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OpenTrials
Completed

NCT Number: NCT05513794

Prospective Study for Neuromelanin Image Analysis

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University Health System, Seoul, Seodaemun gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

MRI imaging

Device

Neuromelanin sequence imaging

Primary outcomes

  1. Differences in Neuromelanin Volume by Age

    Time frame: Within 1 weeks after enrollment

    Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age

Secondary outcomes

  1. Differences in Neuromelanin Volume by group

    Time frame: Within 1 weeks after enrollment

    Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group

Sponsors and collaborators

Lead sponsor

Heuron Inc.

Industry

Registry information

Official study title

Prospective Data Collect Study for Development of Neurimelanin Image Analysis System

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 24, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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