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Regenerative Peripheral Nerve Interface for Lower Limb Prostheses

This study is looking at a new way to help people with above-knee amputations control their prosthetic legs better and reduce pain. It uses something called Regenerative Peripheral Nerve Interfaces (RPNIs). These are created by implanting a nerve into a small piece of muscle in your residual (remaining) thigh. Then, small electrodes (tiny wires) are placed into these RPNIs. Researchers want to see if this helps you control a robotic prosthetic leg more naturally and if it can reduce pain in your residual limb and phantom limb (pain felt in the missing limb). They will also look at how this affects your quality of life. You might be able to join if you are between 18 and 75 years old, had an above-knee amputation at least 6 months ago, and are in good health for surgery. The study aims to enroll 3 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 3 participants.
What's involved
Participants will have RPNIs created on nerves in their residual thighs, and small electrodes will be implanted into these RPNIs during one or two surgeries.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels and quality of life will be measured throughout the study, for an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06275282

Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses

Recruiting
NAAges 18–75InterventionalBasic science
University of Michigan
~3 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Intramuscular electrodes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intensity of pain in residual and phantom limbs
Measured over through study completion, an average of 1 year
+5 more outcomes measured

Conditions

Amputation
Prostheses and Implants

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Amputation

NCT06275282

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Deanna Gates, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Deanna Gates, PhD
[email protected]
734-647-2698
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Intensity of pain in residual and phantom limbsthrough study completion, an average of 1 year

    Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a

  • Neuropathic Pain in residual limbthrough study completion, an average of 1 year

    Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

  • Health-Related Quality of Lifethrough study completion, an average of 1 year

    Participants will complete the RAND 36-Item Short Form Health Survey (SF-36)

  • Amplitude and signal-to-noise ratio for each RPNIPostoperatively at each experimental visit at 3,6,9 & 12 months

    Participants will be instructed to make large, sustained movements with their phantom lower extremity while in a seated position to estimate their maximum voluntary contraction. They will repeat this process five times for each movement. The signal-to-noise ratio (SNR) will be calculated as the ratio of that signal to the quiescent period signals.

  • Classification accuracy for movements of the phantom limbPostoperatively at each experimental visit at 3,6,9 & 12 months

    Participants will move their phantom limb to match a virtual limb shown on a screen. We will measure how accurately we can predict the intended movement using muscle activity signals from RPNIs and residual muscles

  • Threshold for sensation after electrical stimulation of RPNIPostoperatively at each experimental visit at 3,6,9 & 12 months

    We will stimulate RPNIs electrically through the implanted electrodes. We will quantify the charge necessary for the participant to feel sensation (perception threshold) and the minimum charge that becomes uncomfortable (discomfort threshold). We will also record the location and quality of the sensation felt at each threshold