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Restoring sensation in lower limbs using implanted nerve electrodes

Plain-English translation of NCT04658693 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated August 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This research study is testing a new approach to help people who have had a lower limb amputation or severe nerve damage from diabetes. Researchers will surgically implant small electrodes on nerves in your remaining limb, and use an external wearable device to send electrical signals that can restore the sensation of touch and pressure. The goal is to help you move a robotic prosthesis more naturally and safely by giving your brain feedback about how the prosthesis is interacting with the ground.

People with lower limb amputation or severe diabetic nerve damage often struggle with balance, falls, and difficulty walking because they've lost the natural feeling in their limbs. This treatment aims to restore that lost sensation artificially, which could help you walk more safely and confidently while reducing injury risk.

Do you qualify?

You likely qualify if…

you have a lower limb amputation due to diabetes, or you have severe nerve damage in your foot from diabetes
you are able to walk or stand with a prosthesis or other assistive device
you have healthy nerves in your lower leg or hip that doctors have confirmed can receive the implanted electrodes
you have good skin health and practice good hygiene
you are medically stable without uncontrolled seizures, heart problems, or autoimmune diseases that would make electrical stimulation unsafe

You likely don't qualify if…

you have active pressure sores or open wounds on your skin
your diabetes is not well controlled (HbA1c of 8.5% or higher)
you have significant blood vessel disease or a history of poor wound healing
you have uncontrolled depression, psychosis, or serious cognitive impairment that would make it difficult to follow the study schedule
you may need an MRI scan during the study, since MRI is not safe with these implants in place

What participation looks like

You will undergo surgery to have thin electrode wires implanted on the nerves in your residual limb or lower leg, and possibly in some of your muscles to record movement signals. After implantation, you'll wear an external stimulation device that sends electrical pulses through the electrodes to create sensations in your lower limb. During study visits, you'll test a robotic prosthesis while performing everyday tasks like standing, walking, and climbing stairs—sometimes with distractions—so researchers can see how restoring sensation helps you move and balance better.

AI-generated summary from trial data · Aug 2, 2026 · Not medical advice

Restoring sensation in lower limbs using implanted nerve electrodes

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)