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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03060239
Acronym
NIRS-RBD
Enrollment
13
Registered
2017-02-23
Start date
2017-04-11
Completion date
2019-04-12
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Near infrared Spectroscopy, REM sleep behaviour disorder, Supplementary motor area

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.

Interventions

OTHERNear 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

Sponsors

Université Montpellier
CollaboratorOTHER
Clinique Beau Soleil
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.24 hoursDifference 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

MeasureTime frameDescription
Difference of NIRS signal in different cortical regions and in different conditions: rest, movement on and off, RBD, and in standby.24 hoursDifference 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.24 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026