VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01846741
First received: April 15, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator


Condition Intervention
Epilepsy
Device: M106 VNS Therapy System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Estimate the effect size associated with objective measures and patient self-reports of clinical outcomes including seizure frequency, seizure severity, seizure duration, seizure intensity, and post-ictal duration [ Time Frame: Up to 26 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess performance of the cardiac-based seizure detection and Automatic Magnet Mode (AMM) of the Model 106 device during an EMU stay. [ Time Frame: Up to 26 months ] [ Designated as safety issue: No ]
  • Assess performance of the cardiac-based seizure detection and Automatic Magnet Mode (AMM) of the Model 106 device during an EMU stay during known periods of exercise. [ Time Frame: Up to 26 months ] [ Designated as safety issue: No ]
  • Assess treatment emergent adverse events 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 ]
  • Assess changes in Anti-Epileptic Drug (AED) drug load. [ Time Frame: Up to 26 months ] [ Designated as safety issue: No ]
  • Assess changes in healthcare utilization. [ Time Frame: Up to 26 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Prospective, observational, un-blinded, 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, and 6-month follow-up. After the 6-month follow-up, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

12 Years and older

Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of medically refractory epilepsy with partial onset seizures suitable for implantation with the 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 12 years old.
  • Patients must be in good general health and ambulatory.
  • Patient or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria:

  • Patients have had a bilateral or left cervical vagotomy.
  • Patients currently using, 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 (MRI).
  • Patients have a history of implantation of the VNS Therapy.
  • Patients with an IQ known or estimated to be < 70, history of depression requiring hospitalization, 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 epilepticus within 1 year 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 during the baseline period.
  • Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
  • Patients with a history of psychogenic non-epileptic seizures.
  • Women who are pregnant. Women of childbearing age must take a pregnancy test and agree to use an approved method of contraception during the study.
  • Patients currently enrolled in another investigational study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846741

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Stanford, California, United States
United States, Florida
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
St. Paul, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New York
Albany, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Bryan Olin, PhD Cyberonics, Inc.
Principal Investigator: Robert Fisher, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01846741     History of Changes
Other Study ID Numbers: Epilepsy (E)-37
Study First Received: April 15, 2013
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Epilepsy
Tachycardia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014