convulsion epilepsy
Conditions
Interventions
None listed
Sponsors
Cyberonics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System. 2. 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. 3. Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time. 4. Patients having an average of * 6 seizures per month based upon diary or patient reporting for the 3 months prior to enrolling. 5. Patients must have peak-peak R-wave amplitude greater than or equal to 0.25 mV on ECG measured from the proposed electrode location in the neck to the proposed generator location in the chest via surface ECG electrodes. 6. Patients must be at least 18 years old. 7. Patients must be in good general health and ambulatory. 8. Patient or guardian must be willing and able to complete informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients have had a bilateral or left cervical vagotomy. 2. Patients currently use, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. 3. A VNS Therapy System implant would (in the investigator*s judgment) pose an unacceptable surgical or medical risk for the patient. 4. Patients expected to require full body magnetic resonance imaging. 5. Patients have a history of VNS Therapy. 6. Patients have a documented history of clinically meaningful bradycardia (heart rate less than 50 bpm) associated with seizures. 7. Patients with a significant psychiatric disorder, history of 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. 8. Patients with a history of status epilepticus within 3 months of study enrollment. 9. 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*). 10. 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. 11. Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years. 12. Patients with a history of only psychogenic or pseudo seizures. 13. Women who are pregnant. Women of childbearing age must take a pregnancy test. 14. Patients currently enrolled in another investigational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The purpose of this study is to confirm R-wave detection and to determine whether the SDA and AMM perform in vivo as predicted in silico (i.e. software performance tested by using a library of vEEG/ECG data from multiple patients). Performance analyses are conducted as described below. Primary Performance Objective Sensitivity and potential false positive rate per hour * Using vEEG and ECG recordings from the EMU stay, sensitivity and potential false positive rate per hour will be estimated to confirm the performance of the algorithm*s ability to detect seizures at different SDA settings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Performance Objectives 1. R-Wave ECG Detection * During the implant procedure, patient heart rates will be calculated using detected R-waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre-specified time interval. R-wave detection will also be evaluated postoperatively when the patient awakens, at each titration visit, at the beginning and end of the EMU stay, and at the 12 month visit. 2. Latency * Difference between the time of seizure onset and the time of seizure detection by the IPG based on vEEG and ECG recordings collected during the EMU stay and adjudicated by qualified personnel such as neurologists. 3. Post-Stimulation Heart Rate Changes * Heart rate changes during and after stimulation. 4. Seizure Frequency * Baseline measurements of seizure frequency will be collected and compared to patient diary data collected at specific time points post-baseline. 5. Seizure Severity * Baseline measurements of patient and physician rated seizure severity will be collected at baseline and compared to patient rated seizure severity at specific time point*s post-baseline. 6. Seizure Duration and Intensity * Pre-study EEG/ECG recordings will be collected from study patients and used for comparison of seizure duration and intensity during similar recordings during the study EMU stay. 7. Post-Ictal Duration * Pre-study EEG/ECG recordings will be collected from study patients and used for comparison of post-ictal during similar recordings during the study EMU stay. 8. Quality of Life * Baseline measurements of patient rated quality of life will be collected at baseline and compared to patient rated quality of life at specific time points post-baseline. | — |
Countries
Netherlands
Outcome results
None listed