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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
98 participants
OBSERVATIONAL
2010-08-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy
NCT01202682
Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy
NCT01214707
3-Dimensional Accelerometer Sub-Study
NCT01612689
Cardiac MRI for Detection of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
NCT05041296
Monitoring Patients With Uncontrolled Epilepsy
NCT00001149
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Epilepsy patients, EMU stay
No intervention planned, observational study only.
No intervention planned, observational study only.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention planned, observational study only.
No intervention planned, observational study only.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patient has a clinical diagnosis of epilepsy requiring evaluation in an epilepsy monitoring unit (EMU).
2. Patient likely requires an EMU evaluation for a period of at least 24 hours.
3. Patient is currently taking at least one antiepileptic medication.
4. Patient must be in good general health and fully ambulatory.
5. Patient or guardian must be willing and able to complete informed consent/assent and HIPAA authorization.
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 with a history of status epilepticus.
3. 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.
4. 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.
5. Patients with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cyberonics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bryan Olin
Role: STUDY_DIRECTOR
Employee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Florida
Gainesville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Marshall DW, Westmoreland BF, Sharbrough FW. Ictal tachycardia during temporal lobe seizures. Mayo Clin Proc. 1983 Jul;58(7):443-6.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E-30
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.