Studying Electromyographic Activity in Patients With Upper Limb Amputations

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2023

Interventions

  • Other: Fine wire EMG electrodes
    • Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Amplitude of EMG signal
    • Time Frame: <4 hours
  • Number of separate sensory percepts evoked
    • Time Frame: <4 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paul Cederna, Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering – University of Michigan

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