Seizure Detection and Automatic Magnet Mode Performance Study (E-36)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01325623
First received: March 23, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Seizure Detection and Automatic Magnet Mode Performance Study

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 35
Study Start Date: March 2011
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Epileptics

Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System.
  • Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
  • Patients must be at least 18 years old.
  • Patients must be in good general health and ambulatory.
  • Patient or guardian must be willing and able to complete informed consent.

Exclusion Criteria:

  • Patients have had a bilateral or left cervical vagotomy.
  • Patients currently use, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
  • A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
  • Patients expected to require full body magnetic resonance imaging.
  • Patients have a history of VNS Therapy.
  • Patients with a significant psychiatric disorder, significant cognitive impairment, history of major depression, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
  • Patients with a history of status epileptic within 3 months of study enrollment.
  • Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained at the baseline visit.
  • Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
  • Patients with a history of only psychogenic or pseudo seizures.
  • Women who are pregnant. Women of childbearing age must take a pregnancy test.
  • Patients currently enrolled in another investigational study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325623

Locations
Belgium
Anderlecht, Belgium
Brussels, Belgium
Ghent, Belgium
Germany
Bielefeld, Germany
Bonn, Germany
Erlangen, Germany
Freiburg, Germany
Munich, Germany
Tübingen, Germany
Netherlands
Heeze, Netherlands
Norway
Oslo, Norway
United Kingdom
London, United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Cyberonics, Inc.
PRA International
Investigators
Study Director: Bryan Olin Cyberonics, Inc.
Principal Investigator: Paul Boon Universitair Ziekenhuis Gent
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01325623     History of Changes
Other Study ID Numbers: Epilepsy (E)-36
Study First Received: March 23, 2011
Last Updated: December 12, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cyberonics, Inc.:
Automatic Magnet Mode (AMM)
Vagal Nerve Stimulation

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014