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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
• 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)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Dianyou Li, MD, PhD
Start Date:May 1, 2022
Estimated Completion Date:May 2027
Target number of participants:30
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.
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.