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

NCT ID: NCT01214707

Last Updated: 2012-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Brief Summary

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

Detailed Description

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

Conditions

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Epilepsy

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Exercise protocol

No arms are required for this study as all subjects complete the entire protocol

Exercise

Intervention Type OTHER

Exercise during EMU stay

Interventions

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Exercise

Exercise during EMU stay

Intervention Type OTHER

Other Intervention Names

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Exercise during EMU stay. No treatment intervention.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cyberonics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Treiman, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute Phoenix AZ

Ivan Osorio, MD

Role: PRINCIPAL_INVESTIGATOR

KUMC Kansas City, Kansas

Locations

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BNI

Phoenix, Arizona, United States

Site Status

KUMC

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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E-31

Identifier Type: -

Identifier Source: org_study_id

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