Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS (NIRS-RBD)
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|ClinicalTrials.gov Identifier: NCT03060239|
Recruitment Status : Unknown
Verified February 2017 by Clinique Beau Soleil.
Recruitment status was: Recruiting
First Posted : February 23, 2017
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: Near Infrared Spectroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Experimental arm
Patients with Parkinson's disease with severe REM sleep behaviour disorder according to International Classification of Sleep Disorders (ICSD2) criteria.
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
- 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". [ Time Frame: 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.
- Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby. [ Time Frame: 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. [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060239
|Clinique Beau Soleil||Recruiting|
|Montpellier, France, 34070|
|Contact: Valérie Cochen De Cock 0033467789847 firstname.lastname@example.org|
|Principal Investigator: Valérie Cochen De Cock|