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

Completed

• Conditions: REM Sleep Behavior Disorder; Healthy
• Interventions: Other: Clinical investigations

• Registration Number: NCT03072940
• Lead Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Study First Submitted: 2017-02-28
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-07
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Clinical investigations	-
Patients with idiopathic RBD	Clinical investigations	-

Primary Outcome Measures

Name	Time	Method
Signal in the subcoeruleus/coeruleus complex	24h	Brain imaging signal in the subcoeruleus/coeruleus complex in 3T multimodal MRI, using neuromelanin-sensitive sequence

Secondary Outcome Measures

Name	Time	Method
Substantia nigra quantity	24h	size of the substantia nigra
Quality of Sleep	24h	Measures in videopolysomnography of efficiency of sleep
Cognition	24h	Cognition status (MoCA test)
Olfactory function	24h	Olfactory function (sniff test)
Color vision	24h	Color vision function

Trial Locations

Locations (1)

Pitie Salpetriere hospital; 🇫🇷 Paris, France