Gait and REM Sleep Behavior Disorder (RBD-M2H)
Primary Purpose
Parkinson's Disease, REM Sleep Behavior Disorder
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FP-CIT single-photon emission computed tomography
neuropsychological evaluation
Gait recording with sensors
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Gait, REM sleep behavior disorder, Parkinson's disease, Follow-up
Eligibility Criteria
Inclusion Criteria:
- Specific inclusion criteria for RBD patients - to reach the diagnosis criteria of RBD (International Classification of Sleep Disorders 2)
- Specific inclusion criteria for PD patients - to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank) - Hoehn Yahr score ≤ 2
Exclusion Criteria:
- Specific exclusion criteria for RBD patients - diagnosis of PD - other pathology associated to RBD diagnosis - presence of antiparkinsonism medication
- Specific exclusion criteria for PD patients - clinical signs of parkinsonian syndrome- Mini Mental State Examination < 24/30- gait disorder clinically observable
- Specific exclusion criteria for controls - neurological disease- gait disorder
Sites / Locations
- University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patients RBD
controls healthy volunteers
Arm Description
Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors
controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors
Outcomes
Primary Outcome Measures
gait velocity
gait speed difference between single and dual tasks
Secondary Outcome Measures
spatio-temporal gait characteristics
oscillation phase duration difference between single and dual tasks
Full Information
NCT ID
NCT02554331
First Posted
May 6, 2015
Last Updated
December 22, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02554331
Brief Title
Gait and REM Sleep Behavior Disorder
Acronym
RBD-M2H
Official Title
Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Study Start Date
April 17, 2014 (Actual)
Primary Completion Date
October 17, 2015 (Actual)
Study Completion Date
October 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment.
The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers:
to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
to track their evolution in the parallel with the disease progression.
Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).
Secondary objective:
In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).
In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds.
In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, REM Sleep Behavior Disorder
Keywords
Gait, REM sleep behavior disorder, Parkinson's disease, Follow-up
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients RBD
Arm Type
Experimental
Arm Description
Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors
Arm Title
controls healthy volunteers
Arm Type
Other
Arm Description
controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors
Intervention Type
Radiation
Intervention Name(s)
FP-CIT single-photon emission computed tomography
Intervention Description
FP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological evaluation
Intervention Description
Assessment of:
overall cognitive function
executive functions
visuospatial functions
Nonverbal memory
verbal memory
Evaluation of hearing ability of time perception and sensorimotor synchronization from selected tasks the Battery of assessment of auditory sensorimotor and timing abilities
Beck Depression Inventory
Intervention Type
Other
Intervention Name(s)
Gait recording with sensors
Intervention Description
Gait recording with sensors
Primary Outcome Measure Information:
Title
gait velocity
Description
gait speed difference between single and dual tasks
Time Frame
Month 24
Secondary Outcome Measure Information:
Title
spatio-temporal gait characteristics
Description
oscillation phase duration difference between single and dual tasks
Time Frame
Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Specific inclusion criteria for RBD patients - to reach the diagnosis criteria of RBD (International Classification of Sleep Disorders 2)
Specific inclusion criteria for PD patients - to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank) - Hoehn Yahr score ≤ 2
Exclusion Criteria:
Specific exclusion criteria for RBD patients - diagnosis of PD - other pathology associated to RBD diagnosis - presence of antiparkinsonism medication
Specific exclusion criteria for PD patients - clinical signs of parkinsonian syndrome- Mini Mental State Examination < 24/30- gait disorder clinically observable
Specific exclusion criteria for controls - neurological disease- gait disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Cochen De Cock, MD
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Gait and REM Sleep Behavior Disorder
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