PSA Versus STN DBS for TD-PD

NCT05382858 | Completed DMC

• 1 other identifier: TDPSA
• Study Type: interventional
• Target: 27
• 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) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (31)

• Change from baseline MDS UPDRS-III 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 MDS UPDRS-III 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 Fahn-Tolosa-Marin Clinical Rating Scale 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 Fahn-Tolosa-Marin Clinical Rating Scale 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 Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase

  up to 6 months (4-6 months depending on randomization arm)

Study Arms (2)

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.

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.

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

active DBS with optimal stimulating parameters

PSA-STN; STN-PSA

Eligibility Criteria

• Age: 18 Years - 75 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 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

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
• Suzhou Sceneray Medical Co. , Ltd: collaborator

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Dianyou Li, MD, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

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: Doctor

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2022
• Primary Completion: April 24, 2025
• Study Completion: August 26, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-10

Locations

CN (1)