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This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy patients, may have epilepsy | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| To correlate ECG amplitude with prospective VNS implant sites. | This study is designed to collect ECG data to determine the process for proper generator and lead placement. | up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| To identify potential VNS implant sites associated with low ECG amplitudes. | up to 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 12 years and older in general good health, preferably with epilepsy and on at least 1 antiepileptic medication.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Denham, DO | Clinical Trails of Texas, Inc. | Principal Investigator |
| Bryan Olin, Ph.D | Cyberonics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13618449 | Background | 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. | |
| 6865478 | Background | Marshall DW, Westmoreland BF, Sharbrough FW. Ictal tachycardia during temporal lobe seizures. Mayo Clin Proc. 1983 Jul;58(7):443-6. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 2818251 | Background | 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. |
| 2465123 | Background | 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. |
| Background | O'Donovan C, Burgess R, Luders H., Computerized seizure detection based on heart rate changes. Epilepsia 1995;36(suppl 4):7. |
| 10413832 | Background | 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. |
| 12614390 | Background | 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. |
| 15066542 | Background | 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. |