Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals

Launched by UNIVERSITY OF MICHIGAN · Aug 21, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring a new device designed to help individuals who have had an upper limb amputation improve their control over prosthetic arms and hands. Specifically, the study is looking at a type of electrode that is implanted in the muscle after a regenerative nerve surgery. This could provide better signals for operating advanced prosthetic limbs, making them more functional and easier to use.

To participate in this study, you need to be at least 22 years old and have had an amputation above the wrist more than six months ago. You should be in good health and able to attend regular check-ups during the trial. It's important that you don’t have severe pain or certain medical conditions that could complicate surgery. If you’re interested in how this technology could improve prosthetic limb use, this trial might be a good opportunity for you. Participants will be closely monitored to ensure their safety and to assess how well the device works.

Gender

ALL

Eligibility 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