Studying Electromyographic Activity in Patients With Upper Limb Amputations

January 11, 2023 updated by: Paul Cederna, University of Michigan
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00088547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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