Clinical trial NCT01846741: VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
Official title: VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Automatic Magnet Mode (AMM)
Vagus Nerve Stimulation (VNS)
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-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.

Eligibility criteria: 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.

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.
timeFrame: Up to 18 Month Visit-End of Study
Secondary outcomes:
measure: Summary of Seizures Reported by Investigators and Triple Review
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Assess Characterization of Seizures (Duration and Cessation)
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes From Baseline in Seizure Frequency
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System
timeFrame: From initial titration visit (approximately 2 weeks after implantation) up to End of Study
measure: Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.
timeFrame: Up to 6 Month Visit
measure: Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.
timeFrame: Up to 18 Month Visit-End of Study
measure: Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician
timeFrame: Up to 18 Month Visit-End of Study
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Stanford
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Ann Arbor
country: United States
state: Michigan
city: St. Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Pittsburgh
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Cyberonics, Inc.
name: Jason Begnaud
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Robert Fisher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: