Parkinson DiseasePSA-STNNCT05382858
PSA Versus STN DBS for TD-PD
A study testing Deep brain stimulation in people with Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 26 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- diagnosis of idiopathic Parkinson's disease
- tremor-dominant subtype in the on-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition
- receiving regular anti-parkinsonian drugs for more than 6 weeks
- good compliance and written informed consent provided
Who cannot join
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
- Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Read the detailed description
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
- Conditions
- Parkinson Disease
- Being tested
- Deep brain stimulation
- Keywords
- tremor-dominant Parkinson's disease, deep brain stimulation, posterior subthalamic area, subthalamic nucleus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
active DBS with optimal stimulating parameters
| Study group | Role | What they receive |
|---|---|---|
| PSA-STN | Experimental | Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months. Receives: Device: Deep brain stimulation |
| STN-PSA | Experimental | Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase
in the off-medication condition
Measured: up to 6 months
Secondary outcomes (31)
Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline MDS UPDRS-III to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Timed up and go test (TUG) to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Berg balance scale to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Berg balance scale to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline 39-item Parkinsons disease questionnaire to the end of PSA stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline 39-item Parkinsons disease questionnaire to the end of STN stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Levodopa equivalent daily dose to the end of PSA stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Levodopa equivalent daily dose to the end of STN stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline maximal phonatory time to the end of PSA stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline maximal phonatory time to the end of STN stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline dysphonia severity index to the end of PSA stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline dysphonia severity index to the end of STN stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Mini-Mental Status Exam to the end of PSA stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Mini-Mental Status Exam to the end of STN stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Beck depression inventory to the end of PSA stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Beck depression inventory to the end of STN stimulation phase in the randomization phase
Measured: up to 6 months (4-6 months depending on randomization arm)
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the MDS UPDRS-III in the randomized phase
in the off-medication condition
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Fahn-Tolosa-Marin Clinical Rating Scale in the randomized phase
in the off-medication condition
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Timed up and go test (TUG) in the randomized phase
in the off-medication condition
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Berg balance scale in the randomized phase
in the off-medication condition
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the 39-item Parkinson's disease questionnaire in the randomized phase
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the levodopa equivalent daily dose in the randomized phase
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the beck depression inventory in the randomized phase
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the maximal phonatory time in the randomized phase
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the dysphonia severity index in the randomized phase
Measured: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Mini-Mental Status Exam in the randomized phase
Measured: up to 6 months
Adverse events
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022
- Primary completion24 Apr 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd
- Responsible party
- Principal investigator, LI DIANYOU, Ruijin Hospital
- Investigators
- Dianyou Li, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382858
- Sponsor's protocol ID
- TDPSA
- Acronym
- PSA-STN
- Status last verified
- Oct 2025
- First submitted
- 1 May 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin Z, Zeng Z, Pan Y, Huang P, Tan Y, Zhang C, Sun B, Li D. Deep Brain Stimulation of the Posterior Subthalamic Area and the Subthalamic Nucleus in Tremor-Dominant Parkinson's Disease: A Randomized, Crossover Trial. Mov Disord. 2026 May 24. doi: 10.1002/mds.70363. Online ahead of print.
PubMed 42178793
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial
- ClinicalTrials.gov ID
- NCT05382858
- Acronym / sponsor ID
- PSA-STN / TDPSA
- Conditions
- Parkinson Disease
- Keywords
- tremor-dominant Parkinson's disease, deep brain stimulation, posterior subthalamic area, subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 19 May 2022 (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 aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Detailed description
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSA-STN | Experimental | Device: Deep brain stimulationParticipants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months. |
| STN-PSA | Experimental | Device: Deep brain stimulationParticipants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of idiopathic Parkinson's disease
- tremor-dominant subtype in the on-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition
- receiving regular anti-parkinsonian drugs for more than 6 weeks
- good compliance and written informed consent provided
Key exclusion criteria (6 listed)
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
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 |
|---|---|---|
| Deep brain stimulationactive DBS with optimal stimulating parameters | Device | PSA-STN, STN-PSA |
Primary outcome
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase
Time frame: up to 6 months
in the off-medication condition
31 secondary outcomes
Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline MDS UPDRS-III to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Timed up and go test (TUG) to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Berg balance scale to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Berg balance scale to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline 39-item Parkinsons disease questionnaire to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline 39-item Parkinsons disease questionnaire to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Levodopa equivalent daily dose to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Levodopa equivalent daily dose to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline maximal phonatory time to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline maximal phonatory time to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline dysphonia severity index to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline dysphonia severity index to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Mini-Mental Status Exam to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Mini-Mental Status Exam to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Beck depression inventory to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Beck depression inventory to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the MDS UPDRS-III in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Fahn-Tolosa-Marin Clinical Rating Scale in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Timed up and go test (TUG) in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Berg balance scale in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the 39-item Parkinson's disease questionnaire in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the levodopa equivalent daily dose in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the beck depression inventory in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the maximal phonatory time in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the dysphonia severity index in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Mini-Mental Status Exam in the randomized phase
Time frame: up to 6 months
Adverse events
Time frame: up to 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 42178793Lin Z, Zeng Z, Pan Y, Huang P, Tan Y, Zhang C, Sun B, Li D. Deep Brain Stimulation of the Posterior Subthalamic Area and the Subthalamic Nucleus in Tremor-Dominant Parkinson's Disease: A Randomized, Crossover Trial. Mov Disord. 2026 May 24. doi: 10.1002/mds.70363. Online ahead of print.
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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. This study is not recruiting at the moment.
Dianyou Li, MD, PhD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Parkinson Disease, run by Ruijin Hospital at 1 site in China.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Dec 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382858, which also lists 1 linked publication.
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 2 Dec 2025.