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Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses

NCT06275282 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-05-19

No results posted yet for this study

Summary

Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration.

The main questions it aims to answer are:

1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery?
2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom?
3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback?

Consenting participants with unilateral transfemoral amputation (TFA) will:

1. Undergo RPNI surgery and electrode implantation in the residual limb.
2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation.
3. Undergo explantation of electrodes following the conclusion of data collection.

Conditions

  • Amputation
  • Prostheses and Implants

Interventions

DEVICE

Intramuscular electrodes

Participants will have regenerative peripheral nerve interfaces (RPNIs) created on nerves in their residual thighs. During either the same surgery or a separate surgery, small electrodes will be implanted into these RPNIs.

Sponsors & Collaborators

Principal Investigators

  • Deanna Gates, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275282 on ClinicalTrials.gov