Prospective Study for Neuromelanin Image Analysis
Not Applicable
- Conditions
- Parkinson Disease
- Interventions
- Device: MRI Imaging
- Registration Number
- NCT05513794
- Lead Sponsor
- Heuron Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 220
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient group MRI Imaging Patient with parkinson disease Healthy volunteer group MRI Imaging Healthy volunteer
- Primary Outcome Measures
Name Time Method Differences in Neuromelanin Volume by Age Within 1 weeks after enrollment Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
- Secondary Outcome Measures
Name Time Method Differences in Neuromelanin Volume by group Within 1 weeks after enrollment Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group
Trial Locations
- Locations (3)
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Nowon-gu, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seodaemun Gu, Korea, Republic of
Yong-in Severance Hospital, Yonsei University Health System
🇰🇷Gyeonggi-do, Yongin-si, Korea, Republic of