Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHong Kong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Parkinson's disease patients of the movement disorder clinic at Queen Elizabeth Hospital Hong Kong
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
DBS
Procedure/SurgeryDeep brain stimulation surgery
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment1 intervention
Trial outcomes
Primary outcomes
1
Blood proteomic profile
Plasma proteins measured using high-throughput ultra-sensitive proteomics platform
Time frame
From pre-operative to 5 years post-operative2
Blood transcriptomic profile
Bulk RNA-sequencing of blood cells
Time frame
From pre-operative to 5 years post-operative3
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Rating scale that measures non-motor experiences of daily living (part I), motor experiences of daily living (part II), motor function via physical examination (part III), and motor complications (part IV) Higher scores indicate a worse outcome Range: Part I: 0-52 Part II: 0-52 Part III: 0-132 Part IV: 0-24
Time frame
From pre-operative to 5 years post-operative4
Hoehn and Yahr (H&Y) stage
Staging of overall functional disability in Parkinson's disease Higher score indicates a worse outcome Range: 0-5 Stage 0: No signs of disease Stage 1: Unilateral disease Stage 1.5: Unilateral plus axial involvement Stage 2: Bilateral disease without impairment of balance Stage 2.5: Mild bilateral disease with recovery on pull test Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent Stage 4: Severe disability; still able to walk / stand unassisted Stage 5: Wheelchair bound or bedridden unless aided
Time frame
From pre-operative to 5 years post-operativeSecondary outcomes
1
Montreal Cognitive Assessment (MoCA)
Assessment of cognitive function in 8 domains: attention and concentration, executive functions, memory, language, visuospatial skills, abstraction, calculations, and orientation Higher score indicates a better outcome Range: 0-30
Time frame
From pre-operative to 5 years post-operative2
Non-Motor Symptoms Scale (NMSS)
Assessment of symptomatic burden of non-motor symptoms Higher score indicates a worse outcome Range: 0-360
Time frame
From pre-operative to 5 years post-operative3
Parkinson's Disease Sleep Scale - 2 (PDSS-2)
Rating scale assessing sleep disorders in PD Higher score indicates a worse outcome Range: 0-60
Time frame
From pre-operative to 5 years post-operative4
Parkinson's Disease Questionnaire - 39 (PDQ-39)
39-item self-report questionnaire assessing health-related quality of life in 8 domains: mobility, activities of daily living, emotional wellbeing, stigma, social support, cognition, communication, and bodily discomfort Higher score indicates a worse outcome Range: 0-100
Time frame
From pre-operative to 5 years post-operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hong Kong University of Science and Technology
Lead sponsor
Queen Elizabeth Hospital, Hong Kong
Collaborator
Hong Kong Center for Neurodegenerative Diseases
Collaborator
Source ClinicalTrials.gov