Using a Regenerative Peripheral Nerve Interface to Improve Control of Lower Limb Prostheses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of a Regenerative Peripheral Nerve Interface (RPNI) to enhance the control and sensory feedback of advanced robotic limbs for individuals with above-knee amputations. The RPNI involves implanting a peripheral nerve into a free muscle graft, allowing for the generation of high-fidelity motor control signals and meaningful sensory feedback. The study aims to evaluate the stability and specificity of electromyography signals from the RPNI over a year following surgery. By addressing the limitations of current prosthetic devices, this approach seeks to improve the quality of life for amputees.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Deanna Gates, PhD — University of Michigan
• Study coordinator: Deanna Gates, PhD
• Email: gatesd@umich.edu
• Phone: 734-647-2698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.