Gait and REM Sleep Behavior Disorder

NCT02554331 | Terminated

• 1 other identifier: 9183
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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. 1.to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
2. 2.to track their evolution in the parallel with the disease progression.
3. 3.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).
4. 4.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.
5. 5.In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

Conditions

Parkinson's Disease; REM Sleep Behavior Disorder

Keywords

Gait; REM sleep behavior disorder; Parkinson's disease; Follow-up

Outcome Measures

Primary Outcomes (1)

• gait velocity

  gait speed difference between single and dual tasks

  Month 24

Secondary Outcomes (1)

• spatio-temporal gait characteristics

  Month 24

Study Arms (2)

Patients RBD

EXPERIMENTAL

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; Behavioral: neuropsychological evaluation; Other: Gait recording with sensors

controls healthy volunteers

OTHER

controls healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors

Behavioral: neuropsychological evaluation; Other: Gait recording with sensors

Interventions

FP-CIT single-photon emission computed tomography RADIATION

FP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.

Patients RBD

neuropsychological evaluation BEHAVIORAL

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

Patients RBD; controls healthy volunteers

Gait recording with sensors OTHER

Gait recording with sensors

Patients RBD; controls healthy volunteers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

University hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Valérie Cochen De Cock, MD

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: September 18, 2015
• Study Start: April 17, 2014
• Primary Completion: October 17, 2015
• Study Completion: October 17, 2017
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

FR (1)