Diagnoses DiseaseNCT04334902

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

An observational study of Diagnoses Disease, run by Heuron Inc. at 10 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Diagnoses Disease
What is being tested?: mPDia
Type of treatment: Medical device
How many people: 221 participants
Where: 10 sitesSouth Korea
Study dates: 13 Mar 2020to 30 Oct 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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)

Who may be able to join

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
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

Who cannot join

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 locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

South Korea10 sites

Cha Medical Center
Gyeonggi-do
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Hallym University Sacred Heart Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Asan Medical Center
Seoul
Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Gangnam Severance Hospital
Seoul
Korea University Guro Hospital
Seoul
KyungHee University Medical Center
Seoul

Other trials in South Korea

About this study

Official title: An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images

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.

Conditions: Diagnoses Disease
Being tested: mPDia
Keywords: Neurodegenerative Parkinsonism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mPDiaDevice
Clinical decision support system for diagnosing neurodegenerative parkinsonism

Study groups in NCT04334902
Study group	Role	What they receive
Abnormal		The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism Receives: Device: mPDia
Normal		The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism Receives: Device: mPDia

What is being measured

The primary outcome is the main question the study is designed to answer.

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)] (%)
Measured: At Visit 2 (within 4 weeks after Visit 1)
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)] (%)
Measured: At Visit 2 (within 4 weeks after Visit 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202030 Oct 2020

First posted6 Apr 2020
Study start13 Mar 2020
Primary completion24 Jun 2020
Study completion30 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04334902
Sponsor's protocol ID: HR-MPD-01
Status last verified: Sep 2025
First submitted: 2 Apr 2020
Last updated: 29 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
ClinicalTrials.gov ID: NCT04334902
Acronym / sponsor ID: HR-MPD-01
Conditions: Diagnoses Disease
Keywords: Neurodegenerative Parkinsonism
Study type: Observational
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Heuron Inc.Industry (pharma, biotech, devices)
Study start: 13 Mar 2020 (actual)
Primary completion: 24 Jun 2020 (actual)
Study completion: 30 Oct 2020 (actual)
First posted: 6 Apr 2020 (actual)
Results: Posted 29 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Abnormal	–	Device: mPDiaThe person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism
Normal	–	Device: mPDiaThe person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (8 listed)

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
Adults over 19 years old

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mPDiaClinical decision support system for diagnosing neurodegenerative parkinsonism	Device	Abnormal, Normal

Primary outcome

Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism
Time frame: 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
Time frame: 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)] (%)

Results and safety

Results posted to the registry on 29 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abnormal	159	158
Normal	62	60

Primary outcome: Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism

Time frame: At Visit 2 (within 4 weeks after Visit 1). Number (90% Confidence Interval). Unit: percentage

Measure	Abnormal n = 158	Normal n = 0
Value	94.30 (90.69 to 97.92)	–

Population analysed: 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.

Primary outcome: Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism

Time frame: At Visit 2 (within 4 weeks after Visit 1). Number (90% Confidence Interval). Unit: percentage

Measure	Abnormal n = 0	Normal n = 60
Value	–	91.67 (84.67 to 98.66)

Population analysed: 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.

Adverse events

Time frame: Not Applilcable(Retrospective Study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abnormal	0 of 0	0 of 0	0
Normal	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

YoungHee Sung, M.D, Ph.D principal investigator

Gachon University Gil Medical Center

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diagnoses Disease, run by Heuron Inc. at 10 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism (time frame: At Visit 2 (within 4 weeks after Visit 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04334902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.