Clinical trial NCT05513794: Prospective Study for Neuromelanin Image Analysis
Official title: Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Heuron Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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;

Primary outcomes:
measure: Differences in Neuromelanin Volume by Age
timeFrame: Within 1 weeks after enrollment
Secondary outcomes:
measure: Differences in Neuromelanin Volume by group
timeFrame: Within 1 weeks after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
state: Nowon-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seodaemun Gu
city: Gyeonggi-do
country: Korea, Republic of
facility: Yong-in Severance Hospital, Yonsei University Health System
state: Yongin-si
Study officials:
affiliation: Severance Hospital, Yonsei University Health System
name: Phil Hyu Lee, M.D.pH.D
role: PRINCIPAL_INVESTIGATOR
References: