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ECG Vector Determination

NCT ID: NCT01486056

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.

Detailed Description

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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.

Conditions

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Epilepsy

Keywords

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epilepsy ECG device placement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.

Exclusion Criteria

1. 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.
2. Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
3. History of physical adverse reaction to adhesive electrodes.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cyberonics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Denham, DO

Role: PRINCIPAL_INVESTIGATOR

Clinical Trails of Texas, Inc.

Bryan Olin, Ph.D

Role: STUDY_DIRECTOR

Cyberonics, Inc.

Locations

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Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 13618449 (View on PubMed)

Marshall DW, Westmoreland BF, Sharbrough FW. Ictal tachycardia during temporal lobe seizures. Mayo Clin Proc. 1983 Jul;58(7):443-6.

Reference Type BACKGROUND
PMID: 6865478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2818251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2465123 (View on PubMed)

O'Donovan C, Burgess R, Luders H., Computerized seizure detection based on heart rate changes. Epilepsia 1995;36(suppl 4):7.

Reference Type 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.

Reference Type BACKGROUND
PMID: 10413832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12614390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15066542 (View on PubMed)

Other Identifiers

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E-35

Identifier Type: -

Identifier Source: org_study_id