Micro-Electrodes Implanted in a Human Nerve
Amputations, Peripheral Nerve Injury, Spinal Cord Injury
About this trial
This is an interventional device feasibility trial for Amputations focused on measuring Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age and less than 65 years of age
- amputations
- peripheral nerve injury
- twelve participants for the 30 day implantation/physiological experimentation study
- three participants for the acute surgical implantation part of the study
Exclusion Criteria:
- incarceration
- pregnancy
- inability to consent
- psychiatric comorbidity
- increase the risk of adverse effects of general anesthesia
Sites / Locations
- The University Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Acute surgical implantation
Implantation of a Utah Electrode Array
The investigators will conduct three acute surgeries where a Utah slanted Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb amputations. These acute implantations will provide the PI with human surgical experience in implanting USEAs and evaluating the containment system the investigators will be using to immobilize the implanted USEA in the nerve.
The arm which has been amputated or has peripheral nerve trauma. Intervention include insertion of the Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation.