N/A N=31 Treatment

Seizure Detection and Automatic Magnet Mode Performance Study

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT01325623 ↗

Enrolled (actual)

Serious AEs

32.3%

Results posted

Jan 2016

Primary outcome: Primary: Summary of Seizures Reported by Investigators and Triple Review — 87; 124; 211; 82 Seizures

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Model 106 VNS Therapy System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cyberonics, Inc.
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary of Seizures Reported by Investigators and Triple Review	87; 124; 211; 82; 51; 133	—
PRIMARY Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting	100; 75; 100; 66.7; 100; 50	—
PRIMARY Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant	100; 85.7; 81.8; 89.5; 88.9; 92.5	—
PRIMARY Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting	0.5; 2.7; 7.2	—
SECONDARY Validation of Cardiac R-Wave Detection	95.52; 98.74; 99.71; 99.43	—
SECONDARY Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting	4; 19.5; 27.5; 27.5; -14.5; 7	—
SECONDARY Human Factors and Usability of the AspireSR® VNS Therapy® System.	76.2; 73.9; 61.1; 70.0; 75.0; 81.0	—
SECONDARY Changes From Baseline in Seizure Frequency	24.1; 25.9; 20.0; 25; 33.3; 36.0	—
SECONDARY Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)	0.00; -1.00; 0.00; -4.00; 0.00; -1.00	0.375
SECONDARY Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)	0.516; 0.728; 0.354; 0.341; 0.966; 1.115	0.1529
SECONDARY Proportion of Seizures Ending During Stimulation by Type	57.6; 20; 100; 54.5; 0.0; 66.7	—
SECONDARY Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)	45.5; 40.5; NA; 150.2; 26.8; 150.7	—
SECONDARY Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)	274.6; 102.8; NA; 44.1; 85.7; 66.6	—
SECONDARY Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)	3.7; 4.4; 8.9; 10.2; 8.7; 2.3	0.2079
SECONDARY Overall Summary of Seizure Intensity by Subgroup	33.9; 225.3; 406.6; NA; 205.4; 989.4	—
SECONDARY Post-stimulation Heart Rate Changes	0.74; 0.09; -0.01	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01325623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.