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Micro-Electrodes Implanted in a Human Nerve

Primary Purpose

Amputations, Peripheral Nerve Injury, Spinal Cord Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Utah Slanted Electrode Array
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Amputations focused on measuring Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acute surgical implantation

Implantation of a Utah Electrode Array

Arm 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.

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.

Outcomes

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.
Device feasibility evaluation to confirm design and operating specifications of the device to collect action potentials from peripheral nerves.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2013
Last Updated
July 1, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT02034461
Brief Title
Micro-Electrodes Implanted in a Human Nerve
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 Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
This device feasibility study was using a microelectrode array device to determine viability of the product. Design and operating specification of the device were established. A new IDE trial has been initiated.
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputations, Peripheral Nerve Injury, Spinal Cord Injury
Keywords
Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute surgical implantation
Arm Type
Experimental
Arm 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.
Arm Title
Implantation of a Utah Electrode Array
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Utah Slanted Electrode Array
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Device feasibility evaluation to confirm design and operating specifications of the device to collect action potentials from peripheral nerves.
Time Frame
Up to 4 Week Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Hutchinson
Organizational Affiliation
Orthopedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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Micro-Electrodes Implanted in a Human Nerve

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