Neural Enabled Prosthesis for Upper Limb Amputees

Launched by UNIVERSITY OF ARKANSAS, FAYETTEVILLE · Feb 7, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of prosthetic hand called the Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system. The goal is to see if this advanced prosthetic can effectively help individuals who have lost an arm below the elbow (a condition known as unilateral transradial amputation) regain functionality and improve their everyday lives. The study is currently looking for participants aged 18 and older who have had this type of amputation for at least nine months, have a functional hand on the opposite side, and are willing to try using a myoelectric arm.

If you or someone you know qualifies and chooses to participate, you can expect to be involved in assessments at a research site that will help determine how well the prosthetic works for you. Participants will need to be U.S. citizens or permanent residents and must be able to get to the research locations. It's important to note that certain medical conditions, such as severe pain, neurological disorders, or recent infections, may disqualify someone from joining the study. Overall, this trial aims to explore new ways to enhance the quality of life for those living with limb loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Unilateral transradial amputation
• • 2. Amputation occurred 9 months ago or more
• • 3. Functional hand contralateral to the amputation
• • 4. Ability and willingness to use myoelectric arm (as determined by prosthetist)
• • 5. 18 years of age or older
• • 6. Ability to obtain transportation to the research site and the clinicians' offices
• • 7. U.S. citizen or permanent U.S. resident
• • 8. Signed the Informed Consent Form
• Exclusion Criteria:
• • 1. Absence of limb due to birth defect
• • 2. Evidence of denervation of the residual limb
• • 3. Phantom limb pain that is severe enough to impair or restrict activity
• • 4. 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)
• • 5. Visual impairment that would affect hand usage during experimental procedures
• • 6. History of chronic infections
• • 7. History of recurring ulcers or blisters on the residual limb
• • 8. Evidence of an active infection, non-healed ulcer, recent history of a healed ulcer (\< 3 months)
• • 9. Use of another implanted electrical device (such as a pacemaker or nerve stimulator)
• • 10. Undergoing diathermy therapy of the residual limb
• • 11. 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)
• • 12. Self-reported emotional or psychological disorders or history of drug or alcohol abuse or addiction
• • 13. Memory disorders or significant cognitive impairment (self-reported and/or clinical observation during consent and screening procedures)
• • 14. Moderate to severe chronic pain
• • 15. Pregnant or nursing
• • 16. Self-reported sensitivity to material derived from porcine source
• • 17. Enrolled in another investigational research study
• • 18. 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.