Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder (RevesParkNST)
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Synchronised video-polysomnography
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring REM behaviour disorder, Subthalamic nucleus, Local field potential, Motor control
Eligibility Criteria
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
Sites / Locations
- University Hospital of Purpan
- University Hospital of Rangueil
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Synchronised video-polysomnography
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Frequency spectrum at NST REM sleep without atonia and REM sleep with atonia.
Frequency spectrum at the NST during non REM sleep (N1, N2 and N3 stages), REM sleep (R) and nocturnal wake.
Full Information
NCT ID
NCT01886131
First Posted
June 20, 2013
Last Updated
February 21, 2017
Sponsor
University Hospital, Toulouse
Collaborators
Grenoble Institut des Neurosciences
1. Study Identification
Unique Protocol Identification Number
NCT01886131
Brief Title
Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder
Acronym
RevesParkNST
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Grenoble Institut des Neurosciences
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
REM behaviour disorder, Subthalamic nucleus, Local field potential, Motor control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synchronised video-polysomnography
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Synchronised video-polysomnography
Other Intervention Name(s)
Synchronised video-polysomnography and STN local field potentials recordings.
Intervention Description
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.
Primary Outcome Measure Information:
Title
STN 8-30 Hz mean power
Description
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.
Time Frame
Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro-Luca RATTI, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Purpan
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital of Rangueil
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder
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