NCT01846741已完成不适用
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 15
- 主要终点
- 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.
研究概览
简要总结
Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Up to 18 Month Visit-End of Study
The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.
次要结局
- Summary of Seizures Reported by Investigators and Triple Review(Epilepsy Monitoring Unit (EMU) Stay)
- Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed(Epilepsy Monitoring Unit (EMU) Stay)
- Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled(Epilepsy Monitoring Unit (EMU) Stay)
- Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods(Epilepsy Monitoring Unit (EMU) Stay)
- Assess Characterization of Seizures (Duration and Cessation)(Epilepsy Monitoring Unit (EMU) Stay)
- Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)(Up to 18 Month Visit-End of Study)
- Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)(Up to 18 Month Visit-End of Study)
- Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)(Up to 18 Month Visit-End of Study)
- Assess Changes From Baseline in Seizure Frequency(Up to 18 Month Visit-End of Study)
- Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline(Up to 18 Month Visit-End of Study)
- Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System(From initial titration visit (approximately 2 weeks after implantation) up to End of Study)
- Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.(Up to 6 Month Visit)
- Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.(Up to 18 Month Visit-End of Study)
- Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital(Up to 18 Month Visit-End of Study)
- Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work(Up to 18 Month Visit-End of Study)
- Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.(Up to 18 Month Visit-End of Study)
- Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician(Up to 18 Month Visit-End of Study)
研究者
研究点 (15)
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