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

NCT01886131 | Terminated

• 2 other identifiers: 12 388 02AOL2012
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

REM behaviour disorder; Subthalamic nucleus; Local field potential; Motor control

Outcome Measures

Primary Outcomes (1)

• 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.

  Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.

Secondary Outcomes (4)

• 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

Study Arms (1)

Synchronised video-polysomnography

EXPERIMENTAL

Other: Synchronised video-polysomnography

Interventions

Synchronised video-polysomnography OTHER

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.

Also known as: Synchronised video-polysomnography and STN local field potentials recordings.

Synchronised video-polysomnography

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Grenoble Institut des Neurosciences: collaborator

Study Sites (2)

University Hospital of Purpan

Toulouse, Midi-Pyrénées, 31059, France

Location

University Hospital of Rangueil

Toulouse, Midi-Pyrénées, 31059, France

Location

Related Publications (31)

• AASM (2005). International classification of sleep disorders, 2nd ed.: Diagnostic and coding manual. Westchester, IL, American Academy of Sleep Medicine.

  BACKGROUND

• Benarroch EE. Subthalamic nucleus and its connections: Anatomic substrate for the network effects of deep brain stimulation. Neurology. 2008 May 20;70(21):1991-5. doi: 10.1212/01.wnl.0000313022.39329.65. No abstract available.

  PMID: 18490619 BACKGROUND

• Boeve BF, Silber MH, Saper CB, Ferman TJ, Dickson DW, Parisi JE, Benarroch EE, Ahlskog JE, Smith GE, Caselli RC, Tippman-Peikert M, Olson EJ, Lin SC, Young T, Wszolek Z, Schenck CH, Mahowald MW, Castillo PR, Del Tredici K, Braak H. Pathophysiology of REM sleep behaviour disorder and relevance to neurodegenerative disease. Brain. 2007 Nov;130(Pt 11):2770-88. doi: 10.1093/brain/awm056. Epub 2007 Apr 5.

  PMID: 17412731 BACKGROUND

• Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. doi: 10.1016/j.clinph.2005.05.009. Epub 2005 Jul 18.

  PMID: 16029963 BACKGROUND

• Buot, A., M. L. Welter, et al. (2012).

  BACKGROUND

• Cassidy M, Mazzone P, Oliviero A, Insola A, Tonali P, Di Lazzaro V, Brown P. Movement-related changes in synchronization in the human basal ganglia. Brain. 2002 Jun;125(Pt 6):1235-46. doi: 10.1093/brain/awf135.

  PMID: 12023312 BACKGROUND

• De Cock VC, Vidailhet M, Leu S, Texeira A, Apartis E, Elbaz A, Roze E, Willer JC, Derenne JP, Agid Y, Arnulf I. Restoration of normal motor control in Parkinson's disease during REM sleep. Brain. 2007 Feb;130(Pt 2):450-6. doi: 10.1093/brain/awl363.

  PMID: 17235126 BACKGROUND

• 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.

  BACKGROUND

• Fernandez-Mendoza J, Lozano B, Seijo F, Santamarta-Liebana E, Ramos-Platon MJ, Vela-Bueno A, Fernandez-Gonzalez F. Evidence of subthalamic PGO-like waves during REM sleep in humans: a deep brain polysomnographic study. Sleep. 2009 Sep;32(9):1117-26. doi: 10.1093/sleep/32.9.1117.

  PMID: 19750916 BACKGROUND

• Fumagalli, M., G. Giannicola, et al. (2011).

  BACKGROUND

• Hammond C, Bergman H, Brown P. Pathological synchronization in Parkinson's disease: networks, models and treatments. Trends Neurosci. 2007 Jul;30(7):357-64. doi: 10.1016/j.tins.2007.05.004. Epub 2007 May 25.

  PMID: 17532060 BACKGROUND

• Hsu, Y. T., H. Y. Lai, et al. (2012).

  BACKGROUND

• 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.

  BACKGROUND

• Kuhn AA, Trottenberg T, Kivi A, Kupsch A, Schneider GH, Brown P. The relationship between local field potential and neuronal discharge in the subthalamic nucleus of patients with Parkinson's disease. Exp Neurol. 2005 Jul;194(1):212-20. doi: 10.1016/j.expneurol.2005.02.010.

  PMID: 15899258 BACKGROUND

• Levy R, Ashby P, Hutchison WD, Lang AE, Lozano AM, Dostrovsky JO. Dependence of subthalamic nucleus oscillations on movement and dopamine in Parkinson's disease. Brain. 2002 Jun;125(Pt 6):1196-209. doi: 10.1093/brain/awf128.

  PMID: 12023310 BACKGROUND

• Luppi, P. H., O. Clement, et al. (2011).

  BACKGROUND

• Marceglia S, Fumagalli M, Priori A. What neurophysiological recordings tell us about cognitive and behavioral functions of the human subthalamic nucleus. Expert Rev Neurother. 2011 Jan;11(1):139-49. doi: 10.1586/ern.10.184.

  PMID: 21158561 BACKGROUND

• Martinez-Martin, P., C. Rodriguez-Blazquez, et al. (2013).

  BACKGROUND

• Mena-Segovia J, Bolam JP, Magill PJ. Pedunculopontine nucleus and basal ganglia: distant relatives or part of the same family? Trends Neurosci. 2004 Oct;27(10):585-8. doi: 10.1016/j.tins.2004.07.009.

  PMID: 15374668 BACKGROUND

• Nishida, N., T. Murakami, et al. (2011).

  BACKGROUND

• Oudiette, D., S. Leu-Semenescu, et al. (2012).

  BACKGROUND

• Rivlin-Etzion M, Marmor O, Heimer G, Raz A, Nini A, Bergman H. Basal ganglia oscillations and pathophysiology of movement disorders. Curr Opin Neurobiol. 2006 Dec;16(6):629-37. doi: 10.1016/j.conb.2006.10.002. Epub 2006 Nov 3.

  PMID: 17084615 BACKGROUND

• Rodriguez-Oroz, M. C., J. Lopez-Azcarate, et al. (2011).

  BACKGROUND

• Sixel-Döring, F., E. Trautmann, et al. (2011).

  BACKGROUND

• Stefani A, Galati S, Peppe A, Bassi A, Pierantozzi M, Hainsworth AH, Bernardi G, Orlacchio A, Stanzione P, Mazzone P. Spontaneous sleep modulates the firing pattern of parkinsonian subthalamic nucleus. Exp Brain Res. 2006 Jan;168(1-2):277-80. doi: 10.1007/s00221-005-0175-y. Epub 2005 Nov 18.

  PMID: 16328297 BACKGROUND

• Trenkwalder, C., R. Kohnen, et al. (2011).

  BACKGROUND

• Urbain N, Gervasoni D, Souliere F, Lobo L, Rentero N, Windels F, Astier B, Savasta M, Fort P, Renaud B, Luppi PH, Chouvet G. Unrelated course of subthalamic nucleus and globus pallidus neuronal activities across vigilance states in the rat. Eur J Neurosci. 2000 Sep;12(9):3361-74. doi: 10.1046/j.1460-9568.2000.00199.x.

  PMID: 10998119 BACKGROUND

• Urrestarazu E, Iriarte J, Alegre M, Clavero P, Rodriguez-Oroz MC, Guridi J, Obeso JA, Artieda J. Beta activity in the subthalamic nucleus during sleep in patients with Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):254-60. doi: 10.1002/mds.22351.

  PMID: 18951542 BACKGROUND

• Visser, M., J. Marinus, et al. (2004).

  BACKGROUND

• Weinberger M, Mahant N, Hutchison WD, Lozano AM, Moro E, Hodaie M, Lang AE, Dostrovsky JO. Beta oscillatory activity in the subthalamic nucleus and its relation to dopaminergic response in Parkinson's disease. J Neurophysiol. 2006 Dec;96(6):3248-56. doi: 10.1152/jn.00697.2006. Epub 2006 Sep 27.

  PMID: 17005611 BACKGROUND

• Williams D, Kuhn A, Kupsch A, Tijssen M, van Bruggen G, Speelman H, Hotton G, Loukas C, Brown P. The relationship between oscillatory activity and motor reaction time in the parkinsonian subthalamic nucleus. Eur J Neurosci. 2005 Jan;21(1):249-58. doi: 10.1111/j.1460-9568.2004.03817.x.

  PMID: 15654862 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Pietro-Luca RATTI, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (2)