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OpenTrials
Completed

NCT Number: NCT01214707

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BNI, Phoenix, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exercise

Other

Exercise during EMU stay

Other names: Exercise during EMU stay. No treatment intervention.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cyberonics, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
First posted
Oct 5, 2010
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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