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A prospective clinical study on the evaluation of levodopa challenge test based on fusion sensing technology and artificial intelligence for the diagnosis of Parkinson's syndrome.

A prospective clinical study on the evaluation of levodopa challenge test based on fusion sensing technology and artificial intelligence for the diagnosis of Parkinson's syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112337
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease.

Interventions

Gold Standard:Comprehensive Diagnostic Conclusion from Multiple Experts Based on Various Diagnostic Criteria.
Index test:Based on a quantitative evaluation method that incorporates innovative action paradigms, fusion perception, and artificial intelligence, combined with the levodopa shock test

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with clinically established Parkinsonian syndrome according to the 2015 International Movement Disorder Society (MDS) diagnostic criteria for Parkinson's disease; 2. Newly diagnosed (disease duration <3 years) with no prior standardized levodopa therapy; 3. Aged 18–80 years (inclusive), regardless of gender; 4. Willing to undergo study-related evaluations and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cognitive impairment making assessment difficult; 2. Unable to undergo levodopa challenge test; 3. Severe organ failure (heart, lung, liver, kidney, etc.), malignant tumors, unstable conditions, or other serious medical issues; 4. Severe behavioral or mental disorders; 5. Unable to consent to the study; 6. Other situations where the investigator deems participation unsuitable.

Design outcomes

Primary

MeasureTime frame
Negative Predictive Value for early diagnosis;Specificity for early diagnosis;Accuracy for early diagnosis;Sensitivity for early diagnosis;Positive Predictive Value for early diagnosis;Diagnostic Odds Ratio for early diagnosis;

Secondary

MeasureTime frame
Positive Predictive Value for differential diagnosis;Negative Predictive Value for differential diagnosis;Accuracy for differential diagnosis;Specificity for differential diagnosis;Sensitivity for differential diagnosis;Diagnostic Odds Ratio for differential diagnosis;

Countries

China

Contacts

Public ContactTao Feng

Beijing Tiantan Hospital, Capital Medical University

happyft@sina.com+86 13911125339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026