Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: 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 dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Diagnosed with dystonic tremor based on the MDS 2018 consensus
• Duration of DT symptoms: ≥3 years of motor symptoms
• If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
• Good compliance and written informed consent
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: 2024-12
Estimated Completion Date: 2029-03
Participants
Target number of participants: 20
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.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital
Collaborators: Suzhou Sceneray Medical Co. , Ltd, Beijing Pins Medical Co., Ltd