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OpenTrials
Completed

NCT Number: NCT04334902

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

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.

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Key information

Conditions

Diagnoses Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cha Medical Center, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Normal cohort):

  • 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

Inclusion criteria

(Abnormal cohort):

  • 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)

Treatment and study plan

mPDia

Device

Clinical decision support system for diagnosing neurodegenerative parkinsonism

Primary outcomes

  1. Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism

    Time frame: At Visit 2 (within 4 weeks after Visit 1)

    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)] (%)

  2. Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism

    Time frame: At Visit 2 (within 4 weeks after Visit 1)

    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)] (%)

Sponsors and collaborators

Lead sponsor

Heuron Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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