Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment m106 vns therapy system
Sponsor Cyberonics, Inc.
Start date July 2013
End date August 2014
Trial size 20 participants
Trial identifier NCT01846741, Epilepsy (E)-37

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
m106 vns therapy system

Primary Outcomes

Measure
Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration.
time frame: Up to 12 Month Visit

Secondary Outcomes

Measure
Summary of Seizures Reported by Investigators and Triple Review
time frame: Epilepsy Monitoring Unit (EMU) Stay
Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed
time frame: Epilepsy Monitoring Unit (EMU) Stay
Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled
time frame: Epilepsy Monitoring Unit (EMU) Stay
Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods
time frame: Epilepsy Monitoring Unit (EMU) Stay
Assess Characterization of Seizures (Duration and Cessation)
time frame: Epilepsy Monitoring Unit (EMU) Stay
Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)
time frame: Up to 12 Month Visit
Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)
time frame: Up to 12 Month Visit
Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)
time frame: Up to 12 Month Visit
Assess Changes From Baseline in Seizure Frequency
time frame: Up to 12 Month Visit
Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline
time frame: Up to 12 Month Visit
Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System
time frame: From initial titration visit (approximately 2 weeks after implantation) up to 12 Month Visit
Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.
time frame: Up to 6 Month Visit
Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.
time frame: Up to 12 Month Visit
Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital
time frame: Up to 12 Month Visit
Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work
time frame: Up to 12 Month Visit
Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.
time frame: Up to 12 Month Visit
Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician
time frame: Up to 12 Month Visit

Eligibility Criteria

Male or female participants at least 12 years old.

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.

Additional Information

Official title VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia
Principal investigator Robert Fisher, MD, PhD
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-month follow-up. After the 6-month follow-up, 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 July 2015.
Information provided to ClinicalTrials.gov by Cyberonics, Inc..