AmputationNCT03259386
Movement and Sensation for Advanced Prosthetic Hands
An observational study of Amputation, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to learn more information about nerves. This study is also designed to learn how the information in nerves could be used to develop new prosthetic devices. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Microelectrode array
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2017to 24 Oct 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: These are patients that have previously undergone a transradial or transhumeral amputation.
Who may be able to join
- 1. Patient has previously undergone a transradial (below elbow) or transhumeral (above elbow) amputation.
Who cannot join
- Pregnancy
- Incarceration
- Inability to consent
- Serious, untreated comorbidity
- Patient is diagnosed with a medical condition(s) that seriously increase the risk of electrode implantation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Phoenix, Arizona, 85054
Arizona State University
Tempe, Arizona, 85287
About this study
Official title: Using Arrays of Microelectrodes Implanted in Residual Peripheral Nerves to Provide Dexterous Control of, and Modulated Sensory Feedback From, a Hand Prosthesis
The purpose of this study is to learn more information about nerves. This study is also designed to learn how the information in nerves could be used to develop new prosthetic devices.
Read the detailed description
The general design of the study is broken down into two parts: the pre- and post-implantation schedules:
During the 30 days before implantation the participant will be asked to take home a small computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be asked to use these items five (5) times a week for 30 minutes a session and interact with a displayed virtual reality environment. In this environment the participant will move their intact hand and the Leap Motion will display the hand movements in the virtual environment with the intact hand movements being mirrored between two hand facsimile. The participant will be instructed to move and stretch both their phantom and intact hand in a mirrored fashion. The purpose of these exercises are to allow the participant to become accustomed to the virtual reality setup (equipment and display) as well as providing a mirror box like effect where the virtual hand facsimile for their phantom hand is mapped to their body.
The second phase of the general design continues for 30-90 days post-implantation. We shall perform electrophysiological recordings from a single microelectrode array implanted into either the median, radial, or ulnar nerve. Neural signals (single and compound action potentials) evoked by variegated movements of the fingers and thumb will be recorded on the implanted microelectrode array. By recording electrical signals from the nerves the investigators hope to decode finger movements in real-time using machine learning algorithms. The participants will be asked to complete tasks in controlled virtual environment during the training phase. The virtual environment, which includes virtual arms and hands, will be presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task will require recording the position of arms in space which will be accomplished using the Vicon motion capture system that will use infra-red reflecting markers attached to the participant's arms. The investigators will also use a marker-less motion capture system, Leap Motion, to track the specific movements of the intact hand. Post training, the investigators aim to perform real-time decoding of finger movements in the virtual reality environments.
- Conditions
- Amputation
- Being tested
- Microelectrode array
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microelectrode arrayDevice
Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.
| Study group | Role | What they receive |
|---|---|---|
| Transradial or Transhumeral amputees | High-count microelectrode arrays are implanted into the upper limb peripheral nerves of transradial or transhumeral amputees. Receives: Device: Microelectrode array |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects for whom the investigators can decode finger movements
High-count microelectrode arrays are implanted into upper limb peripheral nerves of transradial and transhumeral amputees. Direct micro-stimulation of peripheral nerves will be done using the microelectrode array.
Measured: From 44-104 days post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start11 Sep 2017
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Why it stopped: Problem with obtaining microarrays, which are essential components needed to conduct this study.
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Arizona State University
- Responsible party
- Principal investigator, Shelley S. Noland, Mayo Clinic
- Investigators
- Shelley Noland, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259386
- Sponsor's protocol ID
- 14-007456
- Other IDs
- W81XWH-13-PRORP-TRA
- Status last verified
- Dec 2018
- First submitted
- 21 Aug 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Arrays of Microelectrodes Implanted in Residual Peripheral Nerves to Provide Dexterous Control of, and Modulated Sensory Feedback From, a Hand Prosthesis
- ClinicalTrials.gov ID
- NCT03259386
- Acronym / sponsor ID
- 14-007456
- Conditions
- Amputation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problem with obtaining microarrays, which are essential components needed to conduct this study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense, Arizona State University
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 23 Aug 2017 (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 purpose of this study is to learn more information about nerves. This study is also designed to learn how the information in nerves could be used to develop new prosthetic devices.
Detailed description
The general design of the study is broken down into two parts: the pre- and post-implantation schedules:
During the 30 days before implantation the participant will be asked to take home a small computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be asked to use these items five (5) times a week for 30 minutes a session and interact with a displayed virtual reality environment. In this environment the participant will move their intact hand and the Leap Motion will display the hand movements in the virtual environment with the intact hand movements being mirrored between two hand facsimile. The participant will be instructed to move and stretch both their phantom and intact hand in a mirrored fashion. The purpose of these exercises are to allow the participant to become accustomed to the virtual reality setup (equipment and display) as well as providing a mirror box like effect where the virtual hand facsimile for their phantom hand is mapped to their body.
The second phase of the general design continues for 30-90 days post-implantation. We shall perform electrophysiological recordings from a single microelectrode array implanted into either the median, radial, or ulnar nerve. Neural signals (single and compound action potentials) evoked by variegated movements of the fingers and thumb will be recorded on the implanted microelectrode array. By recording electrical signals from the nerves the investigators hope to decode finger movements in real-time using machine learning algorithms. The participants will be asked to complete tasks in controlled virtual environment during the training phase. The virtual environment, which includes virtual arms and hands, will be presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task will require recording the position of arms in space which will be accomplished using the Vicon motion capture system that will use infra-red reflecting markers attached to the participant's arms. The investigators will also use a marker-less motion capture system, Leap Motion, to track the specific movements of the intact hand. Post training, the investigators aim to perform real-time decoding of finger movements in the virtual reality environments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transradial or Transhumeral amputees | – | Device: Microelectrode arrayHigh-count microelectrode arrays are implanted into the upper limb peripheral nerves of transradial or transhumeral amputees. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- These are patients that have previously undergone a transradial or transhumeral amputation.
Key inclusion criteria (1 listed)
- 1. Patient has previously undergone a transradial (below elbow) or transhumeral (above elbow) amputation.
Key exclusion criteria (5 listed)
- Pregnancy
- Incarceration
- Inability to consent
- Serious, untreated comorbidity
- Patient is diagnosed with a medical condition(s) that seriously increase the risk of electrode implantation
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 |
|---|---|---|
| Microelectrode arrayMicroelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research. | Device | Transradial or Transhumeral amputees |
Primary outcome
Number of subjects for whom the investigators can decode finger movements
Time frame: From 44-104 days post-implantation
High-count microelectrode arrays are implanted into upper limb peripheral nerves of transradial and transhumeral amputees. Direct micro-stimulation of peripheral nerves will be done using the microelectrode array.
Results and safety
The study was stopped early (reason given: Problem with obtaining microarrays, which are essential components needed to conduct this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
Shelley Noland, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Mayo Clinic at 2 sites 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 1 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Problem with obtaining microarrays, which are essential components needed to conduct this study.). 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?
Number of subjects for whom the investigators can decode finger movements (time frame: From 44-104 days post-implantation). 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 11 Dec 2018; AzTrials last refreshed its copy on 29 Oct 2026.