Skip to content

Development of a Multimodal Diagnostic Evaluation System for Parkinson's Disease

Development of a Multimodal Diagnostic Evaluation System for Parkinson's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115159
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Parkinson‘s disease

Interventions

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Basic Inclusion Criteria: (1) Ability to sign a written informed consent form: The subject and/or their legally authorized representative (in cases of reduced decision-making capacity), in compliance with national laws, must be able to read, understand, and provide written informed consent. (2) Ability to complete assessments independently or with the assistance of a companion. (3) Willingness and capability to fulfill all study requirements (e.g., peripheral organ function evaluations, PET imaging for some patients, etc.). (4) Age between 45 and 95 years. 2. Normal Control Group Inclusion Criteria: (1) Similar age distribution and gender ratio to the Parkinson's disease (PD) group. (2) Non-Parkinson’s individuals from ophthalmology clinics, health examination centers, community settings, and some neurology clinic patients (e.g., those with tension-type headache or diabetic peripheral neuropathy), confirmed by a negative DaTscan result indicating no nigrostriatal impairment. 3. Parkinson's Disease Group Inclusion Criteria: Meet the clinical diagnostic criteria for Parkinson’s disease as established by the International Movement Disorder Society (MDS) in 2015.

Exclusion criteria

Exclusion criteria: (1) Refusal to sign the informed consent form; (2) Inability to cooperate with the completion of relevant scale assessments; (3) Presence of end-stage major systemic diseases (e.g., malignant tumors or autoimmune diseases) at the time of enrollment; (4) Psychiatric disorders (e.g., depression, schizophrenia); (5) Severe systemic diseases (e.g., diabetic retinopathy, autoimmune disorders, end-stage malignancies); (6) Ocular diseases that may affect OCT results (e.g., glaucoma, macular degeneration, high myopia exceeding -6.00 diopters, severe cataracts); (7) History of neurological disorders relevant to PD pathology (e.g., multiple sclerosis, Alzheimer's disease, stroke, epilepsy).

Design outcomes

Secondary

MeasureTime frame
Positive Likelihood Ratio/Negative Likelihood Ratio/Diagnostic Odds Ratio;Calibration;Sensitivity/Specificity/Negative Predictive Value/Positive Predictive Value;Area Under the Curve;

Countries

China

Contacts

Public ContactYang Zhang

The First Affiliated Hospital of Wenzhou Medical University

zhangyang@wzhospital.cn+86 152 5808 7590

Outcome results

None listed

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