Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Corticospinal excitability
研究概览
简要总结
Akinesia is one of the most prominent symptom in Parkinson's Disease (PD) patients. It typically consists in a inability to initiate voluntary movement, and it affects patients' quality of life. This study aims at exploring the influence of Deep Brain Stimulation (DBS) in the quality of motor control, and particularly of voluntary movement initiation, and its neural correlates. They will be evaluated using behavioral and motor tasks together with Transcranial Magnetic Stimulation (TMS) and electrophysiology (EMG and EEG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients that are monitored for the tuning of their DBS stimulator by Grenoble's Hospital.
- •PD patients that are hospitalized for the tuning routine 12 months after the surgical implantation.
- •Good tolerance following temporary stops of the DBS stimulator
- •Affiliated to a social security system
- •Mental abilities sufficient for performing the behavioral tasks (MMSE score >= 24, tested less than 6 months ago)
排除标准
- •Patients that are concerned by articles L1121-5, L1121-6, L1121-7 and L1121-8 of French Code de la Santé Publique,
- •History of psychiatric or neurological illness other than PD
- •Patients that are currently excluded from an other clinical trial
- •Contraindications for TMS practice
- •Inability to stay seated without pain for two hours
- •Pregnancy
结局指标
主要结局
Corticospinal excitability
时间窗: 60 minutes
Corticospinal excitability is measured trough the amplitudes of TMS-evoked motor potentials recorded on the EMG at rest, and during the behavioral and motor tasks, in the two experimental conditions (DBS stimulator ON and OFF).
次要结局
- Cortical excitability(60 minutes)
- Cortico-subcortical connectivity(20 minutes)
- Correlation between behavioral and neural responses(60 minutes)