Micro-Electrodes Implanted in a Human Nerve

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02034461

Enrollment

Registered

2014-01-13

Start date

2013-04-30

Completion date

2021-04-30

Last updated

2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputations, Peripheral Nerve Injury, Spinal Cord Injury

Keywords

Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury

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.

Interventions

DEVICEUtah 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026