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

February 21, 2017 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • University Hospital of Purpan
      • Toulouse, Midi-Pyrénées, France, 31059
        • University Hospital of Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Time Frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
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.
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.
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
Outcome measures are assessed at days 2 and 3 and nights 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Grenoble Institut des Neurosciences

Investigators

  • Principal Investigator: Pietro-Luca RATTI, MD, Toulouse University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (ESTIMATE)

June 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 388 02
  • AOL2012 (OTHER: Toulouse University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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