Brain Imaging in the Idiopathic REM Sleep Behavior Disorder (ALICE) (ALICE)
March 7, 2017 updated by: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
3 T Multimodal MRI in Idiopathic RBD
Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease.
However, iRBD can precede parkinsonism and dementia by several years.
The causes of the loss of muscle atonia during REM sleep in these patients are unclear.
Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD.
Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers.
All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75013
- Pitié Salpetrière Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- idiopathic RBD (criteria of the international classification of sleep disorders-3)
For healthy controls : no neurologic or psychiatric disorder
Exclusion Criteria:
- Contraindication to MRI
- Do not speak French
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy volunteers
|
Clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging
|
|
Patients with idiopathic RBD
|
Clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Signal in the subcoeruleus/coeruleus complex
Time Frame: 24h
|
Brain imaging signal in the subcoeruleus/coeruleus complex in 3T multimodal MRI, using neuromelanin-sensitive sequence
|
24h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substantia nigra quantity
Time Frame: 24h
|
size of the substantia nigra
|
24h
|
|
Quality of Sleep
Time Frame: 24h
|
Measures in videopolysomnography of efficiency of sleep
|
24h
|
|
Cognition
Time Frame: 24h
|
Cognition status (MoCA test)
|
24h
|
|
Olfactory function
Time Frame: 24h
|
Olfactory function (sniff test)
|
24h
|
|
Color vision
Time Frame: 24h
|
Color vision function
|
24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2014
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (ACTUAL)
March 8, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2017
Last Update Submitted That Met QC Criteria
March 7, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADOREPS_7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.