Prospective Study for Neuromelanin Image Analysis

Not Applicable

• Conditions: Parkinson Disease

• 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

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Study Start: 2022-11-02
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-08
• Study Completion: 2023-12

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

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