Status:
COMPLETED
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
Lead Sponsor:
Cyberonics, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
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-mon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01846741
Start Date
July 1 2013
End Date
August 1 2015
Last Update
November 24 2015
Active Locations (15)
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1
Phoenix, Arizona, United States
2
Stanford, California, United States
3
Tampa, Florida, United States
4
Atlanta, Georgia, United States