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

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: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Deep brain stimulation

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: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	in the off-medication condition	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		up to 12 months after surgery
Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase	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	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	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	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	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	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	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	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		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		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		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		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		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		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		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		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		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		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		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		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	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	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	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	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		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		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		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		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		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		up to 6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Suzhou Sceneray Medical Co. , Ltd
• Investigators: Principal Investigator: Dianyou Li, MD, PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): August 26, 2025

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: deep brain stimulation; subthalamic nucleus; tremor-dominant Parkinson's disease; posterior subthalamic area
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Therapeutics; Surgical Procedures, Operative; Electric Stimulation Therapy; Deep Brain Stimulation
• Other Study ID 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