This trial is active, not recruiting.

Condition epilepsy
Sponsor Cyberonics, Inc.
Collaborator PRA Health Sciences
Start date March 2011
End date July 2013
Trial size 35 participants
Trial identifier NCT01325623, Epilepsy (E)-36


The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Seizure Detection Performance evaluation of the Model 106 VNS Therapy® System
time frame: up to 26 months

Secondary Outcomes

Assess stimulation-related adverse event rates to outline the tolerability profile of Model 106 device.
time frame: up to 26 months
Evaluation of human factors and usability of the system.
time frame: up to 26 months
Assess Characterization of Seizures
time frame: up to 26 months
Assess changes from baseline in quality of life
time frame: up to 26 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 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 18 years old. - Patients must be in good general health and ambulatory. - Patient or guardian must be willing and able to complete informed consent. Exclusion Criteria: - Patients have had a bilateral or left cervical vagotomy. - Patients currently use, 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. - Patients have a history of VNS Therapy. - Patients with a significant psychiatric disorder, significant cognitive impairment, history of major depression, 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 epileptic within 3 months 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 at the baseline visit. - Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years. - Patients with a history of only psychogenic or pseudo seizures. - Women who are pregnant. Women of childbearing age must take a pregnancy test. - Patients currently enrolled in another investigational study.

Additional Information

Official title Seizure Detection and Automatic Magnet Mode Performance Study
Principal investigator Paul Boon
Description Prospective, observational, unblinded, 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. After the EMU stay, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Cyberonics, Inc..