Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- distance between stimulation electrode and motor fibers in mm
研究概览
简要总结
The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.
详细描述
The main goal is to find out what are the optimal distances to these reference fiber tracts when stimulating and to find the optimal target. This has to be evaluated for each target, such as globus pallidus (Gpi), subthalamic nucleus (STN) and ventral intermediate nucleus of the thalamus (VIM) separately. This is of special importance as the investigators can demonstrate the internal capsule, which is often a generator of stimulation-induced side effects: tetanic muscle contractions, dysarthria and gaze deviations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient qualifying for deep brain stimulation on the basis of a movement disorder (Parkinson's Disease, tremor, dystonia) or chronic pain disease.
- •Informed consent
排除标准
- •Lack of consent
- •Electrical or other devices that preclude the performance of an MRI
结局指标
主要结局
distance between stimulation electrode and motor fibers in mm
时间窗: Intraoperative
Distances between the stimulation electrode and motor fibers as depicted on fiber tracking in millimeters in correlation to the threshold current for eliciting clinical side effects
次要结局
- Intraoperative intensity of stimulation in milliampere (mA)(Intraoperative)
- Change in disease score units on the TWSTR rating scale(twelve months)
- Stimulation thresholds in milliampere (mA)(Intraoperative)
- Change in disease score units on the BFMDRS rating scale(twelve months)
- Change in disease score units on the PDQ-39 rating scale(twelve months)
- Change in disease score units on the UPDRS rating scale(twelve months)
- Change in disease score units on the FTRS rating scale(twelve months)