Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.
研究概览
简要总结
The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.
详细描述
The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.
Twenty parkinsonian patients will be randomised : the delay between inclusion and neurostimulation wil be lengthened 3 months for one group, compared to the second one. The energy expenditure, at rest and after ingestion of a test meal, will be compared between the group of patients that had been neurostimulated and the group whose intervention has been postponed. Weight changes, energy intake, leptin level, neurophysiological parameters will be compared between both groups, and the nature and repartition of the weight gain will be assessed in the neurostimulated group. An eventual link between motor factors, pharmacological factors, and gain weight will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 and 70; male or female; parkinson disease, with levo dopa response (at least 30%); severe but stable incapacity; no dementia, no psychosis, no depression; normal brain scanner done during the last 2 years.
排除标准
- •diabetes thyroid disease pacemaker coagulation troubles previous drug abuse
研究组 & 干预措施
1
Deep Brain Stimulation of the Subthalamic Nucleus
干预措施: Deep brain stimulation (Procedure)
2
Later Deep Brain Stimulation of the Subthalamic Nucleus
干预措施: Deep brain stimulation (Procedure)
结局指标
主要结局
Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.
时间窗: After surgery and at 3 months
次要结局
- UDPRS scale(before surgery and after 3 months)
- increase of energy intake(At visit 1 and at 3 months)
- Weight gain(At visit 1 and at 3 months)
- cognitive and psychological assessments(before surgery and after 3 months)
- leptin, glucose, insulin blood levels(At visite 1 and at 3 months)