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Completed

NCT Number: NCT03060239

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parasomnias Parkinsonian Disorders REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Beau Soleil

Montpellier, 34070, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near Infrared Spectroscopy

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clinique Beau Soleil

Other

Collaborators

  • Université Montpellier

Registry information

Official study 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)

Acronym: NIRS-RBD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2017
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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