Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Sensory Feedback Useful for Controlling a Prosthetic Device?

What this Trial Is About

Researchers are evaluating the use of microelectrode slanted arrays implanted into peripheral nerves and muscles of patients with upper-limb amputations. The study aims to determine if these electrodes can record neural signals to control advanced prosthetic limbs and provide sensory feedback, including touch and muscle position sense. This early feasibility study explores the HAPTIX System's ability to assist amputees in daily activities using neurostimulation and electromyography (EMG). The intervention involves surgically implanting up to three percutaneous Utah Slanted Electrode Arrays (pUSEAs) into residual arm nerves and up to eight EMG electrodes into residual forearm muscles. These devices record motor signals that are decoded to control a dexterous prosthetic arm, such as the DEKA LUKE arm. Nerve stimulation is provided through individual electrodes to evoke sensory perceptions. The study includes implantation procedures and monitoring of the device's interaction with nerve endings. Participants will have their neural and muscle signals recorded and monitored over up to two years, with measurements including action potentials in millivolts. The researchers will assess the safety and functional capabilities of the implanted arrays and the prosthetic control system. The study involves follow-up visits to evaluate the prosthesis control and sensory feedback, with ongoing safety assessments. Total participation may extend up to two years depending on follow-up.

Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?