Skip to main content
OpenTrials
Completed

NCT Number: NCT02956603

Studying Electromyographic Activity in Patients With Upper Limb Amputations

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amputation, Traumatic Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine wire EMG electrodes

Other

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

Primary outcomes

  1. Amplitude of EMG signal

    Time frame: <4 hours

  2. Number of separate sensory percepts evoked

    Time frame: <4 hours

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2016
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.