Back to resultsProspective Study for Neuromelanin Image Analysis
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MRI Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease
Eligibility Criteria
Parkinsin group
Inclusion Criteria:
- Adults over 19 years old
- Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans
- Dopamine transporter imaging shows a significant decrease in visual dopamine intake
- A person who can read and understand the description and informed consent form
- Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion Criteria:
- Patient with a history of claustrophobia and mental illness;
- Patient with metallic substances in the body
- Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
- Pregnant or lactating women
- Other cases where the investigator judged that it is difficult to participate in the study;
Healthy volunteer group
Inclusion Criteria:
- Adults over 19 years old
- A person who has no family history or diagnostic history of movement disorders;
- A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)
- A person with a score of 27 or higher on the MMSE Test
- No Parkinson's symptoms on a neurological examination
- Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion Criteria:
- Patient with a history of central nervous system disease or cognitive disorder
- Patient with a history of claustrophobia and mental illness;
- Patient with metallic substances in the body
- Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
- Pregnant or lactating women
- Other cases where the investigator judged that it is difficult to participate in the study;
Sites / Locations
- Inje University Sanggye Paik Hospital
- Severance Hospital, Yonsei University Health SystemRecruiting
- Yong-in Severance Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient group
Healthy volunteer group
Arm Description
Patient with parkinson disease
Healthy volunteer
Outcomes
Primary Outcome Measures
Differences in Neuromelanin Volume by Age
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
Secondary Outcome Measures
Differences in Neuromelanin Volume by group
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05513794
Brief Title
Prospective Study for Neuromelanin Image Analysis
Official Title
Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heuron Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In order to develop an image analysis system that automatically detects and quantifies neuromelanin, this study aims to construct a database of a wide sample by collecting brain MRI neuromelanin images prospectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Experimental
Arm Description
Patient with parkinson disease
Arm Title
Healthy volunteer group
Arm Type
Experimental
Arm Description
Healthy volunteer
Intervention Type
Device
Intervention Name(s)
MRI Imaging
Intervention Description
Neuromelanin sequence imaging
Primary Outcome Measure Information:
Title
Differences in Neuromelanin Volume by Age
Description
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
Time Frame
Within 1 weeks after enrollment
Secondary Outcome Measure Information:
Title
Differences in Neuromelanin Volume by group
Description
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group
Time Frame
Within 1 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Parkinsin group
Inclusion Criteria:
Adults over 19 years old
Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans
Dopamine transporter imaging shows a significant decrease in visual dopamine intake
A person who can read and understand the description and informed consent form
Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion Criteria:
Patient with a history of claustrophobia and mental illness;
Patient with metallic substances in the body
Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
Pregnant or lactating women
Other cases where the investigator judged that it is difficult to participate in the study;
Healthy volunteer group
Inclusion Criteria:
Adults over 19 years old
A person who has no family history or diagnostic history of movement disorders;
A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)
A person with a score of 27 or higher on the MMSE Test
No Parkinson's symptoms on a neurological examination
Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion Criteria:
Patient with a history of central nervous system disease or cognitive disorder
Patient with a history of claustrophobia and mental illness;
Patient with metallic substances in the body
Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
Pregnant or lactating women
Other cases where the investigator judged that it is difficult to participate in the study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoomi Kim
Phone
+82 032-429-8503
Email
yoomi_kim@iheuron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phil Hyu Lee, M.D.pH.D
Organizational Affiliation
Severance Hospital, Yonsei University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
State/Province
Nowon-gu
ZIP/Postal Code
01757
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoomi Kim
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seodaemun Gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoomi Kim
Facility Name
Yong-in Severance Hospital, Yonsei University Health System
City
Gyeonggi-do
State/Province
Yongin-si
ZIP/Postal Code
16995
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoomi Kim
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Study for Neuromelanin Image Analysis
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