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

An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images

NCT04334902•Heuron Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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)

Locations (10)

Cha Medical Center

Gyeonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Hallym University Sacred Heart Hospital

Gyeonggi-do, South Korea

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Asan Medical Center

Seoul, South Korea

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

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

KyungHee University Medical Center

Seoul, South Korea

Key Dates

Start Date

March 13, 2020

Primary Completion Date

June 24, 2020

Completion Date

October 30, 2020

Last Updated

October 29, 2025

Enrollment

221

ACTUAL participants

Conditions

Diagnoses Disease

Interventions

mPDia

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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