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Heart Rate Changes in Subjects With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202669
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
Cyberonics, Inc.

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

Condition or disease Intervention/treatment
Epilepsy Other: No intervention planned, observational study only.

Detailed 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.

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission
Study Start Date : August 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Epilepsy patients, EMU stay Other: No intervention planned, observational study only.
No intervention planned, observational study only.

Primary Outcome Measures :
  1. Collection of physiologic data during an Epilepsy Monitoring Unit (EMU) stay [ Time Frame: up to 7 days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Epilepsy patients indicated for epilepsy monitoring unit stay.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202669

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Cyberonics, Inc.
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Study Director: Bryan Olin Employee


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Responsible Party: Cyberonics, Inc. Identifier: NCT01202669     History of Changes
Other Study ID Numbers: E-30
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases