Prospective Study for Neuromelanin Image Analysis

Heuron

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: MRI Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT05513794

qMT-PD-02

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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;

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Patient group

Experimental group

Description:

Patient with parkinson disease

Treatment:

Device: MRI Imaging

Healthy volunteer group

Experimental group

Description:

Healthy volunteer

Treatment:

Device: MRI Imaging