Nerve implants could give amputees better control of robotic legs
NCT ID NCT06275282
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether small implants placed on nerves in the thigh can help people with above-knee amputations control a robotic leg more naturally and feel sensations from it. Three participants will undergo surgery to create regenerative nerve interfaces and have electrodes implanted. Over a year, researchers will measure signal strength, movement accuracy, and sensory feedback. The goal is to improve function and quality of life, but the trial is very small and the electrodes are removed after the study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- regenerative peripheral nerve interfaces (RPNIs) with implanted electrodes
- What this could lead to
- If it works, this could lead to better control and natural feeling of advanced prosthetic legs for people with above-knee amputations.
- What could go wrong
- This is a very early, tiny trial with only 3 participants. The surgery is invasive, and the electrodes are removed after one year. It may not work for everyone or lead to a long-term solution.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Unilateral amputation of the leg proximal to the knee at least 6 months prior to enrollment. * Low surgical risk (American Society of Anesthesiologists Class I and II). * For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedures. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study. * Amputee Mobility Predictor with prosthesis (AMPPRO) score of at least 37 (Gailey et al. 2002). * Sufficient clearance to a motorized prosthetic leg without the necessity for shoe lifts or extenders on the contralateral limb. Exclusion Criteria: * Severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation. * Untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional. * Any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease. * Participants must not have used tobacco for at least one month prior to enrollment in the study. * Participants must agree to not use tobacco for the duration of the study. * Pregnancy. * No other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices. * Severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity. * An autoimmune condition which is not well controlled by medication. * A significant injury of the contralateral limb. * Significant, uncorrected vision problems. * Impaired mental capacity that negatively impacts verbal communication with the clinicians and research team or requires a Legally Authorized Representative to facilitate communication.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a motorized knee help amputees walk more? trial puts it to the test
- Can a breathable liner stop the sweat inside a prosthetic leg?
- Can we predict prosthetic success? a study seeks answers
- Can bionic limbs feel real? a trial tests touch feedback for amputees
- Can a common anesthetic dampen phantom limb pain?
- Can tiny electrodes give amputees a better grip on bionic limbs?