Studying Electromyographic Activity in Patients With Upper Limb Amputations

Study Overview
=================
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.

Official Title
-----------------
Studying Electromyographic Activity in Patients With Upper Limb Amputations

Conditions
-----------------
Amputation, Traumatic

Intervention / Treatment
-----------------
* Other: Fine wire EMG electrodes


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuroma Graft<br>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<br>* Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate<br>|
| Experimental: Prosthetic Control Graft<br>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<br>* Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate<br>|
| Experimental: Able Bodied<br>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<br>* Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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