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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Terminated

CT.gov ID

NCT01886131

Collaborator

Grenoble Institut des Neurosciences (Other)

Enrollment

Locations

Arm

Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Synchronised video-polysomnography	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

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 :

Jun 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Synchronised video-polysomnography and STN local field potentials recordings.

Arm

Intervention/Treatment

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 Names:

Synchronised video-polysomnography and STN local field potentials recordings.

Outcome Measures

Primary Outcome Measures

STN 8-30 Hz mean power [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.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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