Heart Rate Changes in Subjects With Epilepsy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01202669
First received: August 6, 2010
Last updated: January 31, 2013
Last verified: January 2013
  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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.
Other Name: 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 6, 2010
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014