N/A N=22 Treatment

VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT01846741 ↗

Enrolled (actual)

Serious AEs

15.0%

Results posted

Jul 2015

Primary outcome: Primary: 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.

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: M106 VNS Therapy System (Device)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Cyberonics, Inc.
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	—	—
SECONDARY Summary of Seizures Reported by Investigators and Triple Review	84; 5; 89; 76; 0; 76	—
SECONDARY Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed	0; 100; 100; 50	—
SECONDARY Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled	87.5; 100; 95; 100; 100; 100	—
SECONDARY Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods	0.4; 1.6; 0.8; 4.0; 1.2; 6.2	—
SECONDARY Assess Characterization of Seizures (Duration and Cessation)	61.3; 41.7; 0; 83.3; 75.0; 50.0	—
SECONDARY Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)	-2.0; -3.5; 0.0; -0.5; -1.0; 0.0	0.008 sig
SECONDARY Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)	1.349; 1.442; 1.469; 1.711; 1.567; 1.294	0.0008 sig
SECONDARY Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)	11.0; 11.8; 13.3; 14.4; 2.7; 4.0	0.0192 sig
SECONDARY Assess Changes From Baseline in Seizure Frequency	25; 20; 35; 35; 50; 50	—
SECONDARY Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline	0; 0; 3.35; 0	0.0625
SECONDARY Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System	6; 6; 3; 3; 2; 2	—
SECONDARY Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.	89; 83; 95; 100	—
SECONDARY Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.	0; 0; 0; 0; 0; 0	—
SECONDARY Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital	0; 0; 0; 0	—
SECONDARY Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work	0; 0; 0; 0; 0; 0	—
SECONDARY Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.	2.0; 1.0; 4.0; 2.0	—
SECONDARY Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician	0; 0; 0; 0	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01846741). 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.