Study of Symptoms Related to the Lesion Effect Associated With the Implantation of Electrodes for Stimulation of the Subthalamic Nuclei in the Treatment of Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Assessment of change of mania symptoms
研究概览
简要总结
This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.
The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).
详细描述
The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Major patient
- •Diagnosis of Parkinson's disease (ICD-10)
- •L-dopa test must be positive
- •Participants who gave their informed, written consent
排除标准
- •Severe psychiatric disorder
- •Major neurocognitive disorder contraindicating surgery
结局指标
主要结局
Assessment of change of mania symptoms
时间窗: Baseline, 72 hours, 1 month and 3 months after surgery
The variation of Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.
次要结局
- Assessment of confusion(72 hours and 3 months after surgery)
- Assessment of change of depressive symptoms(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of change of Impulsivity(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of change of Behavior(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of change of Apathy(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of personality(Baseline)
- Assessment of executive functions(Baseline, 72 hours, 3 months after surgery)