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

NCT01846741

NOT RECRUITING

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

VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia

Ages Eligible for Study: Older than 12 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

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.

Stanford Department of Neurology
(650) 498-7551

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