Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-29 @ 2:07 PM
Study NCT ID:
NCT01486056
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECG Vector Determination
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': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To correlate ECG amplitude with prospective VNS implant sites.', 'timeFrame': 'up to 2 days', 'description': 'This study is designed to collect ECG data to determine the process for proper generator and lead placement.'}], 'secondaryOutcomes': [{'measure': 'To identify potential VNS implant sites associated with low ECG amplitudes.', 'timeFrame': 'up to 2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epilepsy', 'ECG', 'device placement'], '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.'}, {'type': 'BACKGROUND', 'citation': "O'Donovan C, Burgess R, Luders H., Computerized seizure detection based on heart rate changes. Epilepsia 1995;36(suppl 4):7."}, {'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': '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': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.', 'detailedDescription': "This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data and determine the process for proper generator and lead placement. The study will be conducted in two phases: Phase I includes ECG data collection from human subjects; Phase II, the Implant Instructions for Use will be evaluated by Cyberonics' Clinical Engineers based on the activities of five to eight experienced VNS surgeons."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 12 years and older in general good health, preferably with epilepsy and on at least 1 antiepileptic medication.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II.\n2. Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study.\n\nExclusion Criteria:\n\n1. History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator.\n2. Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.\n3. History of physical adverse reaction to adhesive electrodes.'}, 'identificationModule': {'nctId': 'NCT01486056', 'briefTitle': 'ECG Vector Determination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cyberonics, Inc.'}, 'officialTitle': 'ECG Vector Determination for Model 106 Generator Implant Site Selection', 'orgStudyIdInfo': {'id': 'E-35'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy patients, may have epilepsy', 'description': 'Subjects at least 12 years old and in general good health for Phase I, and at least 18 years old and in general good health for Phase II. It is desired, but not required, for subjects to have epilepsy and taking at least 1 antiepileptic medication.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Douglas Denham, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Trails of Texas, Inc.'}, {'name': 'Bryan Olin, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cyberonics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyberonics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}