Diagnoses Disease
Conditions
Keywords
Neurodegenerative Parkinsonism
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.
Interventions
DEVICEmPDia
Clinical decision support system for diagnosing neurodegenerative parkinsonism
Sponsors
Heuron Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | At Visit 2 (within 4 weeks after Visit 1) | 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)/ \[True positive(TP) + False negative(FN)\] (%) |
| Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | At Visit 2 (within 4 weeks after Visit 1) | 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)/\[False positive(FP) + True negative(TN)\] (%) |
Countries
South Korea
Participant flow
Recruitment details
The data will be collected retrospectively from person whose past 3T nigrosome 1 MRI image, 18F FP-CIT PET/CT image, image interpretation, and neurologic exam results are confirmed by medical records, and those whose diagnosis as neurodegenerative Parkinsonism is confirmed. Data collecting must be executed following therandom collection. Only the verified researcher who is registered in this study will have access to medical records.
Pre-assignment details
At each Institution, participants who met all inclusion and exclusion criteria for this study were randomly selected up to the target number of participants. Based on the medical record diagnosis of neurodegenerative parkinsonism, participants were classified into the normal group or the patient group. The data from the randomly selected participants were used for diagnostic evaluation.
Participants by arm
| Arm | Count |
|---|---|
| Abnormal The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism | 158 |
| Normal The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism | 60 |
| Total | 218 |
Baseline characteristics
| Characteristic | Total | Normal | Abnormal |
|---|---|---|---|
| Age, Continuous | 66.54 year STANDARD_DEVIATION 9.93 | 68.35 year STANDARD_DEVIATION 8.04 | 65.85 year STANDARD_DEVIATION 10.5 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 119 Participants | 36 Participants | 83 Participants |
| Sex: Female, Male Male | 99 Participants | 24 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Population: Sensitivity is calculated only in the Abnormal group (patients diagnosed with neurodegenerative parkinsonism).~The Normal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abnormal | Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | 94.30 percentage |
Primary
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)
Population: Specificity is calculated only in the Normal group (participants without neurodegenerative parkinsonism).~The Abnormal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal | Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | 91.67 percentage |