PSA Versus STN DBS for TD-PD — PSA-STN  

Parkinson Disease Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05382858
• Study type: Interventional
• Source: Ruijin Hospital
• Contact: Dianyou Li, MD, PhD
• Phone: +0086-021-64370045
• Email: ldy11483@rjh.com.cn
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Completion date: May 2027