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临床试验/NCT07430761
NCT07430761招募中不适用

ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
220
试验地点
1
主要终点
ET stigma psychological distress

研究概览

简要总结

Essential Tremor (ET) is prevalent, affecting approximately 3% of the adult population. Involuntary shaking of the hands during action is a prominent feature, interfering with feeding and writing and other manual tasks. The involuntary movement is visible to observers, some of whom misinterpret the shakiness as manifestation of anxiety or instability, while some other observers attribute it to alcohol or drug use. The psychological effects of resulting stigma on quality of life for people with ET can rival the physical difficulties caused by the condition.

For this study, we propose to measure 1 year after effective tremor suppression following thalamotomy with high intensity focused ultrasound changes from baseline in psychological distress and social dysfunction related to ET stigma, and to correlate change from baseline with improvement in functional status related to tremor and in objective measures of tremor severity. We hope to discover that ET stigma is largely reversible when tremor is effectively treated, and we aim to learn what degree of tremor suppression correlates with substantial psychological relief. We will also determine if ET stigma is predominantly helped by unilateral dominant-hand treatment, or if the second side treatment is necessary to accomplish most benefit.

详细描述

Study procedures:

Subjects will complete the following three surveys on two occasions i.e. at baseline, hours or days before thalamotomy, and again 12 months after the procedure (with a window of 11 to 18 months). Completing the three surveys takes approximately 5 minutes.

  1. The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree"
  2. the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently"
  3. the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with ET as diagnosed by a movement disorder neurologist
  • Tremor of sufficient severity and impact on quality of life so as to justify a lesional brain procedure
  • Competent to consent to undergoing high intensity focused ultrasound thalamotomy targeted by 4-tract tractography
  • Provide verbal informed consent to this study of ET stigma

排除标准

  • Patient declines to participate in this observational study

研究组 & 干预措施

ET for thalamotomy

Patients with diagnosis of problematic essential tremor refractory to pharmacologic treatment who are to undergo stereotactic thalamotomy with high intensity focused ultrasound.

干预措施: stereotactic thalamotomy with focused ultrasound (Procedure)

结局指标

主要结局

ET stigma psychological distress

时间窗: change from baseline before thalamotomy to 12 months after thalamotomy

Psychological distress related to other people's reaction to their tremor.

ET stigma social dysfunction

时间窗: change from baseline before thalamotomy to 12 months after thalamotomy

Social avoidance and maladaptive behaviors related to other people's reaction to tremor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Padraig O'Suilleabhain

Professor

University of Texas Southwestern Medical Center

研究点 (1)

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