NCT05513794CompletedNot Applicable
Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heuron Inc.
- Enrollment
- 220
- Locations
- 6
- Primary Endpoint
- Differences in Neuromelanin Volume by Age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Outcomes
Primary Outcomes
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
- Differences in Neuromelanin Volume by group(Within 1 weeks after enrollment)
Investigators
Study Sites (6)
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