Improving prosthetic limb control with implanted electrodes after nerve surgery
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
This study is testing if implanted electrodes can help people who have lost an arm control their prosthetic limb better after having surgery to repair their nerves.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT03260400 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of implanted bipolar percutaneous intramuscular electrodes in patients who have undergone regenerative peripheral nerve interface (RPNI) surgery following upper limb amputation. It aims to assess the ability of these electrodes to record electromyographic signals and deliver electrical stimulation to enhance control of advanced prosthetic limbs. Participants will have electrodes implanted for up to 7 years, with regular assessments to monitor their performance and safety. The study involves a single center and will enroll 10 subjects to gather preliminary data on this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 22 or older who have undergone upper limb amputation and are in good health.
Not a fit: Patients with severe pain syndromes or those with significant scarring from injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the control and functionality of prosthetic limbs for upper limb amputees.
How similar studies have performed: While this approach is innovative, similar studies involving regenerative peripheral nerve interfaces have shown promise in enhancing prosthetic control.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be 22 years of age or older. * Participants must have previously undergone an upper limb amputation proximal to the wrist. * 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 procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study. * Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk). * Participants must have reliable transportation. * Participants must be able to attend at minimum 2 visits per month while electrodes remain implanted. * Participants must be at least 6 months post-amputation. Exclusion Criteria: * Participants may not be suffering from any 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. * Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional. * Participants must not have 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. * Participants cannot have sustained bilateral upper extremity amputation. * Participants cannot be pregnant. * Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices. * Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity. * Participants must not have an autoimmune condition which is not well controlled by medication. * Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Paul Cederna, M.D. — University of Michigan
- Study coordinator: Paul Cederna, M.D.
- Email: cederna@umich.edu
- Phone: 734-936-5885
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.