Gait and REM Sleep Behavior Disorder

Parkinson's Disease Clinical Trial

— RBD-M2H  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02554331
• Other study ID #: 9183
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2014
• Est. completion date: October 17, 2017

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson's Disease
• REM Sleep Behavior Disorder

Intervention

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

Locations

Country	Name	City	State
France	University hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait velocity	gait speed difference between single and dual tasks	Month 24
Secondary	spatio-temporal gait characteristics	oscillation phase duration difference between single and dual tasks	Month 24