Using a Regenerative Peripheral Nerve Interface to Improve Control of Lower Limb Prostheses
Regenerative Peripheral Nerve Interfaces to Enhance Function and Sensation in People With Transfemoral Amputation
This study is testing whether a new nerve interface can help people with above-knee amputations have better control and feeling in their robotic legs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06275282 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral above-knee amputations who have sufficient soft tissue quality and meet specific mobility criteria.
Not a fit: Patients with severe pain syndromes or significant scarring from injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the control and functionality of prosthetic limbs for individuals with above-knee amputations.
How similar studies have performed: While the concept of biologic interfaces is emerging, this specific application of RPNI for prosthetic control is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.