Prospective Study for Neuromelanin Image Analysis

NCT ID: NCT05513794

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2024-07-02

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient group

Patient with parkinson disease

Group Type: EXPERIMENTAL

MRI Imaging

Intervention Type: DEVICE

Neuromelanin sequence imaging

Healthy volunteer group

Healthy volunteer

Group Type: EXPERIMENTAL

MRI Imaging

Intervention Type: DEVICE

Neuromelanin sequence imaging

Interventions

MRI Imaging

Neuromelanin sequence imaging

Intervention Type: DEVICE

Eligibility Criteria

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

• 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 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

• 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;

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heuron Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phil Hyu Lee, M.D.pH.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yonsei University Health System

Locations

Inje University Sanggye Paik Hospital

Seoul, nowon-gu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun gu, South Korea

Yong-in Severance Hospital, Yonsei University Health System

Gyeonggi-do, yongin-si, South Korea

Countries

South Korea

Other Identifiers

qMT-PD-02

Identifier Type: -

Identifier Source: org_study_id