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Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

Primary Purpose

Parkinson Disease, REM Sleep Behavior Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
testing, evaluation, sampling
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Lewy body disease, REM Sleep Behavior Disorder, Parkinson disease, Imaging, Bio-markers, Prospective cohort

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

idiopathic RBD group

incident PD group

Control

Arm Description

A group of patients diagnosed as idiopathic RBD that is confirmed by polysomnography. Interventions as testing, evaluation, samplings at baseline, then repeat at 2 years and 4 years of prospective follow-up. thereafter only clinical observations until Lewy body disease is diagnosed.

A group of patients who are newly diagnosed as Parkinson's disease, and never been treated with prolonged history of probable RBD. Interventions as testing, evaluation, sampling at baseline and then evaluations only at 3 year follow-up after anti-parkinsonian treatment.

Control group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only.

Outcomes

Primary Outcome Measures

Frequency of development of Lewy body diseases
idiopathic RBD group only

Secondary Outcome Measures

Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)
descriptive, intragroup analysis
Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS
descriptive, intragroup analysis
Cognitive change measured by the neuropsychological test battery
descriptive, intragroup analysis
Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)
descriptive, intragroup analysis
Functional network changes predicted by the resting-state functional MRI
descriptive, intragroup analysis
Degenerative brain changes predicted by [18F]FP-CIT PET
descriptive, intragroup analysis
Functional network changes predicted by [18F]FDG PET
descriptive, intragroup analysis

Full Information

First Posted
November 30, 2016
Last Updated
March 17, 2020
Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02984137
Brief Title
Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder
Official Title
A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, REM Sleep Behavior Disorder
Keywords
Lewy body disease, REM Sleep Behavior Disorder, Parkinson disease, Imaging, Bio-markers, Prospective cohort

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
idiopathic RBD group
Arm Type
Experimental
Arm Description
A group of patients diagnosed as idiopathic RBD that is confirmed by polysomnography. Interventions as testing, evaluation, samplings at baseline, then repeat at 2 years and 4 years of prospective follow-up. thereafter only clinical observations until Lewy body disease is diagnosed.
Arm Title
incident PD group
Arm Type
Active Comparator
Arm Description
A group of patients who are newly diagnosed as Parkinson's disease, and never been treated with prolonged history of probable RBD. Interventions as testing, evaluation, sampling at baseline and then evaluations only at 3 year follow-up after anti-parkinsonian treatment.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only.
Intervention Type
Other
Intervention Name(s)
testing, evaluation, sampling
Intervention Description
neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.
Primary Outcome Measure Information:
Title
Frequency of development of Lewy body diseases
Description
idiopathic RBD group only
Time Frame
up to 4-years follow-up
Secondary Outcome Measure Information:
Title
Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
Title
Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
Title
Cognitive change measured by the neuropsychological test battery
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
Title
Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years and 4-years follow-up (iRBD group only)
Title
Functional network changes predicted by the resting-state functional MRI
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years and 4-years follow-up (iRBD group only)
Title
Degenerative brain changes predicted by [18F]FP-CIT PET
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years and 4-years follow-up (iRBD group only)
Title
Functional network changes predicted by [18F]FDG PET
Description
descriptive, intragroup analysis
Time Frame
from baseline to 2-years and 4-years follow-up (iRBD group only)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee-Young Lee, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

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