Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT03586258
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2018-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D059906', 'term': 'Neuroimaging'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Deficit', 'timeFrame': '3 months to more than 2 years', 'description': 'The cognitive deficit of interest will depend on the localization of the brain lesion. The outcome measure could be a standardized neuropsychological test or an experimental test specifically elaborated for this protocol.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropsychological study', 'Brain imaging'], 'conditions': ['Cerebrovascular Disorders', 'Brain Lesion', 'Degenerative Disease', 'Developmental Disability']}, 'descriptionModule': {'briefSummary': 'Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects.\n\nThe objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 17 years\n* French language\n* Effective contraception for women during the study\n* Informed consent\n* No alcohol intake the day before the exam\n* For patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology, developmental or degenerative disease with cognitive deficit\n\nExclusion Criteria:\n\n* For healthy volunteers: previous neurological history (except non complicated migraine or epilepsy), previous psychiatric history (except depression with good evolution or anxiety), or severe cranial traumatism\n* For patients: vigilance disorders, severe depression or anxiety.\n* For both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for MRI or GVS if applicable, participation in another trial or former involvement in another trial within one month.'}, 'identificationModule': {'nctId': 'NCT03586258', 'acronym': 'CORAC2', 'briefTitle': 'Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)', 'orgStudyIdInfo': {'id': '2017-A03062-51'}, 'secondaryIdInfos': [{'id': '2017-A03062-51', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain Damaged Subjects', 'description': 'Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders', 'interventionNames': ['Behavioral: Neuropsychological testing', 'Other: Brain Imaging', 'Other: Galvanic Vestibular Stimulation (GVS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy Volunteers', 'description': 'Healthy Controls', 'interventionNames': ['Behavioral: Neuropsychological testing', 'Other: Brain Imaging', 'Other: Galvanic Vestibular Stimulation (GVS)']}], 'interventions': [{'name': 'Neuropsychological testing', 'type': 'BEHAVIORAL', 'description': 'Experimental test about cognitive deficit of interest and standard neuropsychological tests', 'armGroupLabels': ['Brain Damaged Subjects', 'Healthy Volunteers']}, {'name': 'Brain Imaging', 'type': 'OTHER', 'description': 'Anatomical, diffusion, and/or functional MRI', 'armGroupLabels': ['Brain Damaged Subjects', 'Healthy Volunteers']}, {'name': 'Galvanic Vestibular Stimulation (GVS)', 'type': 'OTHER', 'description': 'Stimulation versus Sham', 'armGroupLabels': ['Brain Damaged Subjects', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier MARTINAUD, MD, PhD', 'role': 'CONTACT', 'email': 'martinaud-o@chu-caen.fr', 'phone': '2 31 06 46 17', 'phoneExt': '+33'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Olivier MARTINAUD, MD, PhD', 'role': 'CONTACT', 'email': 'martinaud-o@chu-caen.fr', 'phone': '2 31 06 46 17', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Olivier MARTINAUD, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caen University Hospital, Normandie UNIV, UNICAEN, PSL Research University, EPHE, Inserm, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, 14000 Caen, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}