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

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ClinicalTrials.gov Identifier: NCT01886131
Recruitment Status : Terminated (Recruitment)
First Posted : June 25, 2013
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Grenoble Institut des Neurosciences
Information provided by (Responsible Party):
University Hospital, Toulouse

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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 Name: Synchronised video-polysomnography and STN local field potentials recordings.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  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. ]
  3. 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. ]
  4. 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 ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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France
University Hospital of Purpan
Toulouse, Midi-Pyrénées, France, 31059
University Hospital of Rangueil
Toulouse, Midi-Pyrénées, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Grenoble Institut des Neurosciences
Investigators
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Principal Investigator: Pietro-Luca RATTI, MD Toulouse University Hospital
Publications:
AASM (2005). International classification of sleep disorders, 2nd ed.: Diagnostic and coding manual. Westchester, IL, American Academy of Sleep Medicine.
Buot, A., M. L. Welter, et al. (2012).
Drouin, N., L. Allard, et al. (2011). Sleep staging using Subdermal Wire Electrodes during intracerebral EEG recordings (abstract 1.133). American Epilepsy Society 65th annual meeting. Baltimore, MD., U.S.A.
Fumagalli, M., G. Giannicola, et al. (2011).
Iber, C., S. Ancoli-Israel, et al. (2007). The AASM Manual for the Scoring of Sleep and Associated Events. Rules, Terminology and Technical Specifications. Westchester, IL, American Academy of Sleep Medicine.
Luppi, P. H., O. Clement, et al. (2011).
Marceglia, S., M. Fumagalli, et al. (2011).
Martinez-Martin, P., C. Rodriguez-Blazquez, et al. (2013).
Nishida, N., T. Murakami, et al. (2011).
Rodriguez-Oroz, M. C., J. Lopez-Azcarate, et al. (2011).
Sixel-Döring, F., E. Trautmann, et al. (2011).
Trenkwalder, C., R. Kohnen, et al. (2011).
Visser, M., J. Marinus, et al. (2004).

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01886131    
Other Study ID Numbers: 12 388 02
AOL2012 ( Other Identifier: Toulouse University Hospital )
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by University Hospital, Toulouse:
REM behaviour disorder
Subthalamic nucleus
Local field potential
Motor control
Additional relevant MeSH terms:
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Parkinson Disease
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases