Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-09 @ 3:09 PM
Study NCT ID:
NCT02886650
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004564', 'term': 'Electrocoagulation'}], 'ancestors': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of children with a decrease of at least 50% of the seizure frequency', 'timeFrame': 'one month after surgery'}]}, 'conditionsModule': {'keywords': ['Paediatrics', 'epilepsy surgery', 'genetic mutation', 'focal seizures'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 month to 17 years old\n* focal drug-resistant epilepsy\n* small size lesion (1 or 2 gyri) or cryptogenic epilepsy\n* indication for EEG monitoring with depth electrodes during presurgical evaluation\n\nExclusion Criteria:\n\n* formal contraindication to surgery or anaesthesia\n* functional area or potentially large epileptic area\n* refusal to participate in the study\n* no health insurance coverage'}, 'identificationModule': {'nctId': 'NCT02886650', 'acronym': 'COAG', 'briefTitle': 'Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'orgStudyIdInfo': {'id': 'MCX_2015_31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermocoagulation', 'interventionNames': ['Procedure: Thermocoagulation']}], 'interventions': [{'name': 'Thermocoagulation', 'type': 'PROCEDURE', 'description': 'Thermocoagulation During pre-surgical Invasive EEG Monitoring', 'armGroupLabels': ['Thermocoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence SALOMON, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Fondation Ophtalmologique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Laurence SALOMON, MD, PhD', 'role': 'CONTACT', 'email': 'lsalomon@for.paris', 'phone': '0033148036431'}], 'overallOfficials': [{'name': 'Mathilde CHIPAUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation OPH A de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}