Gait and REM Sleep Behavior Disorder | NCT02554331

Studies
Gait and REM Sleep Behavior Disorder

NCT02554331

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Dec 23, 2021Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Parkinson's Disease
REM Sleep Behavior Disorder

Interventions

FP-CIT single-photon emission computed tomography
neuropsychological evaluation
Gait recording with sensors

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2014Actual

Primary Completion Date

Oct 17, 2015Actual

Completion Date

Oct 17, 2017Actual

First Submitted Date

May 6, 2015

First Submission Date that Met QC Criteria

Sep 17, 2015

First Posted Date

Sep 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2021

Last Update Posted Date

Dec 23, 2021Actual

Name	Class
Université Montpellier	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
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:

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).
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.
In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gait velocity	gait speed difference between single and dual tasks	Month 24

Secondary Outcomes

Measure	Description	Time Frame
spatio-temporal gait characteristics	oscillation phase duration difference between single and dual tasks	Month 24

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valérie Cochen De Cock, MD	University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020187	REM Sleep Behavior Disorder

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided