Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The STN has bilateral connections with the laterodorsal nucleus/pedunculopontine tegmentum (LDT/PPN), a key structure for REM sleep regulation. The investigators hypothesize that during the execution of the phasic motor behaviours of RBD the pattern of discharge of STN differs from the one observed during voluntary movements in the off phase, in PD patients. In other terms, we expect the STN beta activity to disappear during the execution of phasic motor behaviors of RBD.

Official Title
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Subthalamic Nuclei (STN) Local Field Potentials to Investigate Motor Control During REM Sleep Behaviour Disorder (TCSP) Secondary to Idiopathic Parkinsons Disease (PD)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Synchronised video-polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synchronised video-polysomnography<br> | Other: Synchronised video-polysomnography<br>* We will record the electrical activity of the STN (local field potentials) during the 2 consecutive nights following the implantation of the electrodes in the STN for DBS. In this period, the deep brain stimulator will not yet be connected to the intracranial electrodes. The intracranial EEG signal from the STN will be synchronised with the scalp EEG and other video-polysomnographic parameters. The STN recordings during the phasic movements of RBD will be compared to the recordings obtained at the same level during a motor task.<br>* Other names: Synchronised video-polysomnography and STN local field potentials recordings.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STN 8-30 Hz mean power | 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. | Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 NST REM sleep without atonia and REM sleep with atonia. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REM behaviour disorder, Subthalamic nucleus, Local field potential, Motor control