VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
Trial ID or NCT#
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
- - 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.
- - 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.
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Stanford Department Of Neurology