Studying Electromyographic Activity in Patients With Upper Limb Amputations

University of Michigan

Status: Completed

Conditions: Amputation, Traumatic

Treatments: Other: Fine wire EMG electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT02956603

N66001-16-1-4006 (Other Grant/Funding Number)

HUM00088547

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Neuroma Graft

Experimental group

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.

Treatment:

Other: Fine wire EMG electrodes

Prosthetic Control Graft

Experimental group

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.

Treatment:

Other: Fine wire EMG electrodes

Able Bodied

Experimental group

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.

Treatment:

Other: Fine wire EMG electrodes