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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Near Infrared Spectroscopy

• Registration Number: NCT03060239
• Lead Sponsor: Clinique Beau Soleil

Brief 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.

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.

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Study Start: 2017-04-11
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinique Beau Soleil; 🇫🇷 Montpellier, France