Studying Electromyographic Activity in Patients With Upper Limb Amputations

NCT02956603 | Completed

• 2 other identifiers: HUM00088547N66001-16-1-4006
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amputation, Traumatic

Outcome Measures

Primary Outcomes (2)

• Amplitude of EMG signal

  <4 hours

• Number of separate sensory percepts evoked

  <4 hours

Study Arms (3)

Neuroma Graft

EXPERIMENTAL

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

Prosthetic Control Graft

EXPERIMENTAL

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

Able Bodied

EXPERIMENTAL

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

Interventions

Fine wire EMG electrodes OTHER

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

Able Bodied; Neuroma Graft; Prosthetic Control Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For the prosthetic control graft arm:
• For the able-bodied arm:

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 7, 2016
• Study Start: September 6, 2015
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share