NCT02937727

MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Beijing Pins Medical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.

Conditions

• Idiopathic Parkinson Patients

Interventions

Type	Name	Description
DEVICE	3T MRI compatible and LFP recordable G106R of Beijing Pins medical.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-10-01
• Completion: 2018-03-01
• First posted: 2016-10-19
• Last updated: 2017-06-23

Locations

3 sites across 1 country: China