Micro-Electrodes Implanted in a Human Nerve

Not Applicable

Terminated

• Conditions: Spinal Cord Injury; Peripheral Nerve Injury; Amputations
• Interventions: Device: Utah Slanted Electrode Array

• Registration Number: NCT02034461
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Read More

Exclusion Criteria

• incarceration
• pregnancy
• inability to consent
• psychiatric comorbidity
• increase the risk of adverse effects of general anesthesia

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation of a Utah Electrode Array	Utah Slanted 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.
Acute surgical implantation	Utah Slanted 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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University Orthopaedic Center; 🇺🇸 Salt Lake City, Utah, United States