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

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 Overview

• Status: Completed
• Conditions: Diagnoses Disease
• Intervention / Treatment: Device: mPDia

• Study Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Korea University Ansan Hospital
  • Gyeonggi-do, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Gyeonggi-do, Korea, Republic of
    • CHA Medical Center
  • Gyeonggi-do, Korea, Republic of
    • Hallym University Dongtan Sacred Heart Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abnormal; The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism	Device: mPDia; Clinical decision support system for diagnosing neurodegenerative parkinsonism
Normal; The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism	Device: mPDia; Clinical decision support system for diagnosing neurodegenerative parkinsonism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of mPDia	Sensitivity and specificity of mPDia in diagnosis of neurodegenerative parkinsonism based on golden standards	Within 4 weeks after collecting data

Collaborators and Investigators

• Sponsor: Heuron Inc.
• Investigators: Principal Investigator: YoungHee Sung, M.D, Ph.D, Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): June 24, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Neurodegenerative Parkinsonism
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Parkinsonian Disorders
• Other Study ID Numbers: HR-MPD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No