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

3 T Multimodal MRI in Idiopathic RBD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03072940
Acronym
ALICE
Enrollment
42
Registered
2017-03-08
Start date
2014-02-28
Completion date
2015-12-31
Last updated
2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, REM Sleep Behavior Disorder

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.

Interventions

OTHERClinical 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

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Signal in the subcoeruleus/coeruleus complex24hBrain imaging signal in the subcoeruleus/coeruleus complex in 3T multimodal MRI, using neuromelanin-sensitive sequence

Secondary

MeasureTime frameDescription
Substantia nigra quantity24hsize of the substantia nigra
Quality of Sleep24hMeasures in videopolysomnography of efficiency of sleep
Cognition24hCognition status (MoCA test)
Olfactory function24hOlfactory function (sniff test)
Color vision24hColor vision function

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026