Vascular ParkinsonismNCT06949865
AI-Enhanced Optimization of Acute Levodopa Challenge Test
An observational study of Vascular Parkinsonism and Drug-induced Parkinsonism, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
A quantitative evaluation method was developed for Parkinson's disease and other atypical parkinonism by integrating an innovative motor paradigm with perception technologies and artificial intelligence. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Vascular Parkinsonism, Drug-induced Parkinsonism, Corticobasal Degeneration (CBD)
- What is being tested?
- video recording
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, participants are recruited from the multicenters across China. Participants are enrolled through outpatient assessment and screening.
Who may be able to join
- Parkinson's disease (PD) group: 1. Patients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria; 2. Patients with early-stage PD meet the Hoehn-Yahr score ≤ 2.5 points, and patients with intermediate and advanced PD meet the Hoehn-Yahr score of 2.5-5 points; 3. Subjects are 50-75 years old (including boundary values), gender is not limited; 4. Agree to undergo study-related examination evaluation and sign informed consent.
- Multiple system atrophy (MSA) group : 1. Patients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022 ;2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Progressive supranuclear palsy (PSP) group: 1. Patients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Vascular parkinsonism (VP) group: 1. In line with the diagnostic recommendations of vascular parkinsonism in accordance with the 2004 International Association for Movement Disorders and the 2017 Chinese expert consensus; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Drug-induced parkinsonism (DIP) group: 1. Parkinsonism; 2. Drug history, the appearance of symptoms is related to specific drugs; 3. Symptoms are reversible, and the symptoms are reduced or disappeared when the corresponding drugs are reduced; 4. Rule out other causes; 5. Subjects are 50-75 years old (including boundary values), gender is not limited; 6. Agree to undergo study-related examination evaluation and sign informed consent.
- Corticobasal degeneration (CBD) group: 1. Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Dementia with Lewy Bodies (DLB) Group: 1. Diagnosed as probable or possible DLB based on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLB diagnostic criteria. 2. Exhibits symptoms of Parkinsonism. 3. Subjects are aged 50-75 years (inclusive), with no gender restriction. 4. Agree to undergo study-related assessments and evaluations and signs the informed consent form.
Who cannot join
- Cognitive dysfunction, unable to complete the study (MMSE < 23)
- Inability to tolerate levodopa shock test
- Patients with failure of important organs (heart, lung, liver, kidney, etc.), malignant tumors, unstable conditions and other serious internal diseases
- Those with serious behavioral problems or mental disorders
- Inability to sign informed consent
- Other conditions that are considered unsuitable by the investigator to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Affiliated to Capital Medical University
Beijing, 100070
Dr. Ling-yan Ma, 86-13520873987, Jennifer_MLY@163.com
About this study
Official title: Clinical Research on Optimization of Acute Levodopa Challenge Test and Exploration of New Motor Paradigm Based on the Integration of Perception Technology and Artificial Intelligence
A quantitative evaluation method was developed for Parkinson's disease and other atypical parkinonism by integrating an innovative motor paradigm with perception technologies and artificial intelligence. Combined with traditional motor paradigms and the acute levodopa challenge test, this study aims to identify diagnostic cut-off values for PD and other atypical parkinonism, explore digital biomarkers for early and differential diagnosis, and establish a corresponding diagnostic model.
- Conditions
- Vascular Parkinsonism, Drug-induced Parkinsonism, Corticobasal Degeneration (CBD), Parkinson Disease (PD), Dementia With Lewy Body Disease, Progressive Supranuclear Palsy(PSP)
- Being tested
- video recording
- Medical subject headings
- Corticobasal Degeneration, Parkinson Disease, Supranuclear Palsy, Progressive, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video recordingOther
The patient's motor symptoms were recorded via video for assessment purposes.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease (PD) group: | Patients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria. Receives: Other: video recording | |
| Multiple system atrophy (MSA) group | Patients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022. Receives: Other: video recording | |
| Progressive supranuclear palsy (PSP) group | Patients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group. Receives: Other: video recording | |
| Vascular parkinsonism (VP) group | In line with the diagnostic recommendations of vascular parkinsonism in accordance with the 2004 International Association for Movement Disorders and the 2017 Chinese expert consensus. Receives: Other: video recording | |
| Drug-induced parkinsonism (DIP) group | Parkinsonism. Receives: Other: video recording | |
| Corticobasal degeneration (CBD) group | Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration. Receives: Other: video recording | |
| Dementia with Lewy Bodies (DLB) Group | Diagnosed as probable or possible DLB based on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLB diagnostic criteria. Receives: Other: video recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The test correctly identified the total proportion of individuals with and without the disease.
Measured: baseline
Diagnostic Odds Ratio
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The ratio of positive likelihood ratio to negative likelihood ratio reflects the diagnostic efficiency of the test.
Measured: baseline
Specificity
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of healthy people without a certain disease correctly identified by a diagnostic test. High specificity means that the test rarely misdiagnoses healthy people as disease patients (i.e., low false positive rate).
Measured: baseline
Negative Predictive Value
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Among all individuals who tested negative, the proportion who were truly free of the disease.
Measured: baseline
Sensitivity
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of patients with a disease correctly identified by a diagnostic test. High sensitivity means that the test rarely misses cases of disease (i.e., low false negative rate).
Measured: baseline
Positive Predictive Value
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Of all the individuals who tested positive, the proportion who actually had the disease.
Measured: baseline
Secondary outcomes (10)
Negative Predictive Value
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Among all individuals who test negative, the proportion who are truly free of the disease.
Measured: baseline
root mean square error
Quantify the magnitude of the prediction error
Measured: baseline
Correlation Coefficient
Strength of the linear relationship between reflection and true results
Measured: baseline
Specificity
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Diagnostic tests correctly identify the proportion of healthy people who do not have a disease.
Measured: baseline
Sensitivity
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Refers to the proportion of patients with a disease that a diagnostic test correctly identifies.
Measured: baseline
Positive Predictive Value
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Of all the individuals who tested positive, the proportion who actually had the disease
Measured: baseline
Coefficient of Determination
The proportion of variation that reflects the interpretation of the results
Measured: baseline
Diagnostic Odds Ratio
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.The ratio of positive likelihood ratio to negative likelihood ratio reflects the diagnostic efficiency of the test.
Measured: baseline
Accuracy
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.The total proportion of individuals with and without the disease correctly identified by the test
Measured: baseline
Intraclass Correlation Coefficient
Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Consistency and reliability of evaluation results
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start28 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ParkinsonismStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Nanjing Medical University, Second Affiliated Hospital of Soochow University, Beijing Hospital, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, West China Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, Renmin Hospital of Wuhan University, First Affiliated Hospital of Chongqing Medical University, Second Affiliated Hospital of Nanchang University, Xijing Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Xinjiang Medical University, Shenzhen People's Hospital, Tianjin Medical University General Hospital, Qilu Hospital of Shandong University, The First People's Hospital of Yunnan, The First Hospital of Jilin University, Tianjin Huanhu Hospital, The First Affiliated Hospital of Anhui Medical University, Wannan Medical College Yijishan Hospital, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949865
- Sponsor's protocol ID
- HX-A-2024018
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Optimization of Acute Levodopa Challenge Test and Exploration of New Motor Paradigm Based on the Integration of Perception Technology and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06949865
- Acronym / sponsor ID
- HX-A-2024018
- Conditions
- Vascular Parkinsonism, Drug-induced Parkinsonism, Corticobasal Degeneration (CBD), Parkinson Disease (PD), Dementia With Lewy Body Disease, Progressive Supranuclear Palsy(PSP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Nanjing Medical University, Second Affiliated Hospital of Soochow University, Beijing Hospital, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, West China Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, Renmin Hospital of Wuhan University, First Affiliated Hospital of Chongqing Medical University, Second Affiliated Hospital of Nanchang University, Xijing Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Xinjiang Medical University, Shenzhen People's Hospital, Tianjin Medical University General Hospital, Qilu Hospital of Shandong University, The First People's Hospital of Yunnan, The First Hospital of Jilin University, Tianjin Huanhu Hospital, The First Affiliated Hospital of Anhui Medical University, Wannan Medical College Yijishan Hospital, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A quantitative evaluation method was developed for Parkinson's disease and other atypical parkinonism by integrating an innovative motor paradigm with perception technologies and artificial intelligence. Combined with traditional motor paradigms and the acute levodopa challenge test, this study aims to identify diagnostic cut-off values for PD and other atypical parkinonism, explore digital biomarkers for early and differential diagnosis, and establish a corresponding diagnostic model.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease (PD) group: | – | Other: video recordingPatients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria. |
| Multiple system atrophy (MSA) group | – | Other: video recordingPatients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022. |
| Progressive supranuclear palsy (PSP) group | – | Other: video recordingPatients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group. |
| Vascular parkinsonism (VP) group | – | Other: video recordingIn line with the diagnostic recommendations of vascular parkinsonism in accordance with the 2004 International Association for Movement Disorders and the 2017 Chinese expert consensus. |
| Drug-induced parkinsonism (DIP) group | – | Other: video recordingParkinsonism. |
| Corticobasal degeneration (CBD) group | – | Other: video recordingDiagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration. |
| Dementia with Lewy Bodies (DLB) Group | – | Other: video recordingDiagnosed as probable or possible DLB based on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLB diagnostic criteria. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, participants are recruited from the multicenters across China. Participants are enrolled through outpatient assessment and screening.
Key inclusion criteria (7 listed)
- Parkinson's disease (PD) group: 1. Patients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria; 2. Patients with early-stage PD meet the Hoehn-Yahr score ≤ 2.5 points, and patients with intermediate and advanced PD meet the Hoehn-Yahr score of 2.5-5 points; 3. Subjects are 50-75 years old (including boundary values), gender is not limited; 4. Agree to undergo study-related examination evaluation and sign informed consent.
- Multiple system atrophy (MSA) group : 1. Patients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022 ;2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Progressive supranuclear palsy (PSP) group: 1. Patients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Vascular parkinsonism (VP) group: 1. In line with the diagnostic recommendations of vascular parkinsonism in accordance with the 2004 International Association for Movement Disorders and the 2017 Chinese expert consensus; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent.
- Drug-induced parkinsonism (DIP) group: 1. Parkinsonism; 2. Drug history, the appearance of symptoms is related to specific drugs; 3. Symptoms are reversible, and the symptoms are reduced or disappeared when the corresponding drugs are reduced; 4. Rule out other causes; 5. Subjects are 50-75 years old (including boundary values), gender is not limited; 6. Agree to undergo study-related examination evaluation and sign informed consent.
Key exclusion criteria (6 listed)
- Cognitive dysfunction, unable to complete the study (MMSE < 23)
- Inability to tolerate levodopa shock test
- Patients with failure of important organs (heart, lung, liver, kidney, etc.), malignant tumors, unstable conditions and other serious internal diseases
- Those with serious behavioral problems or mental disorders
- Inability to sign informed consent
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 |
|---|---|---|
| video recordingThe patient's motor symptoms were recorded via video for assessment purposes. | Other | Corticobasal degeneration (CBD) group, Dementia with Lewy Bodies (DLB) Group, Drug-induced parkinsonism (DIP) group, Multiple system atrophy (MSA) group, Parkinson's disease (PD) group:, Progressive supranuclear palsy (PSP) group, Vascular parkinsonism (VP) group |
Primary outcome
Accuracy
Time frame: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The test correctly identified the total proportion of individuals with and without the disease.
Diagnostic Odds Ratio
Time frame: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The ratio of positive likelihood ratio to negative likelihood ratio reflects the diagnostic efficiency of the test.
Specificity
Time frame: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of healthy people without a certain disease correctly identified by a diagnostic test. High specificity means that the test rarely misdiagnoses healthy people as disease patients (i.e., low false positive rate).
Negative Predictive Value
Time frame: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Among all individuals who tested negative, the proportion who were truly free of the disease.
Sensitivity
Time frame: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of patients with a disease correctly identified by a diagnostic test. High sensitivity means that the test rarely misses cases of disease (i.e., low false negative rate).
Positive Predictive Value
Time frame: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Of all the individuals who tested positive, the proportion who actually had the disease.
10 secondary outcomes
Negative Predictive Value
Time frame: baseline
root mean square error
Time frame: baseline
Correlation Coefficient
Time frame: baseline
Specificity
Time frame: baseline
Sensitivity
Time frame: baseline
Positive Predictive Value
Time frame: baseline
Coefficient of Determination
Time frame: baseline
Diagnostic Odds Ratio
Time frame: baseline
Accuracy
Time frame: baseline
Intraclass Correlation Coefficient
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Parkinsonism and Drug-induced Parkinsonism, run by Beijing Tiantan Hospital at 1 site in China.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Feng, MD (86-13911125339, bxbkyjs@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2025.