Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease
Recruiting · NCT07376278 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hong Kong University of Science and Technology
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this observational study is to identify factors in blood that are associated with response to deep brain stimulation (DBS) surgery in patients with Parkinson's disease. The main questions it aims to answer are: 1. What factors in blood (proteins and RNA) are associated with good vs poor response to DBS? 2. Are these factors able to predict response to DBS? 3. How do these factors change before and after DBS? Blood and leftover brain tissue (which spontaneously adhere to the surgical instruments) will be taken and routine clinical data (including scores from routine assessments) will be collected from consenting participants who undergo DBS.
Who can take part
Inclusion criteria
- Diagnosis of "Clinically Established PD" as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (MDS-PD criteria)
- 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
- Unwilling to undergo blood sampling for study purposes
- Evidence of Parkinsonism due to heavy metal exposure
- 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
- Unable to pass DBS pre-operative assessment or unwilling to undergo DBS
Where it is running
1 location listed.
- The Hong Kong University of Science and Technology - Hong Kong, Hong Kong