Seizure Detection and Automatic Magnet Mode Performance Study

NACompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2015

Conditions
Epilepsy
Interventions
DEVICE

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.

Trial Locations (14)

Unknown

Hôpital Erasme, Anderlecht

Cliniques Universitaires Saint-Luc, Brussels

Universitair Ziekenhuis Gent, Ghent

Epilepsie-Zentrum Bethel, Bielefeld

Universitätsklinikum Bonn, Bonn

Universitätsklinikum Erlangen, Erlangen

Albert-Ludwigs-Universität, Freiburg im Breisgau

Ludwig-Maximilians-Universität München, Munich

Universitätsklinikum Tübingen, Tübingen

Kempenhaege, Heeze

Oslo University Hospital, Oslo

King's College Hospital, London

The National Hospital for Neurology and Neurosurgery, London

Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

Cyberonics, Inc.

INDUSTRY

NCT01325623 - Seizure Detection and Automatic Magnet Mode Performance Study | Biotech Hunter | Biotech Hunter