Study of a Wireless Brain-Computer Interface to Restore Hand Function in Adults with Tetraplegia from Spinal Cord Injury Evaluating Safety and Clinical Benefit

What this Trial Is About

Researchers are evaluating an implantable brain-computer interface BCI system designed to restore upper-limb function in adults with tetraplegia caused by spinal cord injury. This prospective, multicenter, single-arm clinical trial aims to assess the safety and clinical effectiveness of this device as a functional replacement for hand motor control. Participants will receive implantation of the Triple-F BCI device, followed by standardized brain-computer training including the use of brain-controlled pneumatic gloves. After implantation, follow-up visits will be conducted at 1, 2, 3, and 6 months to monitor progress and device performance. During the study, participants will undergo assessments using various scales and tests to evaluate hand function and device reliability. These include the ARAT score with and without BCI assistance, task completion rates for brain-controlled hand movements, and measures of daily living activities and neurological status. Device operability and user experience will also be evaluated throughout the follow-up period, which lasts up to 6 months post-implantation.

A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety