Blood-based predictors of DBS outcomes for Parkinson's disease
A Prospective Observational Study for the Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease
This project will test whether proteins and RNA in blood can predict how people with Parkinson's disease will respond to deep brain stimulation (DBS).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hong Kong University of Science and Technology Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07376278 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study collecting blood samples and routinely discarded brain tissue from patients undergoing DBS for Parkinson's disease, without changing the surgical procedure. Investigators will measure proteomic, transcriptomic, and genomic markers and link them to clinical outcomes including motor, axial, non-motor symptoms, medication changes, activities of daily living, and quality of life. Samples and clinical data will be compared before and after DBS to identify markers associated with good versus poor response and to track longitudinal changes. The team will combine multiomic profiles with clinical features to build an explainable AI model to predict and stratify DBS response.
Who should consider this trial
Good fit: People with clinically established Parkinson's disease referred for DBS who are dopamine-responsive, generally age 75 or younger, and without major psychiatric, cognitive, or surgical contraindications are ideal candidates.
Not a fit: Patients with atypical parkinsonism or heavy-metal–related parkinsonism, those with significant cognitive or psychiatric problems, those with surgical contraindications, or those unwilling to provide blood samples are unlikely to benefit from the study's predictive testing.
Why it matters
Potential benefit: If successful, the work could help identify who is most likely to benefit from DBS and guide personalized treatment decisions to improve outcomes.
How similar studies have performed: While multiomic biomarker research in Parkinson's exists, using blood and leftover surgical tissue specifically to predict DBS response is largely novel and has limited prior evidence of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of "Clinically Established PD" as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (MDS-PD criteria) 2. Referred for DBS according to standard local clinical guidelines 2a. Significant motor complications despite optimized pharmacological treatment 2ai. UPDRS motor score \>30/108 in the off-medication state 2aii. Hoehn and Yahr staging \>2.5/5 in the off-medication state 2b. Dopamine responsive 2bi. \>33% improvement in UPDRS motor score after levodopa administration 2c. Age ≤75 years 2d. No contraindication to surgery or other significant comorbidity with limited life expectancy 2e. No significant psychiatric problems or cognitive impairment 2f. No structural lesions or features suggestive of atypical parkinsonism or other mimickers of idiopathic PD on neuroimaging Exclusion Criteria: 1. Unwilling to undergo blood sampling for study purposes 2. Evidence of Parkinsonism due to heavy metal exposure 3. History of neurodevelopmental disorder, neurodegenerative disease other than PD, CNS infection, neuroinflammatory disease (e.g. multiple sclerosis, CNS lupus), malignancy within the last 10 years, cerebrovascular accident, HIV infection, systemic autoimmune disease, alcohol dependence or other substance use 4. Unable to pass DBS pre-operative assessment or unwilling to undergo DBS
Where this trial is running
Hong Kong
- The Hong Kong University of Science and Technology — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Nancy Ip — The Hong Kong University of Science and Technology
- Study coordinator: Nancy Ip
- Email: boip@ust.hk
- Phone: 852-23587304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.