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

Healthy Clinical Trial

— ALICE  

Official title:

3 T Multimodal MRI in Idiopathic RBD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072940
• Other study ID #: ADOREPS_7
• Status: Completed
• Phase: N/A
• First received: February 28, 2017
• Last updated: March 7, 2017
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Mental Disorders
• REM Sleep Behavior Disorder

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Pitie Salpetriere hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil	National Research Agency, France, NRJ Foundation - Institute of France

Country where clinical trial is conducted

France, 

References & Publications (1)

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/br — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal in the subcoeruleus/coeruleus complex	Brain imaging signal in the subcoeruleus/coeruleus complex in 3T multimodal MRI, using neuromelanin-sensitive sequence	24h
Secondary	Substantia nigra quantity	size of the substantia nigra	24h
Secondary	Quality of Sleep	Measures in videopolysomnography of efficiency of sleep	24h
Secondary	Cognition	Cognition status (MoCA test)	24h
Secondary	Olfactory function	Olfactory function (sniff test)	24h
Secondary	Color vision	Color vision function	24h