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Seizure Detection and Automatic Magnet Mode Performance Study | Clinical Trials | Clareo Health

COMPLETEDNA

Seizure Detection and Automatic Magnet Mode Performance Study

NCT01325623•Cyberonics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.

Detailed Description

Prospective, observational, unblinded, multi-site study designed to collect data on patients implanted with a Model 106 VNS Therapy System from baseline through an EMU stay of up to 5 days. After the EMU stay, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System.
•Patients with a history of increased heart rate (tachycardia) associated with seizure onset based on clinical data obtained from medical history, admission/hospital charts, or prior neurophysiologic evaluations.
•Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
•Patients having an average of ≥ 3 seizures per month based upon diary or patient reporting for the 3 months prior to the screening visit.
•Patients must have peak-peak R-wave amplitude greater than or equal to 0.40 mV on ECG measured from the proposed electrode location in the neck to the proposed generator location in the chest via surface ECG electrodes in 7 different body positions.
•Patients must be at least 18 years old.
•Patients must be in good general health and ambulatory.
•Patient must be willing and able to complete informed consent.

Exclusion Criteria

•Patients have had a bilateral or left cervical vagotomy.
•Patients currently use, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
•A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
•Patients expected to require full body magnetic resonance imaging.
•Patients have a history of VNS Therapy.
•Patients have a documented history of clinically meaningful bradycardia (heart rate less than 50 bpm) associated with seizures.
•Patients with a significant psychiatric disorder, significant cognitive impairment, history of major depression, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
•Patients with a history of status epilepticus within 3 months of study enrollment.
•Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers").
•Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained at the screening visit.
+4 more criteria

Locations (14)

Hôpital Erasme

Anderlecht, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Epilepsie-Zentrum Bethel

Bielefeld, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Albert-Ludwigs-Universität

Freiburg im Breisgau, Germany

Ludwig-Maximilians-Universität München

Munich, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Kempenhaege

Heeze, Netherlands

Key Dates

Start Date

March 1, 2011

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2015

Last Updated

January 22, 2016

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Model 106 VNS Therapy System

DEVICE

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

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RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

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RECRUITINGNA

Intracranial Investigation of Neural Circuity Underlying Human Mood

NCT05871372

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Seizure Detection and Automatic Magnet Mode Performance Study

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers