Brain Imaging in the Idiopathic REM Sleep Behavior Disorder (ALICE)

NCT ID: NCT03072940

Last Updated: 2017-03-09

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

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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REM Sleep Behavior Disorder Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with idiopathic RBD

Clinical investigations

Intervention Type OTHER

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

Healthy volunteers

Clinical investigations

Intervention Type OTHER

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

Interventions

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Clinical investigations

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NRJ Foundation - Institute of France

UNKNOWN

Sponsor Role collaborator

National Research Agency, France

OTHER

Sponsor Role collaborator

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pitie Salpetriere hospital

Paris, , France

Site Status

Countries

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France

References

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Ehrminger M, Latimier A, Pyatigorskaya N, Garcia-Lorenzo D, Leu-Semenescu S, Vidailhet M, Lehericy S, Arnulf I. The coeruleus/subcoeruleus complex in idiopathic rapid eye movement sleep behaviour disorder. Brain. 2016 Apr;139(Pt 4):1180-8. doi: 10.1093/brain/aww006. Epub 2016 Feb 26.

Reference Type RESULT
PMID: 26920675 (View on PubMed)

Other Identifiers

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ADOREPS_7

Identifier Type: -

Identifier Source: org_study_id

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