Pilot study of an implantable Brain-Computer Interface system with people with Locked-in Syndrome

Loss of motor control is a significant cause of dependency on professional care. Typical causes are spinal cord or brain trauma, motor neuron disease and stroke. Disabilities range from minor to severe, the latter being complete paralysis with intact mental capacities called Locked-In Syndrome. Conceptually it seems logical that damaged nerves can be bypassed with Brain-Computer Interfacing (BCI) technology that transforms mental intentions that are decoded from signals recorded from the brain, to actions. Scalp-EEG brain recordings do not perform well enough due to poor skull conductance. Electrodes implanted under the skull carry much more promise. Some prototype neuroprosthetic devices for communication exist but none operate at the users home without presence of researchers and their equipment, until now. After developing a system and providing proof of concept, we are ready to provide locked-in patients with an implantable BCI system that works at their home, without requiring any assistance. The implant is developed by Medtronic and Bakken Research Center (MBRC), our commercial partner in this study. The primary objective is to achieve communication via our BCI system in severely paralyzed patients, as measured in terms of writing text on a computer without help from someone else. Two secondary objectives are defined, being a) to improve Quality of Life and user satisfaction with the BCI system, and b) to assess experimental parameters for a larger clinical study. Our ultimate goal is to open the market for communication devices for disabled people, by providing clear evidence that BCI implants can enrich the lives of the severely disabled. Success of the project will result in our system being the very first commercial BCI implant.