Study of an Implantable Neural Device to Help Patients with Quadriplegia Control Equipment Using Brain Signals

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an implantable neural acquisitor and stimulator system called NEO in patients with motor disabilities such as complete or incomplete quadriplegia caused by spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis, and other motor neuron disorders. This technology uses brain-computer interface methods to help patients control external devices like wheelchairs, robotic arms, and apps, aiming to improve their quality of life. Participants will receive the NEO device implanted to connect their brain signals to various external aids. The study focuses on monitoring the safety of the device over 12 months after implantation and assessing how well the brain-computer interface performs at 3, 6, and 12 months. Researchers will also track the monthly usage hours of the device and gather satisfaction feedback from patients and caregivers. During the study, participants will undergo neurological assessments and regular evaluations to monitor adverse events and device performance. Outcome measures include brain-computer interface accuracy, bit rate, usage duration, and satisfaction surveys at multiple timepoints up to one year. The trial is designed to carefully observe the effects and usability of the implanted system in adults aged 18 to 80 with stable motor disabilities.

Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability