PSA Versus STN DBS for TD-PD (PSA-STN)

November 24, 2025 updated by: LI DIANYOU, Ruijin Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PSA-STN
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.
Device: Deep brain stimulation
active DBS with optimal stimulating parameters
Experimental: STN-PSA
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.
Device: Deep brain stimulation
active DBS with optimal stimulating parameters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 12 months after surgery
up to 12 months after surgery
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)
in the off-medication condition
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)
in the off-medication condition
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)
in the off-medication condition
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)
in the off-medication condition
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)
in the off-medication condition
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)
in the off-medication condition
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)
in the off-medication condition
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)
in the off-medication condition
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
in the off-medication condition
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
in the off-medication condition
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
in the off-medication condition
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
in the off-medication condition
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
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
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
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
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
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Suzhou Sceneray Medical Co. , Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dianyou Li, MD, PhD, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TDPSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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