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Gait and REM Sleep Behavior Disorder

NCT ID: NCT02554331

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-17

Study Completion Date

2017-10-17

Brief Summary

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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

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Conditions

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Parkinson's Disease REM Sleep Behavior Disorder

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients RBD

Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors

Group Type EXPERIMENTAL

FP-CIT single-photon emission computed tomography

Intervention Type RADIATION

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

neuropsychological evaluation

Intervention Type 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

Gait recording with sensors

Intervention Type OTHER

Gait recording with sensors

controls healthy volunteers

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

Group Type OTHER

neuropsychological evaluation

Intervention Type 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

Gait recording with sensors

Intervention Type OTHER

Gait recording with sensors

Interventions

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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.

Intervention Type RADIATION

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

Intervention Type BEHAVIORAL

Gait recording with sensors

Gait recording with sensors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Montpellier

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie Cochen De Cock, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

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University hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9183

Identifier Type: -

Identifier Source: org_study_id