Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
- Conditions
- Diagnoses Disease
- Interventions
- Device: mPDia
- Registration Number
- NCT04334902
- Lead Sponsor
- Heuron Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
Not provided
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Normal mPDia The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism Abnormal mPDia The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of mPDia Within 4 weeks after collecting data Sensitivity and specificity of mPDia in diagnosis of neurodegenerative parkinsonism based on golden standards
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Cha Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Medical Center
🇰🇷Seoul, Korea, Republic of