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

Characterization of the cardiac response (ECG) preceding an epileptic seizure.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: Exercise

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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

• 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

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: Exercise/No active Treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: E-31