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Clinical Trials/NCT02034461
NCT02034461
Terminated
Not Applicable

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

University of Utah1 site in 1 country11 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputations
Sponsor
University of Utah
Enrollment
11
Locations
1
Primary Endpoint
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.
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
April 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Douglas Hutchinson

M.D.

University of Utah

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

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Study Sites (1)

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