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ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

2020年9月17日 更新者：InSightec

A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.

This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure.

Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.

研究类型

介入性

注册 (实际的)

27

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia
    • Washington
      • Seattle、Washington、美国、98122
        • Swedish Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Men and women, age 30 years and older
  • Subjects who are able and willing to give informed consent and able to attend all study visits
  • Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
  • Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
  • Subject exhibits a significant disability from their PD tremor despite medical treatment
  • Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
  • Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria:

  • Subjects with unstable cardiac status
  • Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
  • Severe hypertension
  • Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  • Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
  • Significant claustrophobia that cannot be managed with mild medication
  • Current medical condition resulting in abnormal bleeding and/or coagulopathy
  • Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
  • History of intracranial hemorrhage
  • History of multiple strokes, or a stroke within past 6 months
  • Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
  • Are participating or have participated in another clinical trial in the last 30 days
  • Subjects unable to communicate with the investigator and staff
  • Subjects with a history of seizures within the past year
  • Subjects with brain tumors
  • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
  • Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：ExAblate Transcranial MRgFUS
ExAblate Transcranial MR guided Focused Ultrasound
设备：ExAblate Transcranial MRgFUS
ExAblate Transcranial MR Guided Focused Ultrasound
其他名称：
  • 消融
  • 聚焦超声
  • 核磁共振
  • Transcranial MRgFUS Thalamotomy
假比较器：Sham ExAblate Transcranial MRgFUS
Sham treatment with ExAblate MR guided Focused Ultrasound
设备：Sham ExAblate Transcranial MRgFUS
Sham ExAblate Transcranial MR Guided Focused Ultrasound

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Adverse Events
大体时间：Month 3

Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment.

Primary safety analyses are reported in the adverse events module.
Month 3

次要结果测量

结果测量
措施说明
大体时间
Tremor Motor Score Percent Change From Baseline.
大体时间：Baseline, Month 3
The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).
Baseline, Month 3
Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.
大体时间：Baseline, Month 3, Month 12
Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.
Baseline, Month 3, Month 12
Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities
大体时间：Baseline, Month 3, Month 12
The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.
Baseline, Month 3, Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

InSightec

调查人员

  • 首席研究员：Jeff Elias, M.D.、University of Virginia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年9月1日

初级完成 (实际的)

2016年4月26日

研究完成 (实际的)

2019年3月1日

研究注册日期

首次提交

2012年11月28日

首先提交符合 QC 标准的

2013年1月18日

首次发布 (估计)

2013年1月21日

研究记录更新

最后更新发布 (实际的)

2020年10月9日

上次提交的符合 QC 标准的更新

2020年9月17日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PD001

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