NCT03060239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 17, 2017

Last Update Submit

February 8, 2021

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseNear infrared SpectroscopyREM sleep behaviour disorderSupplementary motor area

Outcome Measures

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".

    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.

    24 hours

Secondary Outcomes (2)

  • Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby.

    24 hours

  • Difference of movement speed measured by accelerometers under different conditions.

    24 hours

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients with Parkinson's disease with severe REM sleep behaviour disorder according to International Classification of Sleep Disorders (ICSD2) criteria.

Other: Near Infrared Spectroscopy

Interventions

Near Infrared SpectroscopyOTHER

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

Experimental arm

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Beau Soleil

Montpellier, 34070, France

Location

MeSH Terms

Conditions

Parkinson DiseaseREM Sleep Behavior Disorder

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesREM Sleep ParasomniasParasomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

April 11, 2017

Primary Completion

April 11, 2019

Study Completion

April 12, 2019

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

FR(1)