Studying Electromyographic Activity in Patients With Upper Limb Amputations

NCT ID: NCT02956603

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-06
• Study Completion Date: 2020-11-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fine wire EMG electrodes

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Fine wire EMG electrodes

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Fine wire EMG electrodes

Intervention Type: OTHER

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

Interventions

Fine wire EMG electrodes

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Paul Cederna

Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

N66001-16-1-4006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00088547

Identifier Type: -

Identifier Source: org_study_id