NCT04112381进行中（未招募）不适用
A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- InSightec
- 入组人数
- 51
- 试验地点
- 14
- 主要终点
- Device and procedure related adverse events
研究概览
简要总结
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 22 years or older
- •Diagnosis of medication-refractory Essential Tremor
- •Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
- •Able to communicate sensations during the Exablate thalamotomy procedure
排除标准
- •Has experienced any non-transient neurological event or worsening following the Exablate index procedure
- •Presence of unknown or MR unsafe devices anywhere in the body
- •Non-transient hemiparesis as determined by physical examination
- •Clinically significant abnormal speech function as determined by a speech pathologist
- •Pregnant or breastfeeding
- •Unstable cardiac status
- •Behavior(s) consistent with ethanol or substance abuse
- •History of bleeding disorder
- •Has received anticoagulants within one month of Exablate procedure
- •Cerebrovascular disease
- •Intracranial tumor
- •Active or suspected acute or chronic uncontrolled infection
- •Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
- •Implanted objects in the skull or the brain
- •Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
- •Unable to communicate with the investigator and staff
结局指标
主要结局
Device and procedure related adverse events
时间窗: 3 months
rate of adverse events following the Exablate secondary procedure
次要结局
未报告次要终点
研究者
研究点 (14)
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