Amputation, TraumaticNCT02956603
Studying Electromyographic Activity in Patients With Upper Limb Amputations
A study testing Fine wire EMG electrodes in people with Amputation, Traumatic, run by University of Michigan.
Trial summary
The primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation, Traumatic
- What is being tested?
- Fine wire EMG electrodes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2015to 12 Nov 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the prosthetic control graft arm:
- Must have previously undergone upper limb amputation
- Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
- Must be American Society of Anesthesiologists (ASA) Class I (low surgical risk)
- Must have sufficient soft tissue quality to support performance of the operative procedures
- Must have NOT previously received the partial muscle graft surgery
Show all 13Show fewer
- For the neuroma graft arm:
- Must have previously undergone upper limb amputation
- Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
- Must have previously received the partial muscle graft surgery
- For the able-bodied arm:
- Must have NOT undergone upper limb amputation
- Must be in good health
Who cannot join
- For the prosthetic control graft arm:
- Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring, may not be appropriate candidates for inclusion in the study
- For the able-bodied arm:
- Participants with a history of nerve pain may not be appropriate candidates for inclusion in the study
About this study
The primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by electrical stimulation.
- Conditions
- Amputation, Traumatic
- Being tested
- Fine wire EMG electrodes
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine wire EMG electrodesOther
Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate
| Study group | Role | What they receive |
|---|---|---|
| Neuroma Graft | Experimental | In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves. Receives: Other: Fine wire EMG electrodes |
| Prosthetic Control Graft | Experimental | In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves. Receives: Other: Fine wire EMG electrodes |
| Able Bodied | Experimental | The investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby. Receives: Other: Fine wire EMG electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of EMG signal
Measured: <4 hours
Number of separate sensory percepts evoked
Measured: <4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start6 Sep 2015
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Cederna, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956603
- Sponsor's protocol ID
- HUM00088547
- Other IDs
- N66001-16-1-4006
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2016
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Electromyographic Activity in Patients With Upper Limb Amputations
- ClinicalTrials.gov ID
- NCT02956603
- Acronym / sponsor ID
- HUM00088547
- Conditions
- Amputation, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 6 Sep 2015 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 7 Nov 2016 (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 primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by electrical stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuroma Graft | Experimental | Other: Fine wire EMG electrodesIn this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves. |
| Prosthetic Control Graft | Experimental | Other: Fine wire EMG electrodesIn this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves. |
| Able Bodied | Experimental | Other: Fine wire EMG electrodesThe investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For the prosthetic control graft arm:
- For the neuroma graft arm:
- For the able-bodied arm:
Key exclusion criteria (4 listed)
- For the prosthetic control graft arm:
- For the able-bodied arm:
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 |
|---|---|---|
| Fine wire EMG electrodesElectrodes placed either in partial muscle grafts or in intact muscle to record and stimulate | Other | Able Bodied, Neuroma Graft, Prosthetic Control Graft |
Primary outcome
Amplitude of EMG signal
Time frame: <4 hours
Number of separate sensory percepts evoked
Time frame: <4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
Related trials for Amputation, Traumatic
Recruiting
Transtibial Osseointegration
Amputation; Traumatic, Leg, Lower
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Pilot Trial for WounDx™ Clinical Decision Support Tool
Wounds, Wounds and Injuries
Recruiting
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Lower Limb Amputation, Prosthesis Users
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fine wire EMG electrodes in people with Amputation, Traumatic, run by University of Michigan.
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 13 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amplitude of EMG signal (time frame: <4 hours). The study lists 2 primary outcomes in all. 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 23 Jul 2024.