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Clinical Trial NCT05505513 for Amputation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? 3

Recruiting
Clinical Trial NCT05505513 is an interventional study for Amputation that is recruiting. It started on December 21, 2020 with plans to enroll 3 participants. Led by University of Utah, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on October 6, 2025.
Brief Summary
The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to contr...Show More
Detailed Description
The investigators will assess the functional capability of microelectrode slanted arrays with a large number of electrodes implanted into peripheral nerves of patients with upper-limb transradial amputations. The investigators hypothesize that recording neural signals from individual electrodes will provide selective motor information that is adequate to allow control over artificial limbs with many moving parts, i.e...Show More
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?

Conditions
Amputation
Other Study IDs
  • 124231
NCT ID Number
NCT05505513
Start Date (Actual)
2020-12-21
Last Update Posted
2025-10-06
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
3
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Micro-Electrodes
Amputation
Prosthetic Device
Primary Purpose
Device Feasibility
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalImplantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)
The arm (s) of the patient which has been amputated. Intervention include insertion of the percutaneous Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation.
percutaneous Utah Slanted Electrode Arrays (pUSEAs)
Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Measure Action Potentials (millivolts, mV)
Three participants after receiving a stimuli will have action potentials (millivolts, mV) arising from the axons surrounding the tip of each electrode recorded in time. The moving action potentials (mV) measure five phases: resting potential, depolarization, peak, repolarization, and hyperpolarization.
Up to 2-years Follow-up
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • at least 18 years of age and less than 65 years of age
  • unilateral and bilateral traumatic or elective upper extremity amputations at the transradial level

  • incarceration
  • pregnancy
  • inability to consent
  • psychiatric comorbidity
  • medical conditions that significantly increase the risk of adverse effects of general anesthesia
University of Utah logoUniversity of Utah304 active studies to explore
Study Responsible Party
Douglas Hutchinson, Principal Investigator, Principle Investigator, University of Utah
Study Central Contact
Contact: Douglas Hutchinson, M.D., 801-587-5400, [email protected]
1 Study Locations in 1 Countries

Utah

The University Orthopaedic Center, Salt Lake City, Utah, 84108, United States
Douglas Hutchinson, M.D., Contact, 801-587-5453
Recruiting