Feasibility Study of the ReHAB System to Restore Arm and Hand Movement in People with Tetraplegia

What this Trial Is About

Researchers are evaluating a novel system designed to help people with severe arm paralysis, known as tetraplegia, caused by diseases or injuries like spinal cord injury or stroke. This system combines small electrodes implanted in the brain areas controlling movement and sensation with electrodes on the upper arm and shoulder to stimulate paralyzed muscles. The goal is to measure intended movements through brain signals and stimulate muscles accordingly to restore arm and hand function. This is an open-label, exploratory safety and feasibility study enrolling up to 12 participants. The study involves surgical implantation of the Reconnecting the Hand and Arm to the Brain ReHAB System, which includes brain-computer interface BCI and functional electrical stimulation FES components. After implantation, participants will undergo research sessions over 13 months to test and adjust the device. Following this period, participants can choose to remove the device or continue in a long-term extension study lasting up to 5 years. Participants will be closely monitored through frequent visits and evaluations during the 13-month testing phase. Researchers will assess safety by tracking treatment-related adverse events and measure functional improvements using tasks such as brain-controlled cursor movement, activities of daily living tests, and grasp-release tasks. Participants must be available for ongoing follow-up and may allow video recordings of procedures and evaluations. The trial aims to determine the safety, tolerability, and potential effectiveness of this combined brain and muscle stimulation approach for restoring arm and hand movement.

An Early Feasibility Study of the ReHAB System