Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 7:19 PM
Study NCT ID:
NCT01919957
Status:
UNKNOWN
Last Update Posted:
2015-02-06
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of successfull encoding', 'timeFrame': '8 years', 'description': 'Our goal is to define correlation between the measure of successfull object encoding trials (especially for binding) and the beta value activation in fMRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epilepsy', 'surgery', 'functional MRI', 'memory outcome'], 'conditions': ['Epilepsy, Unspecified, Pharmacologically Resistant', 'Memory Impairment']}, 'descriptionModule': {'briefSummary': 'This study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation therapies.\n\nMemory performances during a fMRI experiment will be assessed in controls and epileptic patients before and after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with drug-resistant epilepsy\n* Age of 18 years or more\n* Follow-up in the epilepsy unit at Pitié-Salpêtrière Hospital\n* Before or after the presurgical evaluation unit including a video-EEG monitoring, a structural brain imaging and a full neuropsychological assessment\n* Covered by a social security system\n* Signing of consent form\n\nExclusion Criteria:\n\n* Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom\n* Refusal to consent form\n* Contraindications to MRI\n* Pregnancy\n* Refusal to be informed in the case of detection of an abnormality during the experiment'}, 'identificationModule': {'nctId': 'NCT01919957', 'acronym': 'MemO-Epi', 'briefTitle': 'Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "Etude de la mémoire Avant et après Chirurgie d'Une épilepsie Partielle pharmacorésistante : Bases Neurobiologiques, Applications Cliniques", 'orgStudyIdInfo': {'id': 'C12-11'}, 'secondaryIdInfos': [{'id': '2013-A00343-42', 'type': 'REGISTRY', 'domain': 'C12-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'memory outcome', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['memory outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75651', 'city': 'Paris', 'state': 'Cedex 13', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Dupont, MD, PhD', 'role': 'CONTACT', 'email': 'sophie.dupont@psl.aphp.fr', 'phone': '01 42 17 85 23', 'phoneExt': '+33'}, {'name': 'Virginie Lambrecq, MD', 'role': 'CONTACT', 'email': 'vlambrecq@hotmail.fr'}, {'name': 'Sophie Dupont, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Virginie Lambrecq, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Véra Dinkelacker, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stéphane Lehéricy, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lionel Thivard, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claude Adam, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sophie DUPONT, MD, PhD', 'role': 'CONTACT', 'email': 'sophie.dupont@psl.aphp.fr', 'phone': '01 42 17 85 23', 'phoneExt': '+33'}, {'name': 'Virginie LAMBRECQ, MD', 'role': 'CONTACT', 'email': 'vlambrecq@hotmail.fr'}], 'overallOfficials': [{'name': 'Sophie Dupont, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service de Soins de Suites et Réadaptation Neurologique, Hôpital de la Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75651 Paris Cedex 13"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}