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OpenTrials
Completed

NCT Number: NCT03072940

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pitie Salpetriere hospital

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical investigations

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Substantia nigra quantity

    Time frame: 24h

    size of the substantia nigra

  2. Quality of Sleep

    Time frame: 24h

    Measures in videopolysomnography of efficiency of sleep

  3. Cognition

    Time frame: 24h

    Cognition status (MoCA test)

  4. Olfactory function

    Time frame: 24h

    Olfactory function (sniff test)

  5. Color vision

    Time frame: 24h

    Color vision function

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • NRJ Foundation - Institute of France
  • National Research Agency, France

Registry information

Official study title

3 T Multimodal MRI in Idiopathic RBD

Acronym: ALICE

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 8, 2017
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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