Micro-Electrodes Implanted in a Human Nerve

NCT02034461 | Terminated DMC

• 1 other identifier: 55621
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputations; Peripheral Nerve Injury; Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Acute surgical implantation

EXPERIMENTAL

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

Implantation of a Utah Electrode Array

EXPERIMENTAL

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

Interventions

Utah Slanted Electrode Array DEVICE

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.

Acute surgical implantation; Implantation of a Utah Electrode Array

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

The University Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases

Study Officials

• Douglas Hutchinson

  Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: January 13, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

US (1)