Subthalamic Nuclei (STN) Local Field Potentials to Investigate Motor Control During REM Sleep Behaviour Disorder (TCSP) Secondary to Idiopathic Parkinsons Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- STN 8-30 Hz mean power
研究概览
简要总结
To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field potentials recordings, during the phasic behaviours of RBD with the electrical activity recorded at this level during the execution of voluntary movements during the "off" and the "on" phases in patients with RBD secondary to PD.
详细描述
Patient with severe Parkinson's disease (PD) with motor fluctuations are akinetic and bradykinetic during the "off" phases. Their motor status dramatically improves during "on" phases, due to the effect of dopaminergic agents.
In the off phases, the plasmatic levels of dopaminergic drugs are the lowest. The plasmatic levels of dopaminergic drugs are also very low during nocturnal sleep.
Nevertheless, PD patients may show vigorous and rapid movements during REM Behaviour Disorder (RBD). Thirty-three to 46% of the patients with PD have RBD.
Akinesia and bradykinesia are the consequence of a hyperactivity of the SubThalamic Nuclei (STN). The electrophysiological correlate of this hyperactivity causing akinesia and bradykinesia is represented by STN beta activity, recorded by local field potentials.
STN beta activity is not present during the execution of a voluntary movement at an "on" phase. Levodopa therapy, which can revert akinesia and bradykinesia, also suppress STN beta activity in PD patients The STN is the surgical target for Deep Brain Stimulation (DBS) of the basal ganglia to improve the motor symptoms of PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Men and women, 35 to 70 years old, with idiopathic PD (UKPDSBB criteria) with motor fluctuations
- •having RBD according to the International Classification of Sleep Disorders, 2nd edition (ICSD-2) criteria
- •Eligible to neurosurgical treatment of PD by implantation of intracranial electrodes for the DBS of STN
- •Giving a written informed consent
- •Affiliated to the French social security program
排除标准
- •Atypical or secondary parkinsonian syndrome
- •Cognitive impairment which may compromise the understanding and patient's participation to the protocol (Mattis dementia rating scale score ≥ 136)
- •Patient under guardianship, trusteeship or judicial protection
- •Pregnancy or breastfeeding
- •Patient participating to another clinical research study in the same period
结局指标
主要结局
STN 8-30 Hz mean power
时间窗: Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.
Difference of the mean power of the 8-30 Hz frequency band at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "off" phase.
次要结局
- Difference of the mean power of the 8-30 Hz and 60-90 Hz frequency bands at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "on" phase.(Outcome measures are assessed at days 2 and 3 and nights 1 and 2.)
- Frequency spectrum at the NST during non REM sleep (N1, N2 and N3 stages), REM sleep (R) and nocturnal wake.(Outcome measures are assessed at days 2 and 3 and nights 1 and 2)
- Frequency spectrum at NST REM sleep without atonia and REM sleep with atonia.(Outcome measures are assessed at days 2 and 3 and nights 1 and 2.)
- Difference of the mean power of the 8-13 Hz, 14-30 Hz and 60-90 Hz frequency bands at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "off" phase.(Outcome measures are assessed at days 2 and 3 and nights 1 and 2.)