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

Shanghai Jiao Tong University

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05382858

TDPSA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 2 patient groups

PSA-STN

Experimental group

Description:

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.

Treatment:

Device: Deep brain stimulation

STN-PSA

Experimental group

Description:

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.

Treatment:

Device: Deep brain stimulation