N/A
N=221
Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
Diagnoses Disease
Bottom Line
View on ClinicalTrials.gov: NCT04334902 ↗Enrolled (actual)
221
Serious AEs
—
Results posted
Oct 2025
Primary outcome: Primary: Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism — 94.30 percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- mPDia (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Heuron Inc.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism |
94.30 | — |
| PRIMARY Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism |
91.67 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04334902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.