Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS

NCT03060239 — Not applicable, Completed, 13 participants, Clinique Beau Soleil

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Exploration of the Mechanism of Movement Improvement During Rapid Eye Movement (REM) Sleep Behaviour Disorder (RBD) in Parkinson's Disease Using Near-infrared Spectroscopy (NIRS)

Registry	NCT03060239, acronym NIRS-RBD
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	13 (Actual)
Sponsor	Clinique Beau Soleil (Other); collaborators: Université Montpellier
Conditions	Parkinson Disease
Interventions	Near Infrared Spectroscopy (Other)
Dates	start 2017-04-11, primary completion 2019-04-11, completion 2019-04-12, first posted 2017-02-23, last updated 2021-02-09
Locations	1 site in France

-Summary

The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's disease and to explore the neuronal network involved in this improvement using NIRS.

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+Detailed description

The aim of this study is to compare the quality of movement during REM sleep during RBD episodes and movement awake without and with dopaminergic treatment while measuring cortical activity using NIRS.

+Arms and interventions

Arm	Type	Interventions	Description
Experimental arm	Experimental	Other: Near Infrared Spectroscopy	Patients with Parkinson's disease with severe REM sleep behaviour disorder according to International Classification of Sleep Disorders (ICSD2) criteria.

Near Infrared Spectroscopy (Other): Use of the near-infrared-spectroscopy (NIRS) to explore the cortical mechanism by which this sleep disorder would allow a disappearance of parkinsonian signs at night

+Outcome measures

Primary outcomes

Difference of signal NIRS on the supplementary motor area (SMA) during the movement realized during the REM sleep behaviour disorder (RBD) and reproduced in standby in the patient parkinsonian in "on". [24 hours]: Difference of signal NIRS on the supplementary motor area (SMA) during the movement realized during the REM sleep behaviour disorder (RBD) and reproduced in standby in the patient parkinsonian in "on" (means that the patient is under effective dopaminergic treatment). The NIRS signal corresponds to the area under curve (AUC) of the oxyhemoglobin (O2Hb) and desoxyhemoglobin concentration's variation during duration of the movement.

Secondary outcomes

Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby. [24 hours]: Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on"(means that the patient is under effective dopaminergic treatment ) and movement "off" (means that the patient has been weaned from any treatment for several hours), RBD (REM sleep behavior disorder), and in standby.
Difference of movement speed measured by accelerometers under different conditions. [24 hours]

+Eligibility

Sex: All, ages: 40 Years to 90 Years

Inclusion Criteria:

* Idiopathic Parkinson's Disease (Hughes AJ et al., 2001)
* Patients with REM sleep behaviour sleep disorder according to the ICSD2 (International Classification of Sleep Disorders 2) criteria and frequent reported several times per week by the spouse
* Informed written consent signed
* Patient aged 40 to 90 years
* Affiliate or benefiting from a social security scheme.

Exclusion Criteria:

* Atypical Parkinson's Syndromes
* Patient not accepting polysomnography

  * Contraindications to cerebral Magnetic Resonnance Imaging (MRI): pacemaker, cochlear implants, certain heart valves, claustrophobia, pregnancy.
  * Limit of validity of the MRI: if the patient presents dyskinesias preventing immobile maintenance of a few minutes in the MRI for the acquisition of images

+Locations (1)

Facility	City	Country	Status
Clinique Beau Soleil	Montpellier	France