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

Heuron Inc.221 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

221

Conditions

Diagnoses Disease

Interventions

mPDiaDEVICE

Clinical decision support system for diagnosing neurodegenerative parkinsonism

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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)/ \[True positive(TP) + False negative(FN)\] (%)

Time frame: 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)/\[False positive(FP) + True negative(TN)\] (%)

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

Data from ClinicalTrials.gov

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