Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
1 other identifier
interventional
3
1 country
1
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 control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2020
CompletedFirst Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 13, 2026
May 1, 2026
8 years
August 12, 2022
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)
EXPERIMENTALThe 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.
Interventions
Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- incarceration
- pregnancy
- inability to consent
- psychiatric comorbidity
- medical conditions that significantly increase the risk of adverse effects of general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University Orthopaedic Center
Salt Lake City, Utah, 84108, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Hutchinson, M.D.
University of Utah Orthopaedics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 17, 2022
Study Start
December 21, 2020
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
May 13, 2026
Record last verified: 2026-05