ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy
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.
- The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree"
- the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently"
- 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
- 否
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
Padraig O'Suilleabhain
Professor
University of Texas Southwestern Medical Center
