Deep Brain StimulationNCT07376278
Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease
An observational study of Deep Brain Stimulation and PARKINSON DISEASE (Disorder), run by Hong Kong University of Science and Technology at 1 site in Hong Kong.
Trial 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. What factors in blood (proteins and RNA) are associated with good vs poor response to DBS? 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deep Brain Stimulation, PARKINSON DISEASE (Disorder)
- What is being tested?
- DBS
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Feb 2026to 1 Feb 2038
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease patients of the movement disorder clinic at Queen Elizabeth Hospital Hong Kong
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong University of Science and Technology
Hong Kong
Nancy Ip, 852-23587304, boip@ust.hk
Danise Au, 852-23588973, daniseau@ust.hk
About this study
Official title: 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:
- What factors in blood (proteins and RNA) are associated with good vs poor response to DBS?
- Are these factors able to predict response to DBS?
- 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.
Read the 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.
- Being tested
- DBS
- Keywords
- deep brain stimulation, DBS, Parkinson's disease, multiomic, transcriptomic, proteomic
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSProcedure or surgery
Deep brain stimulation surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Parkinson's disease patients who have received deep brain stimulation Receives: Procedure: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood proteomic profile
Plasma proteins measured using high-throughput ultra-sensitive proteomics platform
Measured: From pre-operative to 5 years post-operative
Blood transcriptomic profile
Bulk RNA-sequencing of blood cells
Measured: 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
Measured: 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
Measured: From pre-operative to 5 years post-operative
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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%
Measured: From pre-operative to 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start5 Feb 2026
- Primary completion1 Feb 2036 (estimated)
- Study completion1 Feb 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hong Kong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Hong Kong Center for Neurodegenerative Diseases
- Responsible party
- Principal investigator, Danise Au, Hong Kong University of Science and Technology
- Investigators
- Nancy Ip, Principal investigator, The Hong Kong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376278
- Sponsor's protocol ID
- HREP-2024-0289
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study for the Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07376278
- Acronym / sponsor ID
- HREP-2024-0289
- Keywords
- deep brain stimulation, DBS, Parkinson's disease, multiomic, transcriptomic, proteomic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hong Kong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Hong Kong Center for Neurodegenerative Diseases
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 1 Feb 2036 (estimated)
- Study completion
- 1 Feb 2038 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What factors in blood (proteins and RNA) are associated with good vs poor response to DBS?
- Are these factors able to predict response to DBS?
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Procedure: DBSParkinson's disease patients who have received deep brain stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients of the movement disorder clinic at Queen Elizabeth Hospital Hong Kong
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBSDeep brain stimulation surgery | Procedure or surgery | Treatment |
Primary outcome
Blood proteomic profile
Time frame: From pre-operative to 5 years post-operative
Plasma proteins measured using high-throughput ultra-sensitive proteomics platform
Blood transcriptomic profile
Time frame: From pre-operative to 5 years post-operative
Bulk RNA-sequencing of blood cells
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: From pre-operative to 5 years post-operative
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
Hoehn and Yahr (H&Y) stage
Time frame: From pre-operative to 5 years post-operative
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
6 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: From pre-operative to 5 years post-operative
Non-Motor Symptoms Scale (NMSS)
Time frame: From pre-operative to 5 years post-operative
Parkinson's Disease Sleep Scale - 2 (PDSS-2)
Time frame: From pre-operative to 5 years post-operative
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time frame: From pre-operative to 5 years post-operative
Depression, Anxiety, and Stress Scale - 21 (DASS-21)
Time frame: From pre-operative to 5 years post-operative
Schwab and England Activities of Daily Living Scale (S&E ADL scale)
Time frame: From pre-operative to 5 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Ip principal investigator
The Hong Kong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation and PARKINSON DISEASE (Disorder), run by Hong Kong University of Science and Technology at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Ip (852-23587304, boip@ust.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood proteomic profile (time frame: From pre-operative to 5 years post-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.