Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 5:25 PM
Study NCT ID:
NCT00431457
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2007-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2007-02-02', 'studyFirstSubmitQcDate': '2007-02-02', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up.', 'timeFrame': '6 months'}, {'measure': 'To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up.', 'timeFrame': 'at 6 and 12 months of follow-up'}], 'secondaryOutcomes': [{'measure': 'To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.', 'timeFrame': 'at 12 months of follow-up'}, {'measure': 'responder rates during 3 month intervals', 'timeFrame': '3 months intervals'}, {'measure': 'mean seizure free interval during 3 month intervals', 'timeFrame': '3 month intervals'}, {'measure': 'seizure severity and seizure type during 3-month intervals', 'timeFrame': '3-month intervals'}, {'measure': 'quality of life: changes in QOLIE 89 score at 6 and 12 months', 'timeFrame': 'at 6 and 12 months'}, {'measure': 'mood assessment: changes in Beck depression scale scores at 6 and 12 month', 'timeFrame': 'at 6 and 12 month'}, {'measure': 'Safety Objectives:', 'timeFrame': 'during twelve months after inclusion'}, {'measure': 'Operative and postoperative complications and long-term side effects', 'timeFrame': 'during twelve months after inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '24777136', 'type': 'DERIVED', 'citation': 'Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16.'}], 'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Patients will be prospectively randomized to 3 different treatment arms:\n\n* Treatment group 1: patients who undergo medial temporal lobe resection\n* Treatment group 2: patients who receive immediate hippocampal neurostimulation\n* Treatment group 3: patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months.\n\nTwelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery.\n\nStudy visits will occur every 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of temporal lobe epilepsy\n* Age above 18 years\n* TIQ \\> 80\n* Able to give informed consent\n* Average of 2 partial seizures per month during a baseline of 3 months. Recording of seizures must have been done in a prospective manner using standard seizure diaries.\n* Able to adequately report seizure frequencies using standard seizure diaries\n* Video-EEG characteristics showing temporal lobe seizure onset (left-sided or right-sided seizure onset) in at least one recorded habitual seizure\n* Presence of a structural abnormality in the medial temporal lobe, suggestive of hippocampal sclerosis as evidenced by optimum MRI\n* Women of child-bearing age will be required to use a reliable method of contraception during the study duration\n\nExclusion Criteria:\n\n* Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial temporal lobe epilepsy\n* MR evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas\n* Prior resective intracranial surgery\n* Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording\n* Patients who previously underwent any other type of neurostimulation for treating epilepsy\n* Patients who are unable to fill in questionnaires and comply with protocol requirements\n* Progressive neurological or medical conditions\n* Medical or psychiatric conditions precluding surgery or compliance\n* Patients taking antidepressant medication\n* Pregnancy at study onset\n* Previous (within the last 3 months), ongoing or planned participation in other treatment study protocols for epilepsy\n* Contraindication for intracranial surgery'}, 'identificationModule': {'nctId': 'NCT00431457', 'briefTitle': 'Controlled Randomized Stimulation Versus Resection (CoRaStiR)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Prospective Randomized Controlled Study of Neurostimulation in the Medial Temporal Lobe for Patients With Medically Refractory Medial Temporal Lobe Epilepsy; Controlled Randomized Stimulation Versus Resection (CoRaStiR)', 'orgStudyIdInfo': {'id': '2007/005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Implantation intracranial electrode with immediate stimulation', 'interventionNames': ['Device: Implantation of an intracranial electrode']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Implantation intracranial electrode without stimulation', 'interventionNames': ['Device: Implantation of an intracranial electrode']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resective surgery: amygddohyppocampertomy', 'interventionNames': ['Procedure: amygddohyppocampertomy']}], 'interventions': [{'name': 'Implantation of an intracranial electrode', 'type': 'DEVICE', 'description': 'Implantation of an intracranial electrode will be followed.', 'armGroupLabels': ['Implantation intracranial electrode with immediate stimulation', 'Implantation intracranial electrode without stimulation']}, {'name': 'amygddohyppocampertomy', 'type': 'PROCEDURE', 'description': 'Resective surgery', 'armGroupLabels': ['Resective surgery: amygddohyppocampertomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'UKB Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Paul Boon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}