Prospective Study for Neuromelanin Image Analysis

Sponsor
Heuron Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513794
Collaborator
(none)
220
3
2
15
73.3
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI Imaging
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient group

Patient with parkinson disease

Device: MRI Imaging
Neuromelanin sequence imaging

Experimental: Healthy volunteer group

Healthy volunteer

Device: MRI Imaging
Neuromelanin sequence imaging

Outcome Measures

Primary Outcome Measures

  1. Differences in Neuromelanin Volume by Age [Within 1 weeks after enrollment]

    Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age

Secondary Outcome Measures

  1. Differences in Neuromelanin Volume by group [Within 1 weeks after enrollment]

    Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inje University Sanggye Paik Hospital Seoul Nowon-gu Korea, Republic of 01757
2 Severance Hospital, Yonsei University Health System Seoul Seodaemun Gu Korea, Republic of 03722
3 Yong-in Severance Hospital, Yonsei University Health System Gyeonggi-do Yongin-si Korea, Republic of 16995

Sponsors and Collaborators

  • Heuron Inc.

Investigators

  • Principal Investigator: PhilHeu Lee, M.D.pH.D, Severance Hospital, Yonsei University Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heuron Inc.
ClinicalTrials.gov Identifier:
NCT05513794
Other Study ID Numbers:
  • qMT-PD-02
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022