ClinicalTrials.gg
CompletedNCT02956603Updated Jul 23, 2024

Studying Electromyographic Activity in Patients With Upper Limb Amputations

An interventional study of Fine wire EMG electrodes in Amputation, Traumatic, sponsored by University of Michigan. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by University of Michigan · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Sep 2015, registered Nov 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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 electrical stimulation.

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Conditions studied

  • Amputation, Traumatic

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03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's enrollment of 18 is above the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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
  • 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

Exclusion criteria

Exclusion criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Neuroma Graft

    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.

    Other: Fine wire EMG electrodes

  • Experimental
    Prosthetic Control Graft

    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.

    Other: Fine wire EMG electrodes

  • Experimental
    Able Bodied

    The investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby.

    Other: Fine wire EMG electrodes

Interventions

  • OtherFine wire EMG electrodes

    Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate

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What researchers measure

Primary outcomes

  1. Amplitude of EMG signal

    Time frame: <4 hours

  2. Number of separate sensory percepts evoked

    Time frame: <4 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02956603
Responsible party
Paul Cederna (Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering, University of Michigan) — Principal investigator
First posted
Nov 6, 2016
Start date
Sep 6, 2015
Primary completion
Nov 12, 2020
Completion
Nov 12, 2020
Last update
Jul 23, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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