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Gait and REM Sleep Behavior Disorder (RBD-M2H)

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ClinicalTrials.gov Identifier: NCT02554331
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : September 18, 2015
Last Update Posted : September 18, 2015
Sponsor:
Collaborator:
Université Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

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. 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)

Condition or disease Intervention/treatment Phase
Parkinson's Disease REM Sleep Behavior Disorder Radiation: FP-CIT single-photon emission computed tomography Behavioral: neuropsychological evaluation Other: Gait recording with sensors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques
Study Start Date : April 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients RBD
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
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

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




Primary Outcome Measures :
  1. gait velocity [ Time Frame: Month 24 ]
    gait speed difference between single and dual tasks


Secondary Outcome Measures :
  1. spatio-temporal gait characteristics [ Time Frame: Month 24 ]
    oscillation phase duration difference between single and dual tasks



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554331


Contacts
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Contact: Valérie Cochen De Cock, MD 06 09 04 35 05 valerie.cochen@gmail.com

Locations
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France
University hospital Recruiting
Montpellier, France, 34295
Contact: Valérie Cochen De Cock, MD    06 09 04 35 05    valerie.cochen@gmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
Université Montpellier
Investigators
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Principal Investigator: Valérie Cochen De Cock, MD University Hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02554331     History of Changes
Other Study ID Numbers: 9183
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015
Keywords provided by University Hospital, Montpellier:
Gait
REM sleep behavior disorder
Parkinson's disease
Follow-up
Additional relevant MeSH terms:
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Parkinson Disease
REM Sleep Behavior Disorder
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders