Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy
NCT ID: NCT01214707
Last Updated: 2012-03-15
Study Results
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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COMPLETED
30 participants
OBSERVATIONAL
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Exercise protocol
No arms are required for this study as all subjects complete the entire protocol
Exercise
Exercise during EMU stay
Interventions
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Exercise
Exercise during EMU stay
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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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
KUMC
Kansas City, Kansas, United States
Countries
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Other Identifiers
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E-31
Identifier Type: -
Identifier Source: org_study_id
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