 'CHU-0145'}, 'secondaryIdInfos': [{'id': '2012-A01293-40'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "apathetic patients with Parkinson's disease", 'description': "The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods", 'interventionNames': ['Behavioral: Diffusion tensor imaging and fibres tracking']}, {'type': 'EXPERIMENTAL', 'label': 'non apathetic paired patients', 'description': "The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods", 'interventionNames': ['Behavioral: Diffusion tensor imaging and fibres tracking']}, {'type': 'EXPERIMENTAL', 'label': 'healthy paired control', 'description': "The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods", 'interventionNames': ['Behavioral: Diffusion tensor imaging and fibres tracking']}], 'interventions': [{'name': 'Diffusion tensor imaging and fibres tracking', 'type': 'BEHAVIORAL', 'armGroupLabels': ["apathetic patients with Parkinson's disease", 'healthy paired control', 'non apathetic paired patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Franck DURIF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}