Gamma Knife Thalamotomy for Treatment of Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
研究概览
简要总结
The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.
详细描述
This research is being done because although multiple studies evaluating gamma knife for essential tremor show good results, few studies evaluating patients prospectively have been done. Prior studies have looked at patient outcomes following treatment - also known as retrospective studies. In this study, data collection will initiate before treatment, to obtain consistent baseline evaluations from all study participants undergoing the gamma knife treatment and at specific intervals following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women age 18 years or older
- •Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
- •Tremor following prior first line therapy with either propranolol or primidone
- •Must be able to undergo MRI of brain and CT of head for treatment planning
- •Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale
排除标准
- •Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
- •Prior whole brain radiation therapy
- •Pregnancy
结局指标
主要结局
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
时间窗: Baseline, 6, 12, 24, and 36 Months Post Treatment
The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.
次要结局
- Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy(Baseline, 6, 12, 24, and 36 Months Post Treatment)