NCT03875404已完成不适用
Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in tremor rating score
研究概览
简要总结
Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
- •Age ≥ 18 years
排除标准
- •Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor
- •Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)
- •Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)
- •Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)
结局指标
主要结局
Change in tremor rating score
时间窗: One year
Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor) 0 = None 1. = Slight. 2. = Moderate amplitude. 3. = Marked amplitude 4. = Severe amplitude 0 = Normal 1. = Mildly abnormal. 2. = Moderately abnormal. 3. = Marked abnormal. 4. = Severely abnormal.
次要结局
未报告次要终点
研究者
Erik H. Middlebrooks, M.D.
Principal Investigator
Mayo Clinic
研究点 (2)
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