Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 主要终点
- sleep quality
研究概览
简要总结
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.
详细描述
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
- •maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
- •no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment
排除标准
- •patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
- •women who are not post-menopausal
- •patients with other significant neurological or psychiatric disease other than essential tremor
- •patients treated with pallidotomy or thalamotomy
- •patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic
结局指标
主要结局
sleep quality
时间窗: 10 weeks
The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9.
次要结局
- Side effects(10 weeks)
- measures of tremor,voltage threshold for optimal tremor control(10 weeks)