Micro-Electrodes Implanted in a Human Nerve

Study Overview
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Brief Summary
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The main objective of the intervention in the study is devise feasibility using high-count microelectrode arrays implanted into peripheral nerves of patients with limb amputations or peripheral nerve injury. These microelectrodes will be custom-made and are not available for commercial distribution. The investigators hypothesize that recording neural signals from a large number of microelectrodes will provide selective motor information in high enough numbers to allow control over future artificial devices with many moving parts, i.e. artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These studies will also investigate to what extent microstimulation of nerve fibers can provide sensory feedback from a prosthetic limb. The investigators will also conduct up to 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 Dr. Hutchinson with human surgical experience in implanting USEAs and evaluating the containment system we will be using to immobilize the implanted USEA in the nerve.

Official Title
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Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Sensory Feedback Useful for Controlling a Prosthetic Device?

Conditions
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Amputations, Peripheral Nerve Injury, Spinal Cord Injury

Intervention / Treatment
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* Device: Utah Slanted Electrode Array


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute surgical implantation<br>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. | Device: Utah Slanted Electrode Array<br>* Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations or peripheral nerve trauma.<br>|
| Experimental: Implantation of a Utah Electrode Array<br>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. | Device: Utah Slanted Electrode Array<br>* Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations or peripheral nerve trauma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device feasibility to collect data from peripheral nerves, and will consist of action potentials (mV) arising from the axons surrounding the tip of each electrode. | Device feasibility evaluation to confirm design and operating specifications of the device to collect action potentials from peripheral nerves. | Up to 4 Week Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury