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Heart Rate Changes in Subjects With Epilepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202669
First Posted: September 16, 2010
Last Update Posted: August 7, 2014
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.
Information provided by (Responsible Party):
Cyberonics, Inc.
  Purpose
The purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.

Condition Intervention
Epilepsy Other: No intervention planned, observational study only.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 98
Study Start Date: August 2010
Study Completion Date: July 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Epilepsy patients, EMU stay Other: No intervention planned, observational study only.
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.
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01202669


Locations
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.
Investigators
Study Director: Bryan Olin Employee
  More Information

Publications:

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01202669     History of Changes
Other Study ID Numbers: E-30
First Submitted: August 6, 2010
First Posted: September 16, 2010
Last Update Posted: August 7, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases