AmputationNCT05505513
Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
A study testing percutaneous Utah Slanted Electrode Arrays (pUSEAs) in people with Amputation, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- percutaneous Utah Slanted Electrode Arrays (pUSEAs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- incarceration
- pregnancy
- inability to consent
- psychiatric comorbidity
- medical conditions that significantly increase the risk of adverse effects of general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University Orthopaedic Center
Salt Lake City, Utah, 84108
Douglas Hutchinson, M.D., 801-587-5453
About this study
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?
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.
Read the 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., wrist, and individually moving digits. These studies will also investigate to what extent microstimulation can provide sensory feedback from a prosthetic limb.
The HAPTIX System study will investigate the safety and efficacy of using electromyography (EMG), plus neural recording and nerve stimulation, to control and provide cutaneous and proprioceptive feedback from a dexterous, motorized and sensorized, upper-extremity prosthesis (e.g., the DEKA LUKE arm) used by amputees.
The HAPTIX System is intended to permit the function of an upper-extremity prosthesis to assist in activities of daily living (ADLs) using neurostimulation and recording of EMG and neural signals to control the prosthesis, and evoke touch sensation and proprioception in upper-extremity amputees with DEKA LUKE sensorized upper extremity prosthesis.
The HAPTIX System study is an early feasibility study (EFS) of the use of a combination of EMG recording electrodes, neural recording and stimulating electrodes, and external electronics and algorithms designed to provide sensory and proprioceptive feedback to the amputee, and to control movements of a prosthetic hand.
EMG signals from the residual forearm muscles of amputees will be recorded using up to 8 custom bipolar PermaLoc® electrodes. The incorporation of these electrodes into the HAPTIX System is described in 001_G190131A002_Amended_Device Description. Nerve signals will also be recorded using up to 3 percutaneous Utah Slanted Electrode Arrays (pUSEAs), whose electrode tips will be implanted intrafascicularly in residual arm nerves. Present-version pUSEAs utilize a transcutaneous lead and extracorporeal connector. Motor signals from the nerve will contribute to decoding motor intents decoded to control an advanced prosthetic hand. Nerve stimulation to evoke sensory perceptions will be provided by passing current through individual pUSEA electrodes, separately or in combination.
- Conditions
- Amputation
- Being tested
- percutaneous Utah Slanted Electrode Arrays (pUSEAs)
- Keywords
- Micro-Electrodes, Amputation, Prosthetic Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous Utah Slanted Electrode Arrays (pUSEAs)Device
Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs) | Experimental | 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. Receives: Device: percutaneous Utah Slanted Electrode Arrays (pUSEAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2-years Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start21 Dec 2020
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Hutchinson, University of Utah
- Investigators
- Douglas Hutchinson, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505513
- Sponsor's protocol ID
- 124231
- Status last verified
- May 2026
- First submitted
- 12 Aug 2022
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05505513
- Acronym / sponsor ID
- 124231
- Conditions
- Amputation
- Keywords
- Micro-Electrodes, Amputation, Prosthetic Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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., wrist, and individually moving digits. These studies will also investigate to what extent microstimulation can provide sensory feedback from a prosthetic limb.
The HAPTIX System study will investigate the safety and efficacy of using electromyography (EMG), plus neural recording and nerve stimulation, to control and provide cutaneous and proprioceptive feedback from a dexterous, motorized and sensorized, upper-extremity prosthesis (e.g., the DEKA LUKE arm) used by amputees.
The HAPTIX System is intended to permit the function of an upper-extremity prosthesis to assist in activities of daily living (ADLs) using neurostimulation and recording of EMG and neural signals to control the prosthesis, and evoke touch sensation and proprioception in upper-extremity amputees with DEKA LUKE sensorized upper extremity prosthesis.
The HAPTIX System study is an early feasibility study (EFS) of the use of a combination of EMG recording electrodes, neural recording and stimulating electrodes, and external electronics and algorithms designed to provide sensory and proprioceptive feedback to the amputee, and to control movements of a prosthetic hand.
EMG signals from the residual forearm muscles of amputees will be recorded using up to 8 custom bipolar PermaLoc® electrodes. The incorporation of these electrodes into the HAPTIX System is described in 001_G190131A002_Amended_Device Description. Nerve signals will also be recorded using up to 3 percutaneous Utah Slanted Electrode Arrays (pUSEAs), whose electrode tips will be implanted intrafascicularly in residual arm nerves. Present-version pUSEAs utilize a transcutaneous lead and extracorporeal connector. Motor signals from the nerve will contribute to decoding motor intents decoded to control an advanced prosthetic hand. Nerve stimulation to evoke sensory perceptions will be provided by passing current through individual pUSEA electrodes, separately or in combination.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- incarceration
- pregnancy
- inability to consent
- psychiatric comorbidity
- medical conditions that significantly increase the risk of adverse effects of general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs) |
Primary outcome
Measure Action Potentials (millivolts, mV)
Time frame: Up to 2-years Follow-up
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas Hutchinson, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous Utah Slanted Electrode Arrays (pUSEAs) in people with Amputation, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douglas Hutchinson, M.D. (801-587-5400, Douglas.Hutchinson@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Action Potentials (millivolts, mV) (time frame: Up to 2-years Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.