Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease

A Prospective Observational Study for the Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Brain Stimulation; PARKINSON DISEASE (Disorder)
• Intervention / Treatment: Procedure: DBS

Detailed Description

This is a prospective observational study that investigates the clinical, proteomic, transcriptomic, and genomic profiles that are associated with DBS response with regards to motor symptoms, axial symptoms, non-motor symptoms, change in medications, activities of daily living (ADLs), and quality of life (QOL). The investigators will take blood samples from participants but will not take extra brain tissue; only leftover brain tissue (which is routinely discarded) that spontaneously adheres to surgical instruments will be collected. Study participation will not change the surgical procedure in any way. The investigators also aim to characterize the change in these multiomic profiles before versus after DBS treatment, to evaluate the ability of these multiomic profiles to predict and stratify response to DBS, and to identify modifiable factors to improve response to DBS. Additionally, the investigators will use these multiomic profiles, patient demographics, and clinical presentation to develop a DBS prediction model with advanced explainable AI (XAI) techniques.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Nancy Ip; Phone Number: 852-23587304; Email: boip@ust.hk
• Study Contact Backup: Name: Danise Au; Phone Number: 852-23588973; Email: daniseau@ust.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong University of Science and Technology
    • Contact: Nancy Ip; Phone Number: 852-23587304; Email: boip@ust.hk
    • Contact: Danise Au; Phone Number: 852-23588973; Email: daniseau@ust.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Parkinson's disease patients of the movement disorder clinic at Queen Elizabeth Hospital Hong Kong

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Parkinson's disease patients who have received deep brain stimulation	Procedure: DBS; Deep brain stimulation surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood proteomic profile	Plasma proteins measured using high-throughput ultra-sensitive proteomics platform	From pre-operative to 5 years post-operative
Blood transcriptomic profile	Bulk RNA-sequencing of blood cells	From pre-operative to 5 years post-operative
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	From pre-operative to 5 years post-operative
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	From pre-operative to 5 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From pre-operative to 5 years post-operative
Non-Motor Symptoms Scale (NMSS)	Assessment of symptomatic burden of non-motor symptoms Higher score indicates a worse outcome Range: 0-360	From pre-operative to 5 years post-operative
Parkinson's Disease Sleep Scale - 2 (PDSS-2)	Rating scale assessing sleep disorders in PD Higher score indicates a worse outcome Range: 0-60	From pre-operative to 5 years post-operative
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	From pre-operative to 5 years post-operative
Depression, Anxiety, and Stress Scale - 21 (DASS-21)	Self-report scale measuring depression, anxiety, and stress Higher scores indicate a worse outcome Range: Depression: 0-42 Anxiety: 0-42 Stress: 0-42	From pre-operative to 5 years post-operative
Schwab and England Activities of Daily Living Scale (S&E ADL scale)	Assessment of ability to accomplish essential activities of daily living Higher score indicates a better outcome Range: 0-100%	From pre-operative to 5 years post-operative

Collaborators and Investigators

• Sponsor: Hong Kong University of Science and Technology
• Collaborators: Queen Elizabeth Hospital, Hong Kong; Hong Kong Center for Neurodegenerative Diseases
• Investigators: Principal Investigator: Nancy Ip, The Hong Kong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): February 1, 2036
• Study Completion (Estimated): February 1, 2038

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: deep brain stimulation; proteomic; Parkinson's disease; DBS; transcriptomic; multiomic
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: HREP-2024-0289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO