ClinicalTrials.gov record NCT06949865

AI-Enhanced Optimization of Acute Levodopa Challenge Test

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age50 years old to 75 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study uses perception technology and artificial intelligence to analyze motor recordings during standard tests and an acute levodopa challenge. It is for people with Parkinson disease or other parkinsonian syndromes and seeks diagnostic cut-offs and digital biomarkers. Participants undergo motor assessments and video recording; researchers analyze the data to evaluate diagnostic accuracy.

What it is studying. Whether quantitative motor measurements captured by perception technology and analyzed with AI, together with the acute levodopa challenge and conventional motor tests, can identify diagnostic cut-off values and digital biomarkers to distinguish Parkinson disease from other parkinsonian syndromes.

What the researchers hope to learn. Identify diagnostic cut-off values for PD and atypical parkinsonism; explore digital biomarkers for early and differential diagnosis; establish a diagnostic model that integrates perception technology and artificial intelligence.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • video recording

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join you will sign informed consent and undergo study-related examinations and evaluations. Typical study activities include motor assessments with video recording of symptoms and an acute levodopa challenge (levodopa “shock”) test; a brief cognitive screen (MMSE) may be done for eligibility. The study uses these measurements and recordings for diagnostic research and model building. Specific visit schedules and other assessments are not detailed in the registry record.

How the study is structured. An observational, cross-sectional cohort study. Participants have motor assessments and video recording during standard testing and an acute levodopa challenge; collected data are analyzed with AI and perception technology to evaluate diagnostic measures. No investigational treatment is assigned by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on progressive supranuclear palsy

This trial is also listed on this site under multiple system atrophy.

Clinical trials45 trials listed for progressive supranuclear palsyEvery trial the registry lists for progressive supranuclear palsy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in progressive supranuclear palsy researchLatest monthly update: September 2026. Includes: PSP vs Parkinsons. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 28, 2024
Primary completion
Dec 31, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
2000 participants (estimated)
Last updated on registry
Apr 29, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Beijing Tiantan Hospital
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

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials