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临床试验/NCT01734122
NCT01734122招募中不适用

Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Tremor-related Quality of Life

研究概览

简要总结

The purpose of this study is to determine the changes in quality of life and degree of tremor for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description below for more information.

详细描述

Tremor is the most common of all movement disorders. Patients with essential tremor (ET) or Parkinsonian tremor (PT) may be severely disabled by their tremor. When the tremor is inadequately controlled by medications, surgical options are often offered. However, some patients may prefer a noninvasive treatment approach and some patients are not surgical candidates for medical reasons.

Stereotactic radiosurgery (SRS) is a treatment that uses high-energy highly-focused radiation (X-rays) to destroy a tiny region in the brain that causes tremor to occur. This region is known as the ventral intermedius nucleus of the thalamus and is the same area targeted by surgical deep brain stimulator (DBS) treatment or neurosurgical operation (thalamotomy). Multiple case series publications using Gamma Knife stereotactic radiation have been reported that show stereotactic radiosurgery is safe and effective treatment for ET and PT, making it a standard treatment for inoperable and inadequately controlled tremor patients. However, radiation treatment by linear accelerator machines are much more common than Gamma Knife treatment machines in the United States, and there are no reports of large series of ET and PT patients treated using linear accelerator-based SRS using a noninvasive mask-based targeting system.

This clinical trial asks the question of whether linear accelerator-based SRS is as safe and effective as that reported for Gamma Knife procedures, and whether it is a valid alternative to surgical thalamotomy or implantation of a deep brain stimulator (DBS) device. The primary measurements are quality of life related to tremor before and after stereotactic radiosurgery treatment, and secondary measurements are degree of tremor severity and usage of tremor-related medications.

Stereotactic Radiosurgery (SRS) is a standard-of-care treatment for patients with severe tremor. This clinical trial is a questionnaire-based trial that only involves completion of 2 questionnaires at the consultation appointments with neurology and radiation oncology. The questionnaires only take a few minutes and will provide us with valuable information about how severe the patient's tremor is before and after SRS treatment at 3-month intervals for 1 year. Currently we are only performing SRS treatment on one side of the brain (effects one side of the body) so the side with the worst tremor is treated.

Financial: All associated steps listed below are considered the Standard of Care to receive SRS treatment for tremor and are billed to the patient's insurance per the usual routine. Patients can receive this treatment without participating in the clinical trial questionnaires. There is no financial support, no compensation, and no travel stipend available to patients who participate in this trial.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Must be certified by a neurologist as having essential tremor or Parkinsonian tremor that is insufficiently controlled by medication alone.
  • Preference to receive radiation treatment for tremor treatment, rather than surgical DBS implantation or surgical thalamotomy
  • At least 18 years old

排除标准

  • Contraindications to cranial radiation (such as prior radiation to the thalamus)
  • Inability to have a MRI of the brain
  • Prior surgical thalamotomy treatment (but contralateral deep brain stimulator [DBS] is permitted)
  • Estimated life expectancy less than 1 year

研究组 & 干预措施

Essential Tremor

Patients with severe, medication-refractory Essential Tremor

干预措施: Questionnaires / Observational Assessments (Other)

Parkinsonian Tremor

Patients with severe, medication-refractory, tremor-dominant Parkinsons

干预措施: Questionnaires / Observational Assessments (Other)

结局指标

主要结局

Tremor-related Quality of Life

时间窗: 1 year

The tremor-related quality of life for each patient will be assessed by self-assessment questionnaire at 3 month intervals for 1 year after treatment by stereotactic radiation.

次要结局

  • Neuropsychological Assessment(Baseline and 6 months post-treatment)
  • Severity of Tremor(1 year)

研究者

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

Austin Kirschner

Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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