Investigating the Use of an Interphase Gap in Biphasic Pulses in DBS for ET Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Therapeutic threshold (mA)
研究概览
简要总结
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients with essential tremor treated with Vim-DBS
- •Normal impedances of DBS circuit
- •Signed written informed consent
排除标准
- •Active psychiatric disease or active alcohol or drug abuse
- •History of recurrent or unprovoked seizures
- •Relevant comorbidities that influence objective clinical assessment
- •Pregnancy
结局指标
主要结局
Therapeutic threshold (mA)
时间窗: During uptitration of the amplitude (entire process takes 3-4 minutes)
Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)
Side effect threshold (mA)
时间窗: During uptitration of the amplitude (entire process takes 3-4 minutes)
Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)
次要结局
未报告次要终点
研究者
Myles Mc Laughlin
Assistant Professor
KU Leuven