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

H

Heuron

Status

Completed

Conditions

Diagnoses Disease

Treatments

Device: mPDia

Study type

Observational

Funder types

Industry

Identifiers

NCT04334902
HR-MPD-01

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

221 participants in 2 patient groups

Abnormal
Description:
The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
Treatment:
Device: mPDia
Normal
Description:
The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism
Treatment:
Device: mPDia

Trial documents
1

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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