NCT07376278

Brief Summary

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. 1.What factors in blood (proteins and RNA) are associated with good vs poor response to DBS?
  2. 2.Are these factors able to predict response to DBS?
  3. 3.How do these factors change before and after DBS?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
143mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Feb 2038

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2036

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2038

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

10 years

First QC Date

January 22, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

deep brain stimulationDBSParkinson's diseasemultiomictranscriptomicproteomic

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Montreal Cognitive Assessment (MoCA)

    From pre-operative to 5 years post-operative

  • Non-Motor Symptoms Scale (NMSS)

    From pre-operative to 5 years post-operative

  • Parkinson's Disease Sleep Scale - 2 (PDSS-2)

    From pre-operative to 5 years post-operative

  • Parkinson's Disease Questionnaire - 39 (PDQ-39)

    From pre-operative to 5 years post-operative

  • Depression, Anxiety, and Stress Scale - 21 (DASS-21)

    From pre-operative to 5 years post-operative

  • +1 more secondary outcomes

Study Arms (1)

Treatment

Parkinson's disease patients who have received deep brain stimulation

Procedure: DBS

Interventions

DBSPROCEDURE

Deep brain stimulation surgery

Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong University of Science and Technology

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, brain tissue

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nancy Ip

    The Hong Kong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant scientific officer

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

February 5, 2026

Primary Completion (Estimated)

February 1, 2036

Study Completion (Estimated)

February 1, 2038

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations