Trial Search Results
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
Stanford is currently accepting patients for this trial.
- Device: M106 VNS Therapy System
- 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.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study