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

NCT04334902 | Completed Results

• 1 other identifier: HR-MPD-01
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Diagnoses Disease

Keywords

Neurodegenerative Parkinsonism

Outcome Measures

Primary Outcomes (2)

• Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism

  Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Sensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ \[True positive(TP) + False negative(FN)\] (%)

  At Visit 2 (within 4 weeks after Visit 1)

• Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism

  Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Specificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/\[False positive(FP) + True negative(TN)\] (%)

  At Visit 2 (within 4 weeks after Visit 1)

Study Arms (2)

Abnormal

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

Device: mPDia

Normal

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

Device: mPDia

Interventions

mPDia DEVICE

Clinical decision support system for diagnosing neurodegenerative parkinsonism

Abnormal; Normal

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

(1) Adults over 19 years old (2) 3T nigrosome 1 MRI acquired (3) 18F FP-CIT PET/CT are confirmed to be normal(normal cohort) or abnormal(abnormal cohort)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heuron Inc.: lead

Study Sites (10)

Cha Medical Center

Gyeonggi-do, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

KyungHee University Medical Center

Seoul, South Korea

Location

Results Point of Contact

• Title: Yoomi Kim_Clinical Research Team Leader
• Organization: Heuron

yoomi_kim@iheuron.com

01035173212

Study Officials

• YoungHee Sung, M.D, Ph.D

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: March 13, 2020
• Primary Completion: June 24, 2020
• Study Completion: October 30, 2020
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)