Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images

NCT ID: NCT04334902

Last Updated: 2025-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2020-10-30

Brief Summary

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mPDia is a software that has been pre-learned based on a neurodegenerative parkinsonism diagnosis model using Nigrosome 1 MRI images, and clinical decision support system for diagnosing neurodegenerative parkinsonism by automatically analyzing Nigrosome 1 MRI images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of mPDia for neurodegenerative Parkinsonism compared to the sensitivity and specificity levels of 18F FP-CIT PET/CT which is currently used to diagnose neurodegenerative parkinsonism.

Detailed Description

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Conditions

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Diagnoses Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Abnormal

The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism

mPDia

Intervention Type DEVICE

Clinical decision support system for diagnosing neurodegenerative parkinsonism

Normal

The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism

mPDia

Intervention Type DEVICE

Clinical decision support system for diagnosing neurodegenerative parkinsonism

Interventions

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mPDia

Clinical decision support system for diagnosing neurodegenerative parkinsonism

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults over 19 years old
* 3T nigrosome 1 MRI acquired
* 18F FP-CIT PET/CT are confirmed to be normal
* The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism


* Adults over 19 years old
* 3T nigrosome 1 MRI acquired
* 18F FP-CIT PET/CT are confirmed to be abnormal
* The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism

Exclusion Criteria

* Patients with other brain diseases except parkinsonism
* Who have anatomical abnormality in MRIs etc.
* Who have other causes of tremor(e.g., thyroid disease)
* Patients with lesion in basal ganglia(e.g., vascular parkinsonism, hydrocephalus and Wilson's disease)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heuron Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YoungHee Sung, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

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Cha Medical Center

Gyeonggi-do, , South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Gyeonggi-do, , South Korea

Site Status

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

KyungHee University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HR-MPD-01

Identifier Type: -

Identifier Source: org_study_id

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