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Studying Electromyographic Activity in Patients With Upper Limb Amputations

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ClinicalTrials.gov Identifier: NCT02956603
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2016
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Cederna, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Amputation, Traumatic Other: Fine wire EMG electrodes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Studying Electromyographic Activity in Patients With Upper Limb Amputations
Study Start Date : November 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
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
Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate

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

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




Primary Outcome Measures :
  1. Amplitude of EMG signal [ Time Frame: <4 hours ]
  2. Number of separate sensory percepts evoked [ Time Frame: <4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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
  • 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:

  • 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
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Responsible Party: Paul Cederna, Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering, University of Michigan
ClinicalTrials.gov Identifier: NCT02956603    
Other Study ID Numbers: HUM00088547
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared
Additional relevant MeSH terms:
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Amputation, Traumatic
Wounds and Injuries