Research participant

The research participant was a 68-year-old male with a unilateral amputation of the right lower leg below the knee. The amputation occurred 18 years prior to study enrollment due to a non-healing wound from a motorcycle accident. In 2018, the participant received three surgically-implanted 16-channel Composite Flat Interface Nerve Electrodes (CFINEs) on his sciatic and tibial nerves (2 sciatic, 1 tibial). The electrodes were connected to percutaneous leads, which were routed through the skin in the upper leg. Electrical stimulation was sent to the nerves through the CFINEs and elicited somatosensory percepts arising from discrete locations on the missing limb that could be modulated by the applied stimulation parameters. The home study began 18 months after the participant received the implanted components of the system. Prior to entering the home study, the participant performed in-laboratory testing of his sensation and gait.

All study devices and procedures were reviewed and approved by the Cleveland Department of Veterans Affairs Medical Center Institutional Review Board, the Department of the Navy Human Research Protection Program, and the U.S. Food and Drug Administration under an Investigational Device Exemption. Study procedures and experiments were performed in accordance with the approved study protocols. Written informed consent was obtained from the participant prior to engaging in research activities.