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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
Sponsor:
Collaborator:
Université Montpellier
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Near Infrared Spectroscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. Difference of movement speed measured by accelerometers under different conditions. [ Time Frame: 24 hours ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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France
Clinique Beau Soleil Recruiting
Montpellier, France, 34070
Contact: Valérie Cochen De Cock    0033467789847    valerie.cochen@gmail.com   
Principal Investigator: Valérie Cochen De Cock         
Sponsors and Collaborators
Clinique Beau Soleil
Université Montpellier

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Responsible Party: Clinique Beau Soleil
ClinicalTrials.gov Identifier: NCT03060239     History of Changes
Other Study ID Numbers: 2016-A01532-42
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinique Beau Soleil:
Parkinson Disease
Near infrared Spectroscopy
REM sleep behaviour disorder
Supplementary motor area

Additional relevant MeSH terms:
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Parkinson Disease
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases