Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT03039166
Status:
UNKNOWN
Last Update Posted:
2017-04-14
First Post:
2017-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Index of reorganization of the structural hubs (ks-Degree)', 'timeFrame': '5years'}], 'secondaryOutcomes': [{'measure': 'Concentrations of sodium within hubs', 'timeFrame': '5 years'}, {'measure': 'Concentrations of Glutamate/Glutamine within hubs', 'timeFrame': '5 years'}, {'measure': 'cortical Thicknesses within hubs', 'timeFrame': '5 years'}, {'measure': 'Iron accumulation within hubs', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Diseases']}, 'descriptionModule': {'briefSummary': "the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.\n\nThe objective here is to test this hypothesis and provides better understandings on pathophysiological processes affecting those highly connected regions in 'diffuse' and 'focal' neurological diseases.\n\nThe ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS, cognitive rehabilitation ...).\n\nPractically, the investigators will explore 200 patients classified in 5 cohorts of 40 patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to assess structural and functional brain connectivity implemented on the human 7T MR scanner equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).\n\nIn addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium) mapping will complement the MR protocol to characterize the pathophysiological processes of hub injury. Sixty healthy controls will also be explored wih the same protocol for normal database.\n\nThe proposal aims at characterizing and comparing from a morphological-functional point of view, the hub regions of patients suffering from these five diseases, to demonstrate the pertinence to preserve hub integrity as a major therapeutic target whatever the disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person female or male, more than 18-year-old,\n* Person presenting unchecked general disease such as severe cancer, autoimmune disease, hepatic insufficiency, severe or untreated, shady arterial high blood pressure of the conduction or the disorder of the rhythm\n* Person presenting chronic psychiatric disease, insane syndrome.\n* Person presenting contraindication to the realization of an examination by MRI (metallic claustrophobia, foreign body, pacemakers),\n* Person benefiting from a social security cover,\n* Person having read, understood and signed an informed consent after information\n\nExclusion Criteria:\n\n* Claustrophobia,\n* Metallic foreign bodies,\n* Pacemakers,\n* Severe renal insufficiency'}, 'identificationModule': {'nctId': 'NCT03039166', 'briefTitle': "Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': "Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI", 'orgStudyIdInfo': {'id': '2016-A01785-46'}, 'secondaryIdInfos': [{'id': '2016-46', 'type': 'OTHER', 'domain': 'Assistance Publique-Hôpitaux de Marseille'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'parkinson', 'interventionNames': ['Device: MRI 7T', 'Device: MRI 3 T']}, {'type': 'EXPERIMENTAL', 'label': 'partial epilepsy', 'interventionNames': ['Device: MRI 7T', 'Device: MRI 3 T']}, {'type': 'EXPERIMENTAL', 'label': 'alzheimer disease', 'interventionNames': ['Device: MRI 7T', 'Device: MRI 3 T']}, {'type': 'EXPERIMENTAL', 'label': 'multiple sclerosis', 'interventionNames': ['Device: MRI 7T', 'Device: MRI 3 T', 'Biological: blood sample']}, {'type': 'EXPERIMENTAL', 'label': 'amyotrophic lateral sclerosis', 'interventionNames': ['Device: MRI 7T', 'Device: MRI 3 T']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy control patients', 'interventionNames': ['Device: MRI 7T', 'Device: MRI 3 T']}], 'interventions': [{'name': 'MRI 7T', 'type': 'DEVICE', 'armGroupLabels': ['alzheimer disease', 'amyotrophic lateral sclerosis', 'healthy control patients', 'multiple sclerosis', 'parkinson', 'partial epilepsy']}, {'name': 'MRI 3 T', 'type': 'DEVICE', 'armGroupLabels': ['alzheimer disease', 'amyotrophic lateral sclerosis', 'healthy control patients', 'multiple sclerosis', 'parkinson', 'partial epilepsy']}, {'name': 'blood sample', 'type': 'BIOLOGICAL', 'armGroupLabels': ['multiple sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'ALEXANDRA GIULIANI', 'role': 'CONTACT', 'email': 'drci@ap-hm.fr'}, {'name': 'MAXIME GUYE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiatnce Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'maxime GUYE', 'role': 'CONTACT', 'email': 'maxime.guye@ap-hm.fr'}], 'overallOfficials': [{'name': 'Catherine GEINDRE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}