Heart Rate Changes in Subjects With Epilepsy

Epilepsy Clinical Trial

Official title:

Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202669
• Other study ID #: E-30
• Status: Completed
• Phase: N/A
• First received: August 6, 2010
• Last updated: August 6, 2014
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients enrolled in the study must meet all of the following criteria:

1. Patient has a clinical diagnosis of epilepsy requiring evaluation in an epilepsy monitoring unit (EMU).

2. Patient likely requires an EMU evaluation for a period of at least 24 hours.

3. Patient is currently taking at least one antiepileptic medication.

4. Patient must be in good general health and fully ambulatory.

5. Patient or guardian must be willing and able to complete informed consent/assent and HIPAA authorization.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible to be enrolled in the study:

1. Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.

2. Patients with a history of status epilepticus.

3. 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.

4. 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.

5. Patients with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• No intervention planned, observational study only.
No intervention planned, observational study only.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

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

Epstein MA, Sperling MR, O'Connor MJ. Cardiac rhythm during temporal lobe seizures. Neurology. 1992 Jan;42(1):50-3. — 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

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. — View Citation

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

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. Epub 2006 Jul 7. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of physiologic data during an Epilepsy Monitoring Unit (EMU) stay	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.	up to 7 days	No