Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dopamine-resistant Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 dopamine-resistant tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• diagnosis of idiopathic Parkinson's disease

• tremor-dominant subtype in the on-medication condition

• dopamine-resistant tremor (i.e., preoperative levodopa responsiveness < 24% regarding the tremor subscore of the MDS UPDRS-III or uncontrolled tremor regardless of LEDD over 900 mg or maximal tolerated dose)

Locations
Other Locations
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Recruiting
Shanghai
Contact Information
Primary
Dianyou Li, MD, PhD
ldy11483@rjh.com.cn
+0086-021-64370045
Time Frame
Start Date: May 1, 2022
Estimated Completion Date: May 2027
Participants
Target number of participants: 30
Treatments
Experimental: PSA-STN
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.
Experimental: STN-PSA
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.
Authors
Sponsors
Collaborators: Suzhou Sceneray Medical Co. , Ltd
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials