Amputation NeuromaNCT03260400
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
A study testing a bipolar percutaneous intramuscular electromyography electrode in people with Amputation Neuroma and Amputation, run by University of Michigan at 1 site in United States.
Trial summary
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Amputation Neuroma, Amputation
- What is being tested?
- a bipolar percutaneous intramuscular electromyography electrode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 5 May 2029
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 22 years of age or older.
- Participants must have previously undergone an upper limb amputation proximal to the wrist or are scheduled to undergo an upper limb amputation proximal to the wrist.
- For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.
- Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).
- Participants must have reliable transportation.
- Participants must be able to attend at minimum 6 hours of experiments per month while electrodes remain implanted.
- Participants must be at least 6 months post-amputation.
- Participants who will receive an amputation at the same time as RPNI grafts and electrodes must be undergoing an elective amputation surgery where loss of useful function of the hand has occurred. They must be at least 6 months post-injury or failed limb salvage to participate.
Who cannot join
- Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.
- Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
- Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.
- Participants must not have used tobacco for at least one month prior to enrollment in the study.
- Participants must agree to not use tobacco for the duration of the study.
- Participants cannot have sustained bilateral upper extremity amputation.
Show all 11Show fewer
- Participants cannot be pregnant.
- Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.
- Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.
- Participants must not have an autoimmune condition which is not well controlled by medication.
- Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related
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
University of Michigan
Ann Arbor, Michigan, 48109
Paul Cederna, M.D.
About this study
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
Read the detailed description
This is a single center, 10 subject early feasibility study in which the primary objective is to ensure the safety of percutaneous intramuscular electrodes implanted in surgically-created RPNI constructs in subjects with upper limb amputation. This will be assessed with endpoints measuring participant pain levels, RPNI graft tissue health, electrode migration, and unanticipated adverse events associated with medium-term electrode implantation. The secondary objectives are to assess the efficacy of the electrodes in recording electromyographic signals from the RPNI grafts and in delivering electrical stimulation to the RPNI grafts to evoke sensory percepts. These will be assessed with endpoints measuring the signal quality of the recorded signals and the stimulation thresholds required to evoke sensory percepts.
This study will enroll people who have had upper limb amputations or are planning to have upper limb amputations. Each participant who does not already have RPNI grafts at the time of enrollment will have RPNI grafts implanted on branches or fascicles of nerves of the upper extremity. Several or all RPNI grafts will have a single bipolar electrode implanted in the muscle tissue, with the proximal end tunneled to a percutaneous exit point on the residual limb. Additional electrodes may be placed in innervated muscles in the residual limb, in order to provide a control comparison as well as to provide additional input during prosthesis control experiments. Electrodes will remain implanted for up to 10 years, with a minimum of 2 study visits per month to perform prosthesis control and sensory feedback experiments. Study endpoint will be assessed at a minimum of once per month while electrodes remain implanted. After a maximum of 10 years, electrodes will be explanted and the study ended after a 1 week follow-up.
The results of this study will inform the final design of the electrodes to be implanted long-term in RPNI grafts to provide an increased number of degrees of freedom for prosthetic control and sensory and proprioceptive feedback. This will drastically improve the functionality of the prosthesis, enhance the sense of embodiment of the prosthesis itself, and enable future investigation of a fully-implanted (non-percutaneous) prosthesis control system.
- Conditions
- Amputation Neuroma, Amputation
- Being tested
- a bipolar percutaneous intramuscular electromyography electrode
- Keywords
- RPNI, Regenerative Peripheral Nerve Interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a bipolar percutaneous intramuscular electromyography electrodeDevice
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
| Study group | Role | What they receive |
|---|---|---|
| New Grafts | Experimental | In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the participant will have a shorter surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After another healing period, experiments with prosthetic control and sensory feedback will begin. Receives: Device: a bipolar percutaneous intramuscular electromyography electrode |
| Existing Grafts | Experimental | In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The participant will have a short surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After a healing period, experiments with prosthetic control and sensory feedback will begin. Receives: Device: a bipolar percutaneous intramuscular electromyography electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Level as measured by SF-36
Pain will be assessed using the SF-36 survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. Two questions related to pain with a score closer to 0 means a pain increase
Measured: Baseline and monthly for up to 10 years postoperatively
Change in Pain Level as measured by LANSS survey
Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. A score greater than 12 indicates neuropathic pain.
Measured: Baseline and monthly for up to 10 years postoperatively
Change in Pain Level as measured by Phantom Limb Questionnaire
Phantom pain will be assessed using the Phantom Limb Questionnaire, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. This 9-item instrument measures phantom pain on a scale of 0-4, where 0-no pain at all and 4=very severe pain.
Measured: Baseline and monthly for up to 10 years postoperatively
RPNI tissue degeneration measured by pain scores
RPNI tissue degeneration will be assessed by changes in pain scores (see above) and measurements of recording efficacy.
Recording efficacy will be assessed using two signal quality measures:
- Peak-to-peak signal amplitude during maximum voluntary contraction
- Signal-to-noise ratio during maximum voluntary contraction
Measured: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
RPNI electrode migration assessed by changes recording in efficacy and ultrasound
Electrode migration outside of the implanted RPNI graft or muscle will be assessed by changes in recording efficacy, as described above, and by ultrasound examination as necessary. Electrode extrusion and implantation complications will be assessed by adverse events reported by both the participant and the study physicians. At each study visit, the participant will be asked to report any issues, and will have a basic examination of the affected limb performed by study physicians and/or trained staff.
Measured: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
Secondary outcomes (2)
EMG signal quality from RPNI grafts
Efficacy will be assessed, for each implanted electrode using two calculated signal quality measures: Peak-to-peak signal amplitude during maximum voluntary contraction and signal-to-noise ratio during maximum voluntary contraction.
Measured: Baseline and monthly for up to 10 years postoperatively
Stimulation Threshold of RPNI grafts
Stimulation data will be recorded at least once per month while electrodes remain implanted. Stimulation threshold will be determined using the range of sensory feedback necessary to evoke a sensory percept.
Measured: Baseline and monthly for up to 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start11 Dec 2017
- Primary completion5 May 2029 (estimated)
- Study completion5 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation NeuromaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Paul Cederna, University of Michigan
- Investigators
- Paul Cederna, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260400
- Sponsor's protocol ID
- HUM00124839
- Other IDs
- 5R01NS105132-05
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2017
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lee C, Vaskov AK, Gonzalez MA, Vu PP, Davis AJ, Cederna PS, Chestek CA, Gates DH. Use of regenerative peripheral nerve interfaces and intramuscular electrodes to improve prosthetic grasp selection: a case study. J Neural Eng. 2022 Nov 14;19(6):10.1088/1741-2552/ac9e1c. doi: 10.1088/1741-2552/ac9e1c.
PubMed 36317254
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
- ClinicalTrials.gov ID
- NCT03260400
- Acronym / sponsor ID
- HUM00124839
- Conditions
- Amputation Neuroma, Amputation
- Keywords
- RPNI, Regenerative Peripheral Nerve Interface
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 5 May 2029 (estimated)
- Study completion
- 5 May 2029 (estimated)
- First posted
- 24 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 device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
Detailed description
This is a single center, 10 subject early feasibility study in which the primary objective is to ensure the safety of percutaneous intramuscular electrodes implanted in surgically-created RPNI constructs in subjects with upper limb amputation. This will be assessed with endpoints measuring participant pain levels, RPNI graft tissue health, electrode migration, and unanticipated adverse events associated with medium-term electrode implantation. The secondary objectives are to assess the efficacy of the electrodes in recording electromyographic signals from the RPNI grafts and in delivering electrical stimulation to the RPNI grafts to evoke sensory percepts. These will be assessed with endpoints measuring the signal quality of the recorded signals and the stimulation thresholds required to evoke sensory percepts.
This study will enroll people who have had upper limb amputations or are planning to have upper limb amputations. Each participant who does not already have RPNI grafts at the time of enrollment will have RPNI grafts implanted on branches or fascicles of nerves of the upper extremity. Several or all RPNI grafts will have a single bipolar electrode implanted in the muscle tissue, with the proximal end tunneled to a percutaneous exit point on the residual limb. Additional electrodes may be placed in innervated muscles in the residual limb, in order to provide a control comparison as well as to provide additional input during prosthesis control experiments. Electrodes will remain implanted for up to 10 years, with a minimum of 2 study visits per month to perform prosthesis control and sensory feedback experiments. Study endpoint will be assessed at a minimum of once per month while electrodes remain implanted. After a maximum of 10 years, electrodes will be explanted and the study ended after a 1 week follow-up.
The results of this study will inform the final design of the electrodes to be implanted long-term in RPNI grafts to provide an increased number of degrees of freedom for prosthetic control and sensory and proprioceptive feedback. This will drastically improve the functionality of the prosthesis, enhance the sense of embodiment of the prosthesis itself, and enable future investigation of a fully-implanted (non-percutaneous) prosthesis control system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Grafts | Experimental | Device: a bipolar percutaneous intramuscular electromyography electrodeIn this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the participant will have a shorter surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After another healing period, experiments with prosthetic control and sensory feedback will begin. |
| Existing Grafts | Experimental | Device: a bipolar percutaneous intramuscular electromyography electrodeIn this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The participant will have a short surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After a healing period, experiments with prosthetic control and sensory feedback will begin. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be 22 years of age or older.
- Participants must have previously undergone an upper limb amputation proximal to the wrist or are scheduled to undergo an upper limb amputation proximal to the wrist.
- For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.
- Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).
- Participants must have reliable transportation.
Key exclusion criteria (11 listed)
- Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.
- Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
- Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.
- Participants must not have used tobacco for at least one month prior to enrollment in the study.
- Participants must agree to not use tobacco for the duration of the study.
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 |
|---|---|---|
| a bipolar percutaneous intramuscular electromyography electrodeThe device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands. | Device | Existing Grafts, New Grafts |
Primary outcome
Change in Pain Level as measured by SF-36
Time frame: Baseline and monthly for up to 10 years postoperatively
Pain will be assessed using the SF-36 survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. Two questions related to pain with a score closer to 0 means a pain increase
Change in Pain Level as measured by LANSS survey
Time frame: Baseline and monthly for up to 10 years postoperatively
Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. A score greater than 12 indicates neuropathic pain.
Change in Pain Level as measured by Phantom Limb Questionnaire
Time frame: Baseline and monthly for up to 10 years postoperatively
Phantom pain will be assessed using the Phantom Limb Questionnaire, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. This 9-item instrument measures phantom pain on a scale of 0-4, where 0-no pain at all and 4=very severe pain.
RPNI tissue degeneration measured by pain scores
Time frame: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
RPNI tissue degeneration will be assessed by changes in pain scores (see above) and measurements of recording efficacy. Recording efficacy will be assessed using two signal quality measures: 1. Peak-to-peak signal amplitude during maximum voluntary contraction 2. Signal-to-noise ratio during maximum voluntary contraction
RPNI electrode migration assessed by changes recording in efficacy and ultrasound
Time frame: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
Electrode migration outside of the implanted RPNI graft or muscle will be assessed by changes in recording efficacy, as described above, and by ultrasound examination as necessary. Electrode extrusion and implantation complications will be assessed by adverse events reported by both the participant and the study physicians. At each study visit, the participant will be asked to report any issues, and will have a basic examination of the affected limb performed by study physicians and/or trained staff.
2 secondary outcomes
EMG signal quality from RPNI grafts
Time frame: Baseline and monthly for up to 10 years postoperatively
Stimulation Threshold of RPNI grafts
Time frame: Baseline and monthly for up to 10 years postoperatively
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 18 Aug 2026.
- Derived from this study: PubMed 36317254Lee C, Vaskov AK, Gonzalez MA, Vu PP, Davis AJ, Cederna PS, Chestek CA, Gates DH. Use of regenerative peripheral nerve interfaces and intramuscular electrodes to improve prosthetic grasp selection: a case study. J Neural Eng. 2022 Nov 14;19(6):10.1088/1741-2552/ac9e1c. doi: 10.1088/1741-2552/ac9e1c.
- Individual participant dataSharing planned: No
Related trials for Amputation Neuroma
Not yet recruiting
Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation
Chronic Pain Due to Injury, Neuroma of Lower Limb
Active, not recruiting
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Symptomatic Neuroma, Amputation
RecruitingObservational study
Results of Nerve Surgery to Treat PostAmputation Pain
Amputation Neuroma
RecruitingPhase 2
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
Neuroma, Neuropathic Pain
Not yet recruiting
Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection
Pain Management, Pain
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.
Paul Cederna, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a bipolar percutaneous intramuscular electromyography electrode in people with Amputation Neuroma and Amputation, run by University of Michigan 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 8 inclusion and 11 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 18 Aug 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 Paul Cederna, M.D. (734-936-5885, cederna@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level as measured by SF-36 (time frame: Baseline and monthly for up to 10 years postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260400, which also lists 1 linked publication.
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 18 Aug 2026.