Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-28 @ 9:33 AM
Study NCT ID:
NCT01202669
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2010-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Changes in Subjects With Epilepsy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-06', 'studyFirstSubmitDate': '2010-08-06', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of physiologic data during an Epilepsy Monitoring Unit (EMU) stay', 'timeFrame': 'up to 7 days', 'description': 'To collect continuous observational video, electroencephalogram (EEG), electrooculogram (EOG), and electrocardiogram (ECG) data during ictal and non-ictal events occurring over a clinical EMU evaluation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '13618449', 'type': 'BACKGROUND', 'citation': 'VAN BUREN JM. Some autonomic concomitants of ictal automatism; a study of temporal lobe attacks. Brain. 1958 Dec;81(4):505-28. doi: 10.1093/brain/81.4.505. No abstract available.'}, {'pmid': '6865478', 'type': 'BACKGROUND', 'citation': 'Marshall DW, Westmoreland BF, Sharbrough FW. Ictal tachycardia during temporal lobe seizures. Mayo Clin Proc. 1983 Jul;58(7):443-6.'}, {'pmid': '2818251', 'type': 'BACKGROUND', 'citation': 'Keilson MJ, Hauser WA, Magrill JP. Electrocardiographic changes during electrographic seizures. Arch Neurol. 1989 Nov;46(11):1169-70. doi: 10.1001/archneur.1989.00520470023018.'}, {'pmid': '2465123', 'type': 'BACKGROUND', 'citation': 'Smith PE, Howell SJ, Owen L, Blumhardt LD. Profiles of instant heart rate during partial seizures. Electroencephalogr Clin Neurophysiol. 1989 Mar;72(3):207-17. doi: 10.1016/0013-4694(89)90245-9.'}, {'pmid': '10413832', 'type': 'BACKGROUND', 'citation': 'Schernthaner C, Lindinger G, Potzelberger K, Zeiler K, Baumgartner C. Autonomic epilepsy--the influence of epileptic discharges on heart rate and rhythm. Wien Klin Wochenschr. 1999 May 21;111(10):392-401.'}, {'pmid': '15066542', 'type': 'BACKGROUND', 'citation': 'Di Gennaro G, Quarato PP, Sebastiano F, Esposito V, Onorati P, Grammaldo LG, Meldolesi GN, Mascia A, Falco C, Scoppetta C, Eusebi F, Manfredi M, Cantore G. Ictal heart rate increase precedes EEG discharge in drug-resistant mesial temporal lobe seizures. Clin Neurophysiol. 2004 May;115(5):1169-77. doi: 10.1016/j.clinph.2003.12.016.'}, {'pmid': '12614390', 'type': 'BACKGROUND', 'citation': 'Leutmezer F, Schernthaner C, Lurger S, Potzelberger K, Baumgartner C. Electrocardiographic changes at the onset of epileptic seizures. Epilepsia. 2003 Mar;44(3):348-54. doi: 10.1046/j.1528-1157.2003.34702.x.'}, {'pmid': '10580303', 'type': 'BACKGROUND', 'citation': 'Novak V, Reeves AL, Novak P, Low PA, Sharbrough FW. Time-frequency mapping of R-R interval during complex partial seizures of temporal lobe origin. J Auton Nerv Syst. 1999 Sep 24;77(2-3):195-202.'}, {'pmid': '1734323', 'type': 'BACKGROUND', 'citation': "Epstein MA, Sperling MR, O'Connor MJ. Cardiac rhythm during temporal lobe seizures. Neurology. 1992 Jan;42(1):50-3. doi: 10.1212/wnl.42.1.50."}, {'pmid': '12181003', 'type': 'BACKGROUND', 'citation': 'Zijlmans M, Flanagan D, Gotman J. Heart rate changes and ECG abnormalities during epileptic seizures: prevalence and definition of an objective clinical sign. Epilepsia. 2002 Aug;43(8):847-54. doi: 10.1046/j.1528-1157.2002.37801.x.'}, {'pmid': '16828317', 'type': 'BACKGROUND', 'citation': 'van Elmpt WJ, Nijsen TM, Griep PA, Arends JB. A model of heart rate changes to detect seizures in severe epilepsy. Seizure. 2006 Sep;15(6):366-75. doi: 10.1016/j.seizure.2006.03.005. Epub 2006 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.', 'detailedDescription': 'Observational, unblinded, non-randomized, multisite study designed to collect data on up to 500 subjects undergoing evaluation for epilepsy in EMUs. Subjects currently enrolled or that previously participated in this study may be eligible for the E-30-S sub-study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Epilepsy patients indicated for epilepsy monitoring unit stay.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients enrolled in the study must meet all of the following criteria:\n\n1. Patient has a clinical diagnosis of epilepsy requiring evaluation in an epilepsy monitoring unit (EMU).\n2. Patient likely requires an EMU evaluation for a period of at least 24 hours.\n3. Patient is currently taking at least one antiepileptic medication.\n4. Patient must be in good general health and fully ambulatory.\n5. Patient or guardian must be willing and able to complete informed consent/assent and HIPAA authorization.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria are not eligible to be enrolled in the study:\n\n1. Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.\n2. Patients with a history of status epilepticus.\n3. Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed.\n4. Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would include but not be limited to chronic atrial fibrillation, chronotropic incompetence, and permanent cardiac pacemaker implantation.\n5. Patients with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R."}, 'identificationModule': {'nctId': 'NCT01202669', 'briefTitle': 'Heart Rate Changes in Subjects With Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cyberonics, Inc.'}, 'officialTitle': 'Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission', 'orgStudyIdInfo': {'id': 'E-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epilepsy patients, EMU stay', 'interventionNames': ['Other: No intervention planned, observational study only.']}], 'interventions': [{'name': 'No intervention planned, observational study only.', 'type': 'OTHER', 'description': 'No intervention planned, observational study only.', 'armGroupLabels': ['Epilepsy patients, EMU stay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Bryan Olin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyberonics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}