Improving prosthetic limb control with implanted electrodes after nerve surgery

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 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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must be 22 years of age or older.
* Participants must have previously undergone an upper limb amputation proximal to the wrist or are scheduled to undergo 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 6 hours of experiments per month while electrodes remain implanted.
* Participants must be at least 6 months post-amputation.
* Participants who will receive an amputation at the same time as RPNI grafts and electrodes must be undergoing an elective amputation surgery where loss of useful function of the hand has occurred. They must be at least 6 months post-injury or failed limb salvage to participate.

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing powered and mechanical prosthetic knees for K2-level amputees

  This study is testing whether powered prosthetic knees work better than mechanical ones for K2-level amputees to help improve their mobility and make better choices for future prosthetic designs.

  Recruiting Liberating Technologies, Inc. · Austin, Texas · NCT06194838

• Effect of EMG sensor number and placement on control of below-elbow prosthetic arms

  This project will test whether changing the number and placement of myoelectric sensors helps adults with below-elbow limb absence control a prosthetic arm better while wearing a real device.

  Recruiting Liberating Technologies, Inc. · Chicago, Illinois and 1 other locations · NCT07011420

• Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee amputation.

  This test will see if switching to a microprocessor-controlled prosthetic knee reduces fall-related health problems and improves walking speed, mobility, and quality of life for adults with above-knee amputations who are limited community ambulators compared with non-microprocessor knees.

  Recruiting Hanger Institute for Clinical Research and Education, LLC · Austin, Texas · NCT06937242

• Understanding the impact of powered prosthetics on walking for transfemoral amputees

  This study is testing whether powered knee and ankle prosthetics can help transfemoral amputees walk better, especially when combined with special training.

  Recruiting Shirley Ryan AbilityLab · Chicago, Illinois · NCT06433648

• Evaluation of a new myoelectric prosthesis for transradial amputees

  This study is testing a new type of prosthetic arm that uses a special implant to help people with below-the-elbow amputations control it more easily and naturally.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT05768802

• Hand prosthesis usability and performance evaluation for people with upper limb absence

  This study tests a new multi-articulating hand prosthesis to see if it performs better or differently than a participant’s own prosthesis.

  Recruiting Össur Iceland ehf · Dublin, Ohio · NCT07915700

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.