Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00610558
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2008-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neocortical Epilepsies - Do They Progress?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msu@uci.edu', 'phone': '(949) 824-4925', 'title': 'Dr. Lydia Su', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Subjects monitored for safety events during the entire imaging session; up to 1 hour', 'description': 'All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Juvenile Myoclonic Epilepsy', 'description': '15 Subjects were monitored/assessed, but none observed', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Frontal Lobe Epilepsy', 'description': '14 Subjects were monitored/assessed, but none observed', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3: Normal Controls', 'description': '14 Subjects were monitored/assessed, but none observed', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding, soreness or swelling of injection site', 'notes': 'Bleeding, soreness or swelling may develop at injection site.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Allergic reactions to the contrasts', 'notes': 'Allergic reactions to the radiopharmaceutical may occur, but are extremely rare.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional Connectivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Juvenile Myoclonic Epilepsy', 'description': 'Subjects who are eligible to Juvenile Myoclonic Epilepsy will participate the imaging study'}, {'id': 'OG001', 'title': 'Arm 2: Frontal Lobe Epilepsy', 'description': 'Subjects who are eligible to Frontal Lobe Epilepsy will participate the imaging study'}, {'id': 'OG002', 'title': 'Arm 3: Normal Controls', 'description': 'Subjects who are eligible to the control group will participate the imaging study'}], 'timeFrame': 'During Imaging Session', 'description': 'We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'This protocol has been closed about 10 years ago. All files have been destroyed per IRB requirement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Juvenile Myoclonic Epilepsy', 'description': 'Subjects who are eligible for this group will participate MRI imaging'}, {'id': 'FG001', 'title': 'Arm 2: Frontal Lobe Epilepsy', 'description': 'Subjects who are eligible for this group will participate MRI imaging'}, {'id': 'FG002', 'title': 'Arm 3: Normal Cont', 'description': 'Subjects who are eligible for this group will participate MRI imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'There is no pre-assignment for this study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm1: Juvenile Myoclonic Epilepsy', 'description': 'Subject will are eligible for this group will participate the MRI imaging'}, {'id': 'BG001', 'title': 'Arm 2: Frontal Lobe Epilepsy', 'description': 'Subject will are eligible for this group will participate the MRI imaging'}, {'id': 'BG002', 'title': 'Arm 3: Normal Controls', 'description': 'Subject will are eligible for this group will participate the MRI imaging'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '37', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '40', 'spread': '7.7', 'groupId': 'BG002'}, {'value': '38.3', 'spread': '7.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The imaging data of Arm 3 will be the baseline to compare the difference to the imaging data in Arm 1 and Arm 2. We used an MRI-based with high angular resolution imaging examination of adult human brains. We compared the connectivity patterns in control subjects versus patients with Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy,'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2008-01-12', 'resultsFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2008-01-25', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-01', 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Connectivity', 'timeFrame': 'During Imaging Session', 'description': 'We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study will use MRI and PET scan to compare the brain imaging results between epilepsy patients and normal healthy controls, also to study changes in 3 years.', 'detailedDescription': 'We would like to continue analyzing the structural and metabolic differences between two epilepsy groups (JME and FLE) and the control to understand the imaging presentations of epilepsy patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Controls (20 Subjects):\n\nInclusion criteria:\n\n* Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below).\n\nExclusion criteria:\n\n* History of seizures, faints, or any unexplained blackouts.\n* Use of neuroleptic medications or sedating doses of antianxiety or antidepressant drugs.\n* They should not have a clear family history of epilepsy (first degree relatives).\n* History of any substance abuse within the past 5 years.\n* History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.\n* History of stroke without complete recovery of neurologic function.\n* Pregnancy\n* With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.\n* Inability to understand the consent. (standard form attached)\n* Inability to speak fluent English. Note: the neuropsychological tests are standardized for English speakers. They are not all available in multiple languages. Since the scoring and norms are established for English speakers, simply translating them would still not make the testing norms and scoring applicable.\n\nJuvenile Myoclonic Epilepsy (JME; 20 Subjects):\n\nInclusion Criteria:\n\n* Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus\n* History of myoclonic plus tonic-clonic or clonic-tonic-clonic seizures with or without absence seizures.\n* EEG consistent with primary generalized epilepsy (\\>/= 3 c/s generalized, frontal maximum, poly spike and wave; normal alpha)\n\nExclusion Criteria\n\n* History of significant head injury (\\> 30 min loss of consciousness)\n* Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs\n* History of any substance abuse within the past 5 years\n* Presence of epileptogenic brain lesion on MRI (tumor, stroke, cortical congenital dysplasia, etc; excluding normal variants, mild subcortical white matter ischemic change, venous angiomas).\n* EEG with focal epileptiform potentials or polymorphic slowing\n* History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.\n* History of stroke without complete recovery of neurologic function.\n* Pregnancy\n* With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.\n* Inability to speak fluent English\n\nFrontal Lobe Epilepsy (FLE; 20 Subjects):\n\nInclusion Criteria\n\n* Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus:\n* Seizure semiology (behavior) consistent with FLE\n* Interictal EEG spikes consistent with FLE or\n* Ictal video-EEG consistent with FLE\n* Frontal lobe lesion of MRI\n* Frontal hypometabolism on FDG-PET\n\nExclusion Criteria:\n\n* Presence of seizure semiology, ictal EEG, interictal EEG, MRI or PET findings that are not consistent with a frontal lobe epilepsy focus.\n* Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs\n* History of any substance abuse within the past 5 years\n* History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.\n* History of stroke without complete recovery of neurologic function.\n* Pregnancy\n* With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.\n* Absence of either a radial or ulnar arterial pulse\n* Inability to speak fluent English"}, 'identificationModule': {'nctId': 'NCT00610558', 'briefTitle': 'Neocortical Epilepsies - Do They Progress?', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Neocortical Epilepsies - Do They Progress?', 'orgStudyIdInfo': {'id': 'UCI-HS-2003-3252'}, 'secondaryIdInfos': [{'id': 'VA-821/103', 'type': 'OTHER', 'domain': 'VAMC West Los Angeles'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Juvenile Myoclonic Epilepsy', 'description': 'Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment', 'interventionNames': ['Device: Arm 1: Juvenile Myoclonic Epilepsy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Frontal Lobe Epilepsy', 'description': 'Frontal Lobe Epilepsy group of subjects will participate for imaging assessment', 'interventionNames': ['Device: Arm 2: Frontal Lobe Epilepsy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Normal Controls', 'description': "Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group", 'interventionNames': ['Device: Arm 3: Normal Controls']}], 'interventions': [{'name': 'Arm 1: Juvenile Myoclonic Epilepsy', 'type': 'DEVICE', 'description': 'Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI', 'armGroupLabels': ['Arm 1: Juvenile Myoclonic Epilepsy']}, {'name': 'Arm 2: Frontal Lobe Epilepsy', 'type': 'DEVICE', 'description': 'Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI', 'armGroupLabels': ['Arm 2: Frontal Lobe Epilepsy']}, {'name': 'Arm 3: Normal Controls', 'type': 'DEVICE', 'description': 'Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI', 'armGroupLabels': ['Arm 3: Normal Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Center for Functional Onco-Imaging, University of California', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Min-Ying Su, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Min-Ying (Lydia) Su', 'investigatorAffiliation': 'University of California, Irvine'}}}}