Evaluating Restored Lower Limb Sensation Using Implanted Electrodes in Adults with Diabetic Peripheral Neuropathy and Amputation

What this Trial Is About

This research aims to evaluate the effects of restoring sensation in individuals with above and below the knee limb loss caused by diabetic peripheral neuropathy. The study focuses on how implanted electrodes can send small electrical currents to remaining nerves, enabling signals to reach the brain similarly to natural limb sensation. It also explores the use of implanted muscle recording electrodes to help develop a motor controller for intuitive control of a robotic prosthetic leg. Participants will have electrodes surgically implanted on one to four nerves in the residual limb. Intramuscular recording electrodes may also be placed in the lower limb and hip muscles to capture electromyography EMG signals. These signals will be used to create an algorithm to operate an advanced robotic prosthesis, allowing control of prosthetic joint movements. An external wearable device will deliver electrical pulses to the implanted system. Participants will wear the instrumented prosthesis during various functional activities such as standing, walking, climbing stairs, and while experiencing visual or mental distractions. Throughout the study, participants will undergo testing involving small amounts of nerve stimulation through the implanted electrodes. Researchers will measure stimulation thresholds at nine months and assess functional gait at six months after implant. They will also evaluate neuropathic pain syndrome up to four years post-implant. The study involves regular follow-up to monitor how well the system works and to ensure participant safety during the extended observation period.

Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy