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

Cyberonics

Status

Completed

Conditions

Epilepsy

Treatments

Device: M106 VNS Therapy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01846741

Epilepsy (E)-37

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.