ECG Vector Determination

Epilepsy Clinical Trial

Official title:

ECG Vector Determination for Model 106 Generator Implant Site Selection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486056
• Other study ID #: E-35
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: August 20, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Keilson MJ, Hauser WA, Magrill JP. Electrocardiographic changes during electrographic seizures. Arch Neurol. 1989 Nov;46(11):1169-70. — View Citation

Leutmezer F, Schernthaner C, Lurger S, Pötzelberger K, Baumgartner C. Electrocardiographic changes at the onset of epileptic seizures. Epilepsia. 2003 Mar;44(3):348-54. — View Citation

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

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

Schernthaner C, Lindinger G, Pötzelberger 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. — View 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. — View Citation

VAN BUREN JM. Some autonomic concomitants of ictal automatism; a study of temporal lobe attacks. Brain. 1958 Dec;81(4):505-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To identify potential VNS implant sites associated with low ECG amplitudes.		up to 2 days	No