NCT02795663已完成早期 1 期
Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
研究概览
简要总结
- Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
- Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
- Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting Parkinson disease and treated by STN-DBS.
- •For comparison patients: Patients treated by DBS in other target.
排除标准
- •Patients who cannot be treated by DBS
研究组 & 干预措施
non STN
Experimental
5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording
干预措施: NIRS EEG HR recording (Device)
control
Experimental
20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording
干预措施: NIRS EEG HR recording (Device)
parkinson's patient stimulated at STN level
Experimental
15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording
干预措施: NIRS EEG HR recording (Device)
结局指标
主要结局
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
时间窗: 1 month,
under " on " and " off " stimulation during a motor task.
次要结局
- Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)(1 month)
- Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation(1 month)
- Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation(1 month)
- Study of QUIP score (QUIP scale)(3 month)
- Study of delayed discounting task (DDT) score(3 months)
- Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation(1 month)
研究者
研究点 (2)
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