Gait and REM Sleep Behavior Disorder

Study Overview
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Brief Summary
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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)

Official Title
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Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques

Conditions
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Parkinson's Disease, REM Sleep Behavior Disorder

Intervention / Treatment
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* Radiation: FP-CIT single-photon emission computed tomography
* Behavioral: neuropsychological evaluation
* Other: Gait recording with sensors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients RBD<br>Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors | Radiation: FP-CIT single-photon emission computed tomography<br>* FP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.<br>Behavioral: neuropsychological evaluation<br>* 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<br>Other: Gait recording with sensors<br>* Gait recording with sensors<br>|
| Other: controls healthy volunteers<br>controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors | Behavioral: neuropsychological evaluation<br>* 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<br>Other: Gait recording with sensors<br>* Gait recording with sensors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait velocity | gait speed difference between single and dual tasks | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spatio-temporal gait characteristics | oscillation phase duration difference between single and dual tasks | Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, REM sleep behavior disorder, Parkinson's disease, Follow-up