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Micro-Electrodes Implanted in a Human Nerve

NCT02034461 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-07-07

No results posted yet for this study

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

Interventions

DEVICE

Utah Slanted Electrode Array

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.

Sponsors & Collaborators

Principal Investigators

  • Douglas Hutchinson · Orthopedic Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034461 on ClinicalTrials.gov