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

Parkinson Disease Clinical Trial

— NIRS-RBD  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060239
• Other study ID #: 2016-A01532-42
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: April 12, 2019

Study information

• Verified date: February 2021
• Source: Clinique Beau Soleil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 12, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Near Infrared Spectroscopy
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

Locations

Country	Name	City	State
France	Clinique Beau Soleil	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Beau Soleil	Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	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.	24 hours
Secondary	Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby.	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.	24 hours
Secondary	Difference of movement speed measured by accelerometers under different conditions.		24 hours