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Micro-Electrodes Implanted in a Human Nerve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034461
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah

Brief Summary:

The investigators will study basic physiology of human peripheral nerves 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 : April 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acute surgical implantation Device: Utah Slanted Electrode Array
This study is using the microelectrode array device for scientific purposes only. This device will not be promoted or test marketed, and is not available for commercial distribution. There will be no costs to the participants for this device. This study is not aimed at collecting data for pre-market approval.

Experimental: Implantation of a Utah Electrode Array
Arm which has been amputated or has peripheral nerve trauma. Interventions include insertion of the Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about nerve stimulation.
Device: Utah Slanted Electrode Array
This study is using the microelectrode array device for scientific purposes only. This device will not be promoted or test marketed, and is not available for commercial distribution. There will be no costs to the participants for this device. This study is not aimed at collecting data for pre-market approval.




Primary Outcome Measures :
  1. Physiological data will be recorded from peripheral nerves, and will consist of action potentials (mV) arising from the axons surrounding the tip of each electrode. [ Time Frame: Up to 4 Week Follow-up ]

Secondary Outcome Measures :
  1. Assess the histological response of the peripheral nerve to the array in terms of scar formation, inflammation, etc. at four weeks post implantation. [ Time Frame: Up to 4 week follow-up ]
    Qualitative histological evaluation of the specimens will include, but not be limited to: analysis of immune cells/molecules; analysis of nerve tissue proximal and distal to the implant site (for number of fibers, size of fibers, etc); evaluation of depth of electrodes; evaluation of immune cells/markers around the electrode array; fibrous scar tissue formation; etc.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034461


Locations
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United States, Utah
The University Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Douglas Hutchinson Orthopedic Surgery
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Responsible Party: Douglas Hutchinson, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT02034461    
Other Study ID Numbers: 55621
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Keywords provided by Douglas Hutchinson, University of Utah:
Micro-Electrodes
Peripheral Nerve Injury
Amputation
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Peripheral Nerve Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases