NCT04616521

Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study

Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	Deep brain stimulation	The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.

Timeline

• Start date: 2021-01-01
• Primary completion: 2029-11-30
• Completion: 2030-11-30
• First posted: 2020-11-05
• Last updated: 2020-12-24