Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder (RevesParkNST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01886131|
Recruitment Status : Terminated (Recruitment)
First Posted : June 25, 2013
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: Synchronised video-polysomnography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Subthalamic Nuclei (STN) Local Field Potentials to Investigate Motor Control During REM Sleep Behaviour Disorder (TCSP) Secondary to Idiopathic Parkinsons Disease (PD)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2014|
|Experimental: Synchronised video-polysomnography||
Other: Synchronised video-polysomnography
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.
Other Name: Synchronised video-polysomnography and STN local field potentials recordings.
- STN 8-30 Hz mean power [ Time Frame: 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.
- 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886131
|University Hospital of Purpan|
|Toulouse, Midi-Pyrénées, France, 31059|
|University Hospital of Rangueil|
|Toulouse, Midi-Pyrénées, France, 31059|
|Principal Investigator:||Pietro-Luca RATTI, MD||Toulouse University Hospital|