Neural Enabled Prosthesis for Upper Limb Amputees

Exclusion Criteria18

• Absence of limb due to birth defect
• Evidence of denervation of the residual limb
• Phantom limb pain that is severe enough to impair or restrict activity
• Any neurological condition affecting motor and/or sensory function that would interfere with use of the intact hand or residual limb (as determined by neurologist)
• Visual impairment that would affect hand usage during experimental procedures
• History of chronic infections
• History of recurring ulcers or blisters on the residual limb
• Evidence of an active infection, non-healed ulcer, recent history of a healed ulcer (\< 3 months)
• Use of another implanted electrical device (such as a pacemaker or nerve stimulator)
• Undergoing diathermy therapy of the residual limb
• History of non-compliance with medical or research procedures or any condition that would limit their ability to comply with study related procedures (self-reported)
• Self-reported emotional or psychological disorders or history of drug or alcohol abuse or addiction
• Memory disorders or significant cognitive impairment (self-reported and/or clinical observation during consent and screening procedures)
• Moderate to severe chronic pain
• Pregnant or nursing
• Self-reported sensitivity to material derived from porcine source
• Enrolled in another investigational research study
• Any medical or psychiatric condition not otherwise specified (such as uncontrolled high blood pressure, heart or lung disease, active infection, and serious metabolic disorders) that would expose the subject to unacceptable risk and/or limit their ability to perceive meaningful sensation from stimulation of the peripheral nerves of the residual limb.