Micro-Electrodes Implanted in a Human Nerve

Sponsor

University of Utah (Other)

Overall Status

Terminated

CT.gov ID

NCT02034461

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Amputations Peripheral Nerve Injury Spinal Cord Injury	Device: Utah Slanted Electrode Array	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acute surgical implantation 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 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.
Experimental: Implantation of a Utah Electrode Array 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 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.

Arm

Intervention/Treatment

Experimental: Acute surgical implantation

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

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.

Experimental: Implantation of a Utah Electrode Array

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

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.

Outcome Measures

Primary Outcome Measures

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. [Up to 4 Week Follow-up]
Device feasibility evaluation to confirm design and operating specifications of the device to collect action potentials from peripheral nerves.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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