search
Back to results

Studying Electromyographic Activity in Patients With Upper Limb Amputations

Primary Purpose

Amputation, Traumatic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fine wire EMG electrodes
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amputation, Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Neuroma Graft

    Prosthetic Control Graft

    Able Bodied

    Arm Description

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

    Amplitude of EMG signal
    Number of separate sensory percepts evoked

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2016
    Last Updated
    January 11, 2023
    Sponsor
    University of Michigan
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02956603
    Brief Title
    Studying Electromyographic Activity in Patients With Upper Limb Amputations
    Official Title
    Studying Electromyographic Activity in Patients With Upper Limb Amputations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amputation, Traumatic

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neuroma Graft
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Prosthetic Control Graft
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Able Bodied
    Arm Type
    Experimental
    Arm Description
    The investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby.
    Intervention Type
    Other
    Intervention Name(s)
    Fine wire EMG electrodes
    Intervention Description
    Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate
    Primary Outcome Measure Information:
    Title
    Amplitude of EMG signal
    Time Frame
    <4 hours
    Title
    Number of separate sensory percepts evoked
    Time Frame
    <4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be shared

    Learn more about this trial

    Studying Electromyographic Activity in Patients With Upper Limb Amputations

    We'll reach out to this number within 24 hrs