Gait and REM Sleep Behavior Disorder

NCT02554331 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-12-23

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Université Montpellier

    collaborator OTHER
  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Valérie Cochen De Cock, MD · University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-17
Primary Completion
2015-10-17
Completion
2017-10-17

Countries

  • France

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554331 on ClinicalTrials.gov