Prospective Study for Neuromelanin Image Analysis

Parkinson Disease Clinical Trial

Official title:

Prospective Data Collect Study for Development of Neurimelanin Image Analysis System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513794
• Other study ID #: qMT-PD-02
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Heuron Inc.
• Contact: Yoomi Kim
• Phone: +82 032-429-8503
• Email: yoomi_kim[@]iheuron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• MRI Imaging
Neuromelanin sequence imaging

Locations

Country	Name	City	State
Korea, Republic of	Yong-in Severance Hospital, Yonsei University Health System	Gyeonggi-do	Yongin-si
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul	Nowon-gu
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun Gu

Sponsors (1)

Lead Sponsor	Collaborator
Heuron Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Neuromelanin Volume by Age	Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age	Within 1 weeks after enrollment
Secondary	Differences in Neuromelanin Volume by group	Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group	Within 1 weeks after enrollment