Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change of UPDRS III score
研究概览
简要总结
To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.
详细描述
To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.
In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Parkinson's disease
- •The clinical decision of DBS treatment
- •The clinical inclusion criteria of DBS treatment:
- •drug-resistant tremor
- •severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication
- •an improvement of UPDRS III scores over 30 % in levodopa challenge test.
排除标准
- •The general exclusion criteria for DBS treatment:
- •a major depression
- •on-going psychosis
- •a significant brain atrophy observed in a brain MRI
- •a suspicion of atypical parkinsonism
- •marked cognitive decline.
结局指标
主要结局
The change of UPDRS III score
时间窗: 6 months
The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score
次要结局
- Electrode trajectory(6 months)
- The change of levodopa equivalent dose, LED(6 months)
研究者
Maija Koivu
Principal Investigator
Hospital District of Helsinki and Uusimaa