Hello, At the University of Chicago we are conducting a study to investigate the use of brain-computer interface (BCI) technology. BCIs seek to enable the use of a robotic prosthetic arm, and other devices, by people with high-level paralysis to complete activities of daily living (bensmaialab.org/bci). This technology uses neural signals that are still generated in the brain even though they are not sent to the arms, hands, and legs after a spinal cord injury. If you choose to participate in the study, two small electrode arrays will be implanted in the area of the brain that controls your movements. Two more arrays will be implanted in the area of the brain that feels touch. The goal of this study is to determine if these arrays can be used for safe and effective long-term recording and stimulation of brain activity.
To participate in this research you must: 1. Have limited or no ability to use both hands due to cervical spinal cord injury, brainstem stroke, or spinal stroke. 2. Be 22-70 years old. 3. Live within 2 hours of the University of Chicago. We have approval from the FDA to conduct this study under an investigational device exemption. This can be found on the NIH's clinicaltrials.gov website, as NCT01894802. If you choose to participate in the study, you will undergo two surgical procedures, one to place the four electrode arrays, and one to remove them. The arrays, each approximately the size of a pencil eraser, will be implanted through a temporary 5x8 cm opening in your skull. The wires from the arrays will be attached to two connectors that are fixed to the skull where it can be connected to our computer system. While the arrays are implanted, our research team will conduct BCI training sessions multiple days per week. The goal of training is for you to learn to use your brain activity to control a robotic arm, and use a simulated sensation of touch generated by microstimulation pulses in the brain corresponding to touches made by the robotic hand. We may conduct BCI testing at our University of Chicago research lab or in your home. The study will run for 18-66 months, and the arrays will be removed at the end of the study. Success cannot be guaranteed, and research involving implantation of devices in the brain carries risks which will be further explained if you are interested in learning more about the study. If you are interested in participating in this study, or have further questions, please contact John Downey at bcist...@uchicago.edu or 773-834-5204. John Downey, Ph.D. Staff Scientist University of Chicago
