Gait and REM Sleep Behavior Disorder (RBD-M2H)

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

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:

1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
2. 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:

1. 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).
2. 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.
3. In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease; REM Sleep Behavior Disorder
• Intervention / Treatment: Radiation: FP-CIT single-photon emission computed tomography; Behavioral: neuropsychological evaluation; Other: Gait recording with sensors

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients RBD; 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; FP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.; Behavioral: neuropsychological evaluation; 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; Other: Gait recording with sensors; Gait recording with sensors
OTHER: controls healthy volunteers; controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors	Behavioral: neuropsychological evaluation; 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; Other: Gait recording with sensors; Gait recording with sensors

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Université Montpellier
• Investigators: Principal Investigator: Valérie Cochen De Cock, MD, University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2014
• Primary Completion (ACTUAL): October 17, 2015
• Study Completion (ACTUAL): October 17, 2017

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (ESTIMATE): September 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Gait; Follow-up; Parkinson's disease; REM sleep behavior disorder
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parasomnias; REM Sleep Parasomnias; Parkinson Disease; Mental Disorders; REM Sleep Behavior Disorder
• Other Study ID Numbers: 9183 (Fred Hutch/University of Washington Cancer Consortium)