Gait and REM Sleep Behavior Disorder

Not Applicable

Terminated

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

• Registration Number: NCT02554331
• Lead Sponsor: University Hospital, Montpellier

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:

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-17
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2015-10-17
• Study Completion: 2017-10-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients RBD	FP-CIT single-photon emission computed tomography	Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors
Patients RBD	neuropsychological evaluation	Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors
Patients RBD	Gait recording with sensors	Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors
controls healthy volunteers	neuropsychological evaluation	controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors
controls healthy volunteers	Gait recording with sensors	controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors

Primary Outcome Measures

Name	Time	Method
gait velocity	Month 24	gait speed difference between single and dual tasks

Secondary Outcome Measures

Name	Time	Method
spatio-temporal gait characteristics	Month 24	oscillation phase duration difference between single and dual tasks

Trial Locations

Locations (1)

University hospital; 🇫🇷 Montpellier, France