AmputationsNCT02034461
Micro-Electrodes Implanted in a Human Nerve
A study testing Utah Slanted Electrode Array in people with Amputations and Peripheral Nerve Injury, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputations, Peripheral Nerve Injury, Spinal Cord Injury
- What is being tested?
- Utah Slanted Electrode Array
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- incarceration
- pregnancy
- inability to consent
- psychiatric comorbidity
- increase the risk of adverse effects of general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
The University Orthopaedic Center
Salt Lake City, Utah, 84108
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 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
- Being tested
- Utah Slanted Electrode Array
- Keywords
- Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury
- Medical subject headings
- Peripheral Nerve Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utah Slanted Electrode ArrayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute surgical implantation | Experimental | The investigators will conduct 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 the PI with human surgical experience in implanting USEAs and evaluating the containment system the investigators will be using to immobilize the implanted USEA in the nerve. Receives: Device: Utah Slanted Electrode Array |
| Implantation of a Utah Electrode Array | Experimental | The arm which has been amputated or has peripheral nerve trauma. Intervention include insertion of the Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation. Receives: Device: Utah Slanted Electrode Array |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2021
- Study completionApr 2021
Why it stopped: This device feasibility study was using a microelectrode array device to determine viability of the product. Design and operating specification of the device were established. A new IDE trial has been initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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, Principal investigator, Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034461
- Sponsor's protocol ID
- 55621
- Status last verified
- Jul 2022
- First submitted
- 3 May 2013
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. 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
- NCT02034461
- Acronym / sponsor ID
- 55621
- Conditions
- Amputations, Peripheral Nerve Injury, Spinal Cord Injury
- Keywords
- Micro-Electrodes, Peripheral Nerve Injury, Amputation, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This device feasibility study was using a microelectrode array device to determine viability of the product. Design and operating specification of the device were established. A new IDE trial has been initiated.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 13 Jan 2014 (estimated)
- 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 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute surgical implantation | Experimental | Device: Utah Slanted Electrode ArrayThe investigators will conduct 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 the PI with human surgical experience in implanting USEAs and evaluating the containment system the investigators will be using to immobilize the implanted USEA in the nerve. |
| Implantation of a Utah Electrode Array | Experimental | Device: Utah Slanted Electrode ArrayThe arm which has been amputated or has peripheral nerve trauma. Intervention include insertion of the 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 (5 listed)
- 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
Key exclusion criteria (5 listed)
- incarceration
- pregnancy
- inability to consent
- psychiatric comorbidity
- 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 |
|---|---|---|
| Utah Slanted Electrode ArrayMicroelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations or peripheral nerve trauma. | Device | Acute surgical implantation, Implantation of a Utah Electrode Array |
Primary outcome
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.
Time frame: Up to 4 Week Follow-up
Device feasibility evaluation to confirm design and operating specifications of the device to collect action potentials from peripheral nerves.
Results and safety
The study was stopped early (reason given: This device feasibility study was using a microelectrode array device to determine viability of the product. Design and operating specification of the device were established. A new IDE trial has been initiated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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. This study is not recruiting at the moment.
Douglas Hutchinson principal investigator
Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Utah Slanted Electrode Array in people with Amputations and Peripheral Nerve Injury, 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 5 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: stopped early, as of the sponsor's last update on 7 Jul 2022. 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?
The study was stopped early (reason given: This device feasibility study was using a microelectrode array device to determine viability of the product. Design and operating specification of the device were established. A new IDE trial has been initiated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 4 Week 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 7 Jul 2022.