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Heart Rate Changes in Subjects With Epilepsy | Clinical Trials | Clareo Health

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COMPLETEDNCT01202669

Heart Rate Changes in Subjects With Epilepsy

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

Lead sponsor: Cyberonics, Inc.•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cyberonics, Inc.

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.

Age

All ages

Sex

ALL

Healthy Volunteers

No

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

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 7, 2014Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment98

Start dateAug 2010

Last updatedAug 7, 2014

Condition

Locations shown

University of Florida

Gainesville, Florida

University of Chicago

Chicago, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2014Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions