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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214707
• Other study ID #: E-31
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2010
• Last updated: March 13, 2012
• Start date: September 2010

Study information

• Verified date: March 2012
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Exercise
Exercise during EMU stay

Locations

Country	Name	City	State
United States	KUMC	Kansas City	Kansas
United States	BNI	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No