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Seizure Detection and Automatic Magnet Mode Performance Study

NCT01325623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-01-22

Study results available
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Summary

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

Conditions

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.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Olin · Cyberonics, Inc.

  • Paul Boon · University Ghent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-07-31
Completion
2015-07-31

Countries

  • Belgium
  • Germany
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325623 on ClinicalTrials.gov