[BrainConnexion] - Neurodevice Phase I Trial

About this trial

This trial is enrolling individuals with cervical (neck area) spinal cord injuries to test the usage of an implantable brain-computer electrode array (BrainConnexion) placed on the cortical surface of the brain. While SCI disrupts the nerve pathways involved in voluntary movement, brain activity to elicit movements is still generated. An implanted electrode array can record the neuronal activity of the motor cortex. This information can then be transferred to a computer program (brain-computer-interface) that directs a powered assistive device that can be guided by the user’s thoughts. This study will evaluate the safety of the device, as well as the efficacy of the electrodes for long-term recording of neural activities and thus control of the external assistive device. If included in the study, participants will have surgery to implant the electrode array. Brain activity will be wirelessly recorded and integrated with the prosthetic device at least once a week for 12 months.