CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Model 106 VNS Therapy Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01325623
NCT01325623N/ACompleted
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Seizure Detection and Automatic Magnet Mode Performance Study

Cyberonics, Inc.·interventional·Posted Mar 30, 2011·Updated Jan 22, 2016

In Brief

A clinical study evaluating Model 106 VNS Therapy System for Epilepsy. Completed, enrolled 31 participants across 14 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Germany, Netherlands, Norway, United Kingdom
CollaboratorsPRA Health Sciences

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.3 years ago

Interventions

Model 106 VNS Therapy Systemdevice

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.