Seizure Detection and Automatic Magnet Mode Performance Study (E-36)
The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Seizure Detection and Automatic Magnet Mode Performance Study|
- Seizure Detection Performance evaluation of the Model 106 VNS Therapy® System [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]The primary study objective is to evaluate the Model 106 VNS Therapy® System cardiac-based seizure detection and Automatic Magnet Mode (AMM) stimulation in epilepsy patients.
- Assess stimulation-related adverse event rates to outline the tolerability profile of Model 106 device. [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
- Evaluation of human factors and usability of the system. [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
- Assess Characterization of Seizures [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
- Assess changes from baseline in quality of life [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||July 2015|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
|London, United Kingdom|
|Sheffield, United Kingdom|
|Study Director:||Bryan Olin||Cyberonics, Inc.|
|Principal Investigator:||Paul Boon||Universitair Ziekenhuis Gent|