Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT03160235
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D004569', 'term': 'Electroencephalography'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Magnetic resonance imaging'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Methodological development of new MRI approaches'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatial resolution of new MRI imaging sequences MRI scanning.', 'timeFrame': 'Two hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Magnetic Resonance Imaging']}, 'descriptionModule': {'briefSummary': 'Studies that will be carried out on healthy volunteers will have as main objective the development and optimization of the parameters of sequences or the design of the paradigms of stimulation in order to optimize the quality and the relevance of the images realized taking in Taking account of anatomical, functional or metabolic parameters, or integrating new approaches resulting from technical evolutions', 'detailedDescription': 'The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular. The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks. The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form. These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major voluntary patients\n* socially insured.\n* Karnofsky score above 60%.\n* given their consent.\n* absence of contraindication to the MRI examination\n\nExclusion Criteria:\n\n* Subjects under the age of 18\n* pregnant women\n* persons referred to in articles L1121-5 to L1121-8 of the CSP.\n* Patients with acute illness'}, 'identificationModule': {'nctId': 'NCT03160235', 'acronym': 'MAP-PV', 'briefTitle': 'Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients', 'orgStudyIdInfo': {'id': '38RC12.239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Development of MRI protocols', 'description': 'MRI exam to grade differents interventions for future research', 'interventionNames': ['Radiation: Magnetic resonance imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Development of EEG protocols', 'description': 'EEF exam to grade differents interventions for future research', 'interventionNames': ['Device: EEG']}, {'type': 'EXPERIMENTAL', 'label': 'Development of NIRS protocols', 'description': 'NIRS exam to grade differents interventions for future research', 'interventionNames': ['Device: NIRS']}], 'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'RADIATION', 'armGroupLabels': ['Development of MRI protocols']}, {'name': 'EEG', 'type': 'DEVICE', 'armGroupLabels': ['Development of EEG protocols']}, {'name': 'NIRS', 'type': 'DEVICE', 'armGroupLabels': ['Development of NIRS protocols']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble-Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}