Micro-Electrodes Implanted in a Human Nerve

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Amputations; Spinal Cord Injury; Peripheral Nerve Injury

Treatments: Device: Utah Slanted Electrode Array

Study type: Interventional

Funder types: Other

Identifiers

NCT02034461

55621

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Acute surgical implantation

Experimental group

Description:

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.

Treatment:

Device: Utah Slanted Electrode Array

Implantation of a Utah Electrode Array

Experimental group

Description:

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.

Treatment:

Device: Utah Slanted Electrode Array