Clinical trial NCT01325623: Seizure Detection and Automatic Magnet Mode Performance Study
Official title: Seizure Detection and Automatic Magnet Mode Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Automatic Magnet Mode (AMM)
Vagal Nerve Stimulation
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2011-03-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 with a history of increased heart rate (tachycardia) associated with seizure onset based on clinical data obtained from medical history, admission/hospital charts, or prior neurophysiologic evaluations.
* 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 having an average of ≥ 3 seizures per month based upon diary or patient reporting for the 3 months prior to the screening visit.
* Patients must have peak-peak R-wave amplitude greater than or equal to 0.40 mV on ECG measured from the proposed electrode location in the neck to the proposed generator location in the chest via surface ECG electrodes in 7 different body positions.
* Patients must be at least 18 years old.
* Patients must be in good general health and ambulatory.
* Patient 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 have a documented history of clinically meaningful bradycardia (heart rate less than 50 bpm) associated with seizures.
* 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 epilepticus within 3 months of study enrollment.
* Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers").
* 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 screening 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.

Primary outcomes:
measure: Summary of Seizures Reported by Investigators and Triple Review
timeFrame: Epilepsy Monitoring Unit Stay
measure: Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
Secondary outcomes:
measure: Validation of Cardiac R-Wave Detection
timeFrame: At Implant, First Titration Visit, Day 1 EMU and 12 Months
measure: Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Human Factors and Usability of the AspireSR® VNS Therapy® System.
timeFrame: At implant/recovery up to EMU Discharge (2 to 4 weeks)
measure: Changes From Baseline in Seizure Frequency
timeFrame: Up to 24 Month visit
measure: Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)
timeFrame: up to 24 Months Visit
measure: Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)
timeFrame: Up to 24 Month visit
measure: Proportion of Seizures Ending During Stimulation by Type
timeFrame: Epilepsy Monitoring Unit (EMU) Stay
measure: Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)
timeFrame: Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay
measure: Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)
timeFrame: Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay
measure: Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)
timeFrame: up to 24 Months Visit
measure: Overall Summary of Seizure Intensity by Subgroup
timeFrame: Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay
measure: Post-stimulation Heart Rate Changes
timeFrame: EMU stay
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Hôpital Erasme
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Bielefeld
country: Germany
facility: Epilepsie-Zentrum Bethel
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universität
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität München
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Heeze
country: Netherlands
facility: Kempenhaege
city: Oslo
country: Norway
facility: Oslo University Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Cyberonics, Inc.
name: Bryan Olin
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Gent
name: Paul Boon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boon P, Vonck K, van Rijckevorsel K, El Tahry R, Elger CE, Mullatti N, Schulze-Bonhage A, Wagner L, Diehl B, Hamer H, Reuber M, Kostov H, Legros B, Noachtar S, Weber YG, Coenen VA, Rooijakkers H, Schijns OE, Selway R, Van Roost D, Eggleston KS, Van Grunderbeek W, Jayewardene AK, McGuire RM. A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. Seizure. 2015 Nov;32:52-61. doi: 10.1016/j.seizure.2015.08.011. Epub 2015 Sep 21.
citation: Verrier RL, Nearing BD, Olin B, Boon P, Schachter SC. Baseline elevation and reduction in cardiac electrical instability assessed by quantitative T-wave alternans in patients with drug-resistant epilepsy treated with vagus nerve stimulation in the AspireSR E-36 trial. Epilepsy Behav. 2016 Sep;62:85-9. doi: 10.1016/j.yebeh.2016.06.016. Epub 2016 Jul 21.