Directional PSA Versus STN DBS for TD-PD

NCT07700862 | Recruiting FDA Device

• 1 other identifier: dPSA-STNforTD-PD
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinsons Disease (PD)

Keywords

tremor-dominant Parkinson's disease; directional deep brain stimulation; posterior subthalamic area; subthalamic nucleus

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Up to 2 months after sugery

Other Outcomes (6)

• Change from Baseline in Beck Depression Inventory-II Between PSA and STN Stimulation in the chronic randomized phase

  Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)

• Change from Baseline in Beck Anxiety Inventory Between PSA and STN Stimulation in the chronic randomized phase

  Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)

• Change from Baseline in nonmotor symptoms scale for Parkinson's disease (NMSS) Between PSA and STN Stimulation in the chronic randomized phase

  Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)

Study Arms (2)

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.

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.

Device: directional Deep brain stimulation

Interventions

directional Deep brain stimulation DEVICE

active directional DBS with optimal stimulating parameters

directional PSA-STN; directional STN-PSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Dianyou Li, MD, PhD

CONTACT

+0086-021-64370045; ldy11483@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

CN (1)