31
Participants
Start Date
March 31, 2011
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2015
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.
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
Lead Sponsor
Collaborators (1)
PRA Health Sciences
INDUSTRY
Cyberonics, Inc.
INDUSTRY