SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 157
- 主要终点
- Primary Analysis: Change in Seizure Rate
研究概览
简要总结
The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications.
详细描述
Medtronic, Inc. is sponsoring an investigational study of the Medtronic DBS Therapy for epilepsy, the company's deep brain stimulation (DBS) therapy for patients with refractory epilepsy. Epilepsy is a condition that affects 2.3 million Americans, and about one-third of these patients are refractory, or continue to experience seizures despite a wide range of treatment options.
The prospective, randomized, double-blind trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy. It includes enrollment of 157 patients at 17 sites in the U.S. 110 patients were implanted and monitored for 13 months following implant, with long-term follow-up until the device is approved or the study is stopped. 109 of the 110 implanted subjects were randomized to Active stimulation or Control.
Patients in the active group, who received neurostimulation, were monitored for a reduction in seizure rates compared to the control group, who did not receive neurostimulation during the three-month double-blind phase. After the double-blind phase, all patients received neurostimulation.
Candidates for the trial were adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. They were to have had an average of six or more seizures per month. Candidates continued to receive their epilepsy medications while participating in the trial.
Deep brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Deep brain stimulation is not approved in the United States for the treatment of epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Multilobar (>3 different lobes) anatomic areas of seizure onset
- •Symptomatic generalized epilepsy
- •Previous diagnosis of psychogenic/non-epileptic seizures
- •Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed if the device has been turned off for at least 30 days prior to the Baseline Week -12 visit and the patient agrees to have the generator explanted prior to or at the time of the Kinetra Neurostimulator implant.
研究组 & 干预措施
1
Active Stimulation
干预措施: Medtronic DBS Therapy for epilepsy (Device)
2
No Stimulation
干预措施: Medtronic DBS Therapy for epilepsy (Device)
结局指标
主要结局
Primary Analysis: Change in Seizure Rate
时间窗: Through the end of the three-month blinded phase
A protocol-prespecified generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. The final GEE model for the primary objective evaluation included treatment effect, log of the baseline seizure count, log of age, visit (categorical), treatment-by-visit interaction (categorical), and the offset (the number of days the diary was recorded in each month).
Alternative Primary Analysis: Change in Seizure Rate
时间窗: Through the end of the three-month blinded phase
A generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. With one outlier subject removed, the GEE model for this alternative analysis included treatment effect, log of the baseline seizure count, log of age, visit (categorical), and the offset (the number of days the diary was recorded in each month).
次要结局
- Adverse Events Experienced With the Medtronic DBS System(Through Year 2 of the long-term follow-up phase)
- Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)(Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years))
- Seizure Responder Rate(Through the end of the three-month blinded phase)
- Change in Percentage of Days Seizure-free(Through the end of the three-month blinded phase)
- Percentage Change in the Maximum Length of Seizure-free Intervals(Through the end of the three-month blinded phase)
- Proportion of Treatment Failures(Through the end of the three-month blinded phase)