Parkinson's DiseaseRBD-M2HNCT02554331
Gait and REM Sleep Behavior Disorder
A study testing FP-CIT single-photon emission computed tomography, neuropsychological evaluation and Gait recording with sensors in people with Parkinson's Disease and REM Sleep Behavior Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, REM Sleep Behavior Disorder
- What is being tested?
- FP-CIT single-photon emission computed tomography, neuropsychological evaluation and Gait recording with sensors
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2014to 17 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques
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:
Read more
- 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)
- Conditions
- Parkinson's Disease, REM Sleep Behavior Disorder
- Being tested
- FP-CIT single-photon emission computed tomography, neuropsychological evaluation, Gait recording with sensors
- Keywords
- Gait, REM sleep behavior disorder, Parkinson's disease, Follow-up
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP-CIT single-photon emission computed tomographyRadiation
FP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
neuropsychological evaluationBehavioural
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 sensorsOther
Gait recording with sensors
| Study group | Role | What they receive |
|---|---|---|
| Patients RBD | Experimental | Patients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors Receives: 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 Receives: Behavioral: neuropsychological evaluation; Other: Gait recording with sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait velocity
gait speed difference between single and dual tasks
Measured: Month 24
Secondary outcomes (1)
spatio-temporal gait characteristics
oscillation phase duration difference between single and dual tasks
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start17 Apr 2014
- Primary completion17 Oct 2015
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Valérie Cochen De Cock, MD, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554331
- Sponsor's protocol ID
- 9183
- Acronym
- RBD-M2H
- Status last verified
- Dec 2021
- First submitted
- 6 May 2015
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques
- ClinicalTrials.gov ID
- NCT02554331
- Acronym / sponsor ID
- RBD-M2H / 9183
- Conditions
- Parkinson's Disease, REM Sleep Behavior Disorder
- Keywords
- Gait, REM sleep behavior disorder, Parkinson's disease, Follow-up
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 17 Apr 2014 (actual)
- Primary completion
- 17 Oct 2015 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients RBD | Experimental | Radiation: FP-CIT single-photon emission computed tomography, Behavioral: neuropsychological evaluation, Other: Gait recording with sensorsPatients RBD subject to FP-CIT single-photon emission computed tomography and Neuropsychological evaluation and Gait recording with sensors |
| controls healthy volunteers | Other | Behavioral: neuropsychological evaluation, Other: Gait recording with sensorscontrols healthy volunteers subject to Neuropsychological evaluation and Gait recording with sensors |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP-CIT single-photon emission computed tomographyFP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons. | Radiation | Patients RBD |
| neuropsychological evaluationAssessment 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 | Behavioural | Patients RBD, controls healthy volunteers |
| Gait recording with sensorsGait recording with sensors | Other | Patients RBD, controls healthy volunteers |
Primary outcome
gait velocity
Time frame: Month 24
gait speed difference between single and dual tasks
1 secondary outcome
spatio-temporal gait characteristics
Time frame: Month 24
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Cochen De Cock, MD principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FP-CIT single-photon emission computed tomography, neuropsychological evaluation and Gait recording with sensors in people with Parkinson's Disease and REM Sleep Behavior Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait velocity (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.