Parkinsons Disease (PD)NCT07700862
Directional PSA Versus STN DBS for TD-PD
A study testing directional Deep brain stimulation in people with Parkinsons Disease (PD), 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) using directional lead 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 80 years
- Conditions the study is for
- Parkinsons Disease (PD)
- What is being tested?
- directional Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to Jun 2029
- Phase
- Interventional
- 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 80 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 off-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the off-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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Dianyou Li, MD, PhD, +0086-021-64370045, ldy11483@rjh.com.cn
About this study
Official title: Directional 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) using directional lead for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Read the detailed description
This single-center trial utilizes directional deep brain stimulation (DBS) current-steering technology to compare the clinical efficacy and tolerability of the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (TD-PD) within the same subject. The study is optimized into a two-phase framework to maximize patient safety and protocol compliance:
Phase 1: Two-month post-implantation, acute mapping is conducted to define the therapeutic window for PSA and STN configurations in a blinded randomized order. If a configuration induces immediate, unmanageable adverse events before reaching efficacy, it is classified as "intolerant" and excluded from that participant's subsequent chronic phase.
Phase 2 (Chronic Crossover): Participants with tolerated configurations are entered into a chronic randomized phase with a blinded sequence of 2-month PSA or STN chronic stimulation. Following the core two-arm crossover, all eligible patients transition into an open-label, exploratory sequential add-on phase of 2-month with combined PSA+STN stimulation to evaluate potential synergistic benefits.
All participants will then be followed-up up to 12 months after surgery.
- Conditions
- Parkinsons Disease (PD)
- Being tested
- directional Deep brain stimulation
- Keywords
- tremor-dominant Parkinson's disease, directional 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.
directional Deep brain stimulationDevice
active directional DBS with optimal stimulating parameters
| Study group | Role | What they receive |
|---|---|---|
| directional PSA-STN | Experimental | Participants randomized in this arm will receive the bilateral directional PSA stimulation and then will be crossovered to the bilateral directional STN stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional PSA stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional STN stimulation for another two months. Receives: Device: directional Deep brain stimulation |
| directional STN-PSA | Experimental | Participants randomized in this arm will receive the bilateral directional STN stimulation and then will be crossovered to the bilateral directional PSA stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional STN stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional PSA stimulation for another two months. Receives: Device: directional Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III tremor subscore Between PSA and STN Stimulation in the chronic randomized phase
The tremor subscore is derived from the sum of items 3.15 to 3.18 of the MDS-UPDRS-III. This measure directly compares the within-subject efficacy of directional PSA stimulation versus directional STN stimulation in the chronic cross-over phase. Lower scores indicate greater tremor suppression.
Measured: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Secondary outcomes (6)
Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale Between PSA and STN Stimulation in the chronic randomized phase
Measured: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III total score Between PSA and STN Stimulation in the chronic randomized phase
Measured: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Berg Balance Scale score Between PSA and STN Stimulation in the chronic randomized phase
Measured: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in 39-item Parkinsons disease questionnaire Between PSA and STN Stimulation in the chronic randomized phase
Measured: Baseline (pre-operation) and the end of each 2-month stimulation period (Month 4 and Month 6)
Proportion of Participants with Acute Phase Intolerance to Single-Target Stimulation
Measured: Up to 2 months after sugery
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 posted14 Jul 2026
- Study start1 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI DIANYOU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700862
- Sponsor's protocol ID
- dPSA-STNforTD-PD
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directional 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
- NCT07700862
- Acronym / sponsor ID
- dPSA-STNforTD-PD
- Conditions
- Parkinsons Disease (PD)
- Keywords
- tremor-dominant Parkinson's disease, directional deep brain stimulation, posterior subthalamic area, subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 14 Jul 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 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) using directional lead for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Detailed description
This single-center trial utilizes directional deep brain stimulation (DBS) current-steering technology to compare the clinical efficacy and tolerability of the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (TD-PD) within the same subject. The study is optimized into a two-phase framework to maximize patient safety and protocol compliance:
Phase 1: Two-month post-implantation, acute mapping is conducted to define the therapeutic window for PSA and STN configurations in a blinded randomized order. If a configuration induces immediate, unmanageable adverse events before reaching efficacy, it is classified as "intolerant" and excluded from that participant's subsequent chronic phase.
Phase 2 (Chronic Crossover): Participants with tolerated configurations are entered into a chronic randomized phase with a blinded sequence of 2-month PSA or STN chronic stimulation. Following the core two-arm crossover, all eligible patients transition into an open-label, exploratory sequential add-on phase of 2-month with combined PSA+STN stimulation to evaluate potential synergistic benefits.
All participants will then be followed-up up to 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| directional PSA-STN | Experimental | Device: directional Deep brain stimulationParticipants randomized in this arm will receive the bilateral directional PSA stimulation and then will be crossovered to the bilateral directional STN stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional PSA stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional STN stimulation for another two months. |
| directional STN-PSA | Experimental | Device: directional Deep brain stimulationParticipants randomized in this arm will receive the bilateral directional STN stimulation and then will be crossovered to the bilateral directional PSA stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional STN stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional PSA stimulation for another two months. |
Who may qualify
- Ages
- 18 to 80 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 off-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the off-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 |
|---|---|---|
| directional Deep brain stimulationactive directional DBS with optimal stimulating parameters | Device | directional PSA-STN, directional STN-PSA |
Primary outcome
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III tremor subscore Between PSA and STN Stimulation in the chronic randomized phase
Time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
The tremor subscore is derived from the sum of items 3.15 to 3.18 of the MDS-UPDRS-III. This measure directly compares the within-subject efficacy of directional PSA stimulation versus directional STN stimulation in the chronic cross-over phase. Lower scores indicate greater tremor suppression.
6 secondary outcomes
Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale Between PSA and STN Stimulation in the chronic randomized phase
Time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III total score Between PSA and STN Stimulation in the chronic randomized phase
Time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Berg Balance Scale score Between PSA and STN Stimulation in the chronic randomized phase
Time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in 39-item Parkinsons disease questionnaire Between PSA and STN Stimulation in the chronic randomized phase
Time frame: Baseline (pre-operation) and the end of each 2-month stimulation period (Month 4 and Month 6)
Proportion of Participants with Acute Phase Intolerance to Single-Target Stimulation
Time frame: Up to 2 months after sugery
Adverse events
Time frame: Up to 12 months after surgery
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 14 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing directional Deep brain stimulation in people with Parkinsons Disease (PD), 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: looking for participants now, as of the sponsor's last update on 14 Jul 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 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?
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 Dianyou Li, MD, PhD (+0086-021-64370045, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III tremor subscore Between PSA and STN Stimulation in the chronic randomized phase (time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)). 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 14 Jul 2026.