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NCT Number: NCT02984137

Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

This is a prospective cohort study to evaluate degenerative changes in the brain by performing functional imaging analysis in patients with RBD and its correlations with clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes with functional imaging measures and olfactory and other premotor symptoms of Lewy body disease. This study also collects gene extracts and sera to develop a biomarker for early detection of neurodegeneration.

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Key information

About this study

This study will include 3 groups in relation with RBD: idiopathic RBD (iRBD), PD- RBD, normal controls without RBD. In all groups, neurological examinations, olfactory testings, nonmotor symptoms evaluations, neuropsychological evaluations (detailed outcomes are in the outcome section) will be performed at baseline evaluation after enrollment. Image data will be obtained on following modalities: brain magnetic resonance imaging (MRI), 18F-N-ω-fluoropropyl- 2β-carbomethoxy- 3β-(4-iodophenyl) nortropane ([18F]FP-CIT) positron emission tomography (PET), and 18F-fludeoxyglucose([18F]FDG) PET.

To assess progression toward Lewy body disorders, patients in iRBD group will be evaluated at 2, and 4 years of follow-up visit. Clinical, neuropsychological tests, brain MRI, and two PET scans will be administered. After 4 years, patients who are willing to participate will be additionally followed-up yearly as a routine clinical visit with clinical and neurological examinations until obvious signs of Lewy body diseases will develop.

In PD-RBD group, patients will be evaluated at 3-year follow-up period amongst days of routine clinic visits with administering clinical and neuropsychological tests.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

iRBD group:

  • A diagnosis of RBD according to the international classification of sleep disorders-2 (ICSD-2) criteria
  • No current neurological diseases related with RBD
  • Male or female aged from 30 to 80 years old at screening
  • Subject enrolled voluntarily and understood the contents of the study

PD group:

  • A diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
  • A diagnosis of RBD according to the international classification of sleep disorders-2 (ICSD-2) criteria
  • Male or female aged from 30 to 80 years old at screening
  • Subject enrolled voluntarily and understood the contents of the study

Control group:

  • No current neurological or psychiatric diseases related with RBD
  • Male or female aged from 30 to 80 years old at screening
  • Age and sex matched with those of subjects in iRBD group
  • Subject enrolled voluntarily and understood the contents of the study

Exclusion criteria

  • Clinically significant cognitive decline unable to follow the study (Mini-mental state examination [MMSE] score less than 20)
  • History of psychiatric illnesses (ex. depression)
  • Unable to walk and cooperate to the examination
  • Unable to take magnetic resonance imaging or positron emission tomography
  • Existence of illness or problems which makes difficult to be enrolled to the study judged by clinicians

Treatment and study plan

testing, evaluation, sampling

Other

neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.

Primary outcomes

  1. Frequency of development of Lewy body diseases

    Time frame: up to 4-years follow-up

    idiopathic RBD group only

Secondary outcomes

  1. Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)

    Time frame: from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)

    descriptive, intragroup analysis

  2. Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS

    Time frame: from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)

    descriptive, intragroup analysis

  3. Cognitive change measured by the neuropsychological test battery

    Time frame: from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)

    descriptive, intragroup analysis

  4. Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)

    Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)

    descriptive, intragroup analysis

  5. Functional network changes predicted by the resting-state functional MRI

    Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)

    descriptive, intragroup analysis

  6. Degenerative brain changes predicted by [18F]FP-CIT PET

    Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)

    descriptive, intragroup analysis

  7. Functional network changes predicted by [18F]FDG PET

    Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)

    descriptive, intragroup analysis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • SMG-SNU Boramae Medical Center

Registry information

Official study title

A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2016
Registry last updated
Mar 18, 2020

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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