Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Intramuscular electrodes
DeviceParticipants 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.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Regenerative Peripheral Nerve Interface (RPNI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intensity of pain in residual and phantom limbs
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a
Time frame
through study completion, an average of 1 year2
Neuropathic Pain in residual limb
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Time frame
through study completion, an average of 1 year3
Health-Related Quality of Life
Participants will complete the RAND 36-Item Short Form Health Survey (SF-36)
Time frame
through study completion, an average of 1 year4
Amplitude and signal-to-noise ratio for each RPNI
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.
Time frame
Postoperatively at each experimental visit at 3,6,9 & 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov