3-D Tractography Focused Ultrasound Ablation for Essential Tremor

3-D 纤维束成像聚焦超声消融治疗特发性震颤

基本信息

  • 批准号:
    10344274
  • 负责人:
  • 金额:
    $ 77.66万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-07-01 至 2027-05-31
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY Essential tremor (ET) is a common neurological disorder and a leading cause of functional and psychological disabilities that can be difficult to suppress with oral medications, many of which have considerable side effects limiting adequate dosing. As a result, up to 20% of ET patients cannot achieve satisfactory control of their symptoms and must consider interventional options. Focused ultrasound ablation (FUSA) of the ventral intermediate nucleus (Vim) is an FDA-approved and Medicare-reimbursed procedure for ET resistant to medications that can selectively ablate the brain area associated with tremor without the need for surgical incisions or anesthesia. The success of Vim-FUSA depends on the ability to accurately ablate 70% of the Vim volume without lesioning neighboring structures, a goal that is complicated by technical challenges in three critical phases of the procedure: planning (identifying the Vim location and extension); delivery (ablating the Vim volume with adequate accuracy); and monitoring (confirming Vim ablation with reliable intraoperative imaging). We propose to advance Vim-FUSA with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. We hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. We also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes. Aim 1. Estimate and characterize the improvement in Vim ablation achieved with 3-D tractography Vim-FUSA vs. standard Vim-FUSA in an experimental controlled animal study. Through an experimental animal study, we will characterize the Vim ablation delivered with 3-D tractography Vim-FUSA in one hemisphere (experimental group) vs. standard Vim-FUSA in the opposite hemisphere (control group). Aim 2. Test safety, feasibility, and preliminary efficacy, and estimate effect size of 3-D tractography Vim-FUSA in a phase-II, two-groups, pre-post interventional human study. In a human study, we will test the safety and feasibility of ablating 70% of the Vim volume while checking for side effects with intraoperative clinical testing. Tremor assessments will be videotaped at baseline and 12 weeks and compared, in a blinded fashion, with age-sex matched controls randomly selected from the video repository of the two FDA-regulated studies of standard Vim-FUSA at baseline and 12 weeks. Aim 3 (Exploratory). Assess the accuracy of i-MR in differentiating tissue ablation from immediate perilesional edema and its utility in predicting Vim-FUSA clinical outcomes. In the experimental animal study, we will estimate and compare the accuracy of conventional and non-conventional i-MR in differentiating tissue necrosis from perilesional edema. In the interventional human study, we will evaluate the utility of i-MR in predicting Vim-FUSA clinical outcomes.
项目摘要 特发性震颤(ET)是一种常见的神经系统疾病,是功能性和心理性震颤的主要原因。 口服药物难以抑制的残疾,其中许多药物具有相当大的副作用 限制了足够的剂量。结果,高达20%的ET患者不能达到令人满意的控制他们的 症状,必须考虑干预措施。腹部的聚焦超声消融(FUSA) 中间核(Vim)是一种FDA批准和Medicare报销的ET耐药程序, 可以选择性地消融与震颤相关的大脑区域而无需手术的药物 切口或麻醉。Vim-FUSA的成功取决于能否准确消融70%的Vim 体积而不损害邻近结构,这一目标因三个方面的技术挑战而变得复杂 手术的关键阶段:计划(确定Vim位置和延伸);输送(消融Vim 具有足够准确性的体积);和监测(通过可靠的术中成像确认Vim消融)。 我们建议在3-D纤维束成像的支持下推进Vim-FUSA,这是一种神经成像技术, 代表大脑中的神经束。我们假设3-D纤维束成像Vim-FUSA将改善Vim 与标准Vim-FUSA相比,消融术的安全性和可行性在临床环境中得到了证明。我们还假设 术中磁共振(i-MR)监测将区分消融组织和即刻消融组织, 病灶周围水肿,并准确预测Vim-FUSA的临床结果。 目标1。估计和表征使用3-D纤维束成像实现的Vim消融改善 实验对照动物研究中的Vim-FUSA与标准Vim-FUSA。通过实验 在动物研究中,我们将描述在一个半球中使用3-D纤维束成像Vim-FUSA进行的Vim消融的特征 (实验组)与对侧半球中的标准Vim-FUSA(对照组)。 目标2.测试3-D纤维束成像的安全性、可行性和初步疗效,并估计其效应量 Vim-FUSA在一项II期、两组、干预前后人体研究中的应用。在人类研究中,我们将测试 消融70%的Vim体积同时检查术中副作用的安全性和可行性 临床试验震颤评估将在基线和12周时进行录像,并进行比较, 时尚,年龄性别匹配的对照组随机选择的两个FDA监管的视频库, 在基线和12周时的标准Vim-FUSA研究。 目标3(探索性)。评估i-MR在区分组织消融和即刻消融方面的准确性 病灶周围水肿及其在预测Vim-FUSA临床结局中的效用。在实验动物中 研究中,我们将估计和比较传统和非传统i-MR在区分 病灶周围水肿导致的组织坏死。在介入性人体研究中,我们将评估i-MR在以下方面的效用: 预测Vim-FUSA临床结局。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
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Vibhor Krishna的其他文献

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