Recruiting

Regenerative Peripheral Nerve Interface

Sponsor:

University of Michigan

Code:

NCT06275282

Conditions

Amputation

Prostheses and Implants

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intramuscular electrodes

Study Details

Brief 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

Study ID

NCT06275282

Start date

Feb 13, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Regenerative Peripheral Nerve Interface (RPNI)

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

Interventions

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.

Primary outcome measure

  • Intensity of pain in residual and phantom limbs [ Time Frame: through study completion, an average of 1 year ]
  • Neuropathic Pain in residual limb [ Time Frame: through study completion, an average of 1 year ]
  • Health-Related Quality of Life [ Time Frame: through study completion, an average of 1 year ]
  • Amplitude and signal-to-noise ratio for each RPNI [ Time Frame: Postoperatively at each experimental visit at 3,6,9 & 12 months ]
  • Classification accuracy for movements of the phantom limb [ Time Frame: Postoperatively at each experimental visit at 3,6,9 & 12 months ]
  • Threshold for sensation after electrical stimulation of RPNI [ Time Frame: Postoperatively at each experimental visit at 3,6,9 & 12 months ]

Central Contacts and Locations

Central contacts

Deanna Gates, PhD

734-647-2698gatesd@umich.edu

Natalie Greener, MPH

734-647-8419greenern@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Deanna Gates, PhD

723-647-2698gatesd@umich.edu

Principal Investigator:

Deanna Gates, PhD

More Information

Sponsor

University of Michigan

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • RPNI
  • Regenerative Peripheral Nerve Interface
  • Implanted Electrodes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-19.