Heart Rate Changes in Subjects With Epilepsy
Completed
Conditions studied: Epilepsy
In brief
The purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.
Key facts
- Study ID
- NCT01202669
- Run by
- Cyberonics, Inc.
- People needed
- 98
- Starts
- 2010-08-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2014-08-07
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients enrolled in the study must meet all of the following criteria:
- Patient has a clinical diagnosis of epilepsy requiring evaluation in an epilepsy monitoring unit (EMU).
- Patient likely requires an EMU evaluation for a period of at least 24 hours.
- Patient is currently taking at least one antiepileptic medication.
- Patient must be in good general health and fully ambulatory.
- Patient or guardian must be willing and able to complete informed consent/assent and HIPAA authorization.
You may not qualify if…
- Patients who meet any of the following criteria are not eligible to be enrolled in the study:
- Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
- Patients with a history of status epilepticus.
- 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.
- 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.
- Patients with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.
Where it is running
- University of Florida — Gainesville, Florida, United States
- University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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