Back to resultsExploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS (NIRS-RBD)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Near Infrared Spectroscopy
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring Parkinson Disease, Near infrared Spectroscopy, REM sleep behaviour disorder, Supplementary motor area
Eligibility Criteria
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
Sites / Locations
- Clinique Beau Soleil
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
Patients with Parkinson's disease with severe REM sleep behaviour disorder according to International Classification of Sleep Disorders (ICSD2) criteria.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Difference of movement speed measured by accelerometers under different conditions.
Full Information
NCT ID
NCT03060239
First Posted
February 17, 2017
Last Updated
February 8, 2021
Sponsor
Clinique Beau Soleil
Collaborators
Université Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03060239
Brief Title
Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Beau Soleil
Collaborators
Université Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Near infrared Spectroscopy, REM sleep behaviour disorder, Supplementary motor area
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Patients with Parkinson's disease with severe REM sleep behaviour disorder according to International Classification of Sleep Disorders (ICSD2) criteria.
Intervention Type
Other
Intervention Name(s)
Near Infrared Spectroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
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".
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby.
Description
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.
Time Frame
24 hours
Title
Difference of movement speed measured by accelerometers under different conditions.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
12. IPD Sharing Statement
Learn more about this trial
Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS
We'll reach out to this number within 24 hrs