Skip to content

Prospective Study for Neuromelanin Image Analysis

Prospective Data Collect Study for Development of Neurimelanin Image Analysis System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05513794
Enrollment
220
Registered
2022-08-24
Start date
2022-11-02
Completion date
2024-07-02
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

Neuromelanin sequence imaging

Sponsors

Heuron Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in Neuromelanin Volume by AgeWithin 1 weeks after enrollmentDescriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age

Secondary

MeasureTime frameDescription
Differences in Neuromelanin Volume by groupWithin 1 weeks after enrollmentDescriptive Statistics for Neuromelanin Volume Measured by MRI Image by group

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026