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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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. Sponsor: University Hospital, Toulouse

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]
  • Average power in the 8-13 and 14-30 frequency bands at the NST during the perception of five emotions (neutral, anger, fear, joy, sadness), in the "on" phase. [ Time Frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2. ]


Information By: University Hospital, Toulouse

Dates:
Date Received: June 20, 2013
Date Started: June 2013
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017