Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy

March 13, 2012 updated by: Cyberonics, Inc.
Characterization of the cardiac response (ECG) preceding an epileptic seizure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • BNI
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • KUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with epilepsy already scheduled for an EMU stay.

Description

Inclusion Criteria:

  1. Patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (EMU).
  2. Patient likely requires an EMU evaluation for a period of at least 3 days.
  3. In the opinion of the Principal Investigator, the Patient is likely to have 3 - 5 seizures during the EMU stay.
  4. Patient is currently taking at least one antiepileptic medication.
  5. Patients must be 18 years or older and may be of either sex and of any race.
  6. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
  7. Patient must be willing and able to complete informed consent and HIPAA authorization.
  8. Patient is diagnosed with epilepsy but may also experience pseudo seizures or psychogenic seizures.

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 experiencing status epileptic within the last 6 months.
  3. Patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk.
  4. 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.
  5. 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 and permanent cardiac pacemaker implantation.
  6. Patients currently dependent on alcohol or narcotic drugs as defined by DSM IV-R.
  7. Patients with a history of only psychogenic seizures or pseudo seizures.
  8. Women who are pregnant. Women of childbearing age must take a pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exercise protocol
No arms are required for this study as all subjects complete the entire protocol
Other: Exercise
Exercise during EMU stay
Other Names:
  • Exercise during EMU stay. No treatment intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Changes during Normal Activity, Exercise, and Seizures in Subjects with Epilepsy
Time Frame: 3 to 5 days
Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.
3 to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyberonics, Inc.

Investigators

  • Principal Investigator: David M Treiman, MD, Barrow Neurological Institute Phoenix AZ
  • Principal Investigator: Ivan Osorio, MD, KUMC Kansas City, Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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