Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia Patients

This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.

NCT Number	NCT07457645
Lead Sponsor	Shanghai Zhongshan Hospital
Conditions	Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury
Enrollment	10 participants
Start Date	2026-05-15
Primary Completion	2028-07-15 (estimated)
Study Completion	2028-10-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-28