Micro-Electrodes Implanted in a Human Nerve

Spinal Cord Injury Clinical Trial

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02034461
• Other study ID #: 55621
• Status: Terminated
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2021

Study information

• Verified date: July 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputations
• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	The University Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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