Heart Rate Changes in Subjects With Epilepsy

NCT01202669 | Completed

• 1 other identifier: E-30
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Collection of physiologic data during an Epilepsy Monitoring Unit (EMU) stay

  To collect continuous observational video, electroencephalogram (EEG), electrooculogram (EOG), and electrocardiogram (ECG) data during ictal and non-ictal events occurring over a clinical EMU evaluation.

  up to 7 days

Study Arms (1)

Epilepsy patients, EMU stay

Other: No intervention planned, observational study only.

Interventions

No intervention planned, observational study only. OTHER

No intervention planned, observational study only.

Epilepsy patients, EMU stay

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Epilepsy patients indicated for epilepsy monitoring unit stay.

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.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (11)

• VAN BUREN JM. Some autonomic concomitants of ictal automatism; a study of temporal lobe attacks. Brain. 1958 Dec;81(4):505-28. doi: 10.1093/brain/81.4.505. No abstract available.

  PMID: 13618449 BACKGROUND

• Marshall DW, Westmoreland BF, Sharbrough FW. Ictal tachycardia during temporal lobe seizures. Mayo Clin Proc. 1983 Jul;58(7):443-6.

  PMID: 6865478 BACKGROUND

• Keilson MJ, Hauser WA, Magrill JP. Electrocardiographic changes during electrographic seizures. Arch Neurol. 1989 Nov;46(11):1169-70. doi: 10.1001/archneur.1989.00520470023018.

  PMID: 2818251 BACKGROUND

• Smith PE, Howell SJ, Owen L, Blumhardt LD. Profiles of instant heart rate during partial seizures. Electroencephalogr Clin Neurophysiol. 1989 Mar;72(3):207-17. doi: 10.1016/0013-4694(89)90245-9.

  PMID: 2465123 BACKGROUND

• Schernthaner C, Lindinger G, Potzelberger K, Zeiler K, Baumgartner C. Autonomic epilepsy--the influence of epileptic discharges on heart rate and rhythm. Wien Klin Wochenschr. 1999 May 21;111(10):392-401.

  PMID: 10413832 BACKGROUND

• Di Gennaro G, Quarato PP, Sebastiano F, Esposito V, Onorati P, Grammaldo LG, Meldolesi GN, Mascia A, Falco C, Scoppetta C, Eusebi F, Manfredi M, Cantore G. Ictal heart rate increase precedes EEG discharge in drug-resistant mesial temporal lobe seizures. Clin Neurophysiol. 2004 May;115(5):1169-77. doi: 10.1016/j.clinph.2003.12.016.

  PMID: 15066542 BACKGROUND

• Leutmezer F, Schernthaner C, Lurger S, Potzelberger K, Baumgartner C. Electrocardiographic changes at the onset of epileptic seizures. Epilepsia. 2003 Mar;44(3):348-54. doi: 10.1046/j.1528-1157.2003.34702.x.

  PMID: 12614390 BACKGROUND

• Novak V, Reeves AL, Novak P, Low PA, Sharbrough FW. Time-frequency mapping of R-R interval during complex partial seizures of temporal lobe origin. J Auton Nerv Syst. 1999 Sep 24;77(2-3):195-202.

  PMID: 10580303 BACKGROUND

• Epstein MA, Sperling MR, O'Connor MJ. Cardiac rhythm during temporal lobe seizures. Neurology. 1992 Jan;42(1):50-3. doi: 10.1212/wnl.42.1.50.

  PMID: 1734323 BACKGROUND

• Zijlmans M, Flanagan D, Gotman J. Heart rate changes and ECG abnormalities during epileptic seizures: prevalence and definition of an objective clinical sign. Epilepsia. 2002 Aug;43(8):847-54. doi: 10.1046/j.1528-1157.2002.37801.x.

  PMID: 12181003 BACKGROUND

• van Elmpt WJ, Nijsen TM, Griep PA, Arends JB. A model of heart rate changes to detect seizures in severe epilepsy. Seizure. 2006 Sep;15(6):366-75. doi: 10.1016/j.seizure.2006.03.005. Epub 2006 Jul 7.

  PMID: 16828317 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bryan Olin

  Employee

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: September 16, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

US (2)