Seizure Detection and Automatic Magnet Mode Performance Study

NCT ID: NCT01325623

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-07-31

Brief 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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Model 106 VNS Therapy System

Model 106 VNS Therapy System includes a new Seizure Detection Algorithm (SDA) and corresponding Automatic Magnet Mode (AMM) feature.

Group Type: OTHER

Model 106 VNS Therapy System

Intervention Type: DEVICE

The VNS Therapy System is an adjunctive therapy for the treatment of epilepsy. VNS Therapy is available as a scheduled stimulation, this is cyclic stimulation between programmable On- and Off- times (e.g., a 30-second burst every 5 minutes). VNS Therapy is also available as on-demand stimulation, that is, when a magnet is introduced briefly over the implanted device (Magnet Mode). The AspireSR VNS Therapy System includes a new feature, Automatic Magnet Mode or AutoStim. In addition to Normal Mode and Magnet Mode, AspireSR uses a Seizure Detection Algorithm to identify a potential seizure onset based on associated heart rate increases known as ictal tachycardia. The purpose is to deliver stimulation at or near the onset of a seizure.

Interventions

Model 106 VNS Therapy System

The VNS Therapy System is an adjunctive therapy for the treatment of epilepsy. VNS Therapy is available as a scheduled stimulation, this is cyclic stimulation between programmable On- and Off- times (e.g., a 30-second burst every 5 minutes). VNS Therapy is also available as on-demand stimulation, that is, when a magnet is introduced briefly over the implanted device (Magnet Mode). The AspireSR VNS Therapy System includes a new feature, Automatic Magnet Mode or AutoStim. In addition to Normal Mode and Magnet Mode, AspireSR uses a Seizure Detection Algorithm to identify a potential seizure onset based on associated heart rate increases known as ictal tachycardia. The purpose is to deliver stimulation at or near the onset of a seizure.

Intervention Type: DEVICE

Other Intervention Names

AspireSR VNS Therapy System

Eligibility Criteria

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.
• Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
• Patients with a history of only psychogenic or pseudo seizures.
• Women who are pregnant. Women of childbearing age must take a pregnancy test.
• Patients currently enrolled in another investigational study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

Cyberonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryan Olin

Role: STUDY_DIRECTOR

Cyberonics, Inc.

Paul Boon

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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

Oslo University Hospital

Oslo, , Norway

King's College Hospital

London, , United Kingdom

The National Hospital for Neurology and Neurosurgery

London, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Belgium; Germany; Netherlands; Norway; United Kingdom

References

Boon P, Vonck K, van Rijckevorsel K, El Tahry R, Elger CE, Mullatti N, Schulze-Bonhage A, Wagner L, Diehl B, Hamer H, Reuber M, Kostov H, Legros B, Noachtar S, Weber YG, Coenen VA, Rooijakkers H, Schijns OE, Selway R, Van Roost D, Eggleston KS, Van Grunderbeek W, Jayewardene AK, McGuire RM. A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. Seizure. 2015 Nov;32:52-61. doi: 10.1016/j.seizure.2015.08.011. Epub 2015 Sep 21.

Reference Type: RESULT

PMID: 26552564 (View on PubMed)

Verrier RL, Nearing BD, Olin B, Boon P, Schachter SC. Baseline elevation and reduction in cardiac electrical instability assessed by quantitative T-wave alternans in patients with drug-resistant epilepsy treated with vagus nerve stimulation in the AspireSR E-36 trial. Epilepsy Behav. 2016 Sep;62:85-9. doi: 10.1016/j.yebeh.2016.06.016. Epub 2016 Jul 21.

Reference Type: DERIVED

PMID: 27450311 (View on PubMed)

Other Identifiers

Epilepsy (E)-36

Identifier Type: -

Identifier Source: org_study_id