RecruitingNot ApplicableNCT03432325

Neural Enabled Prosthesis for Upper Limb Amputees


Sponsor

University of Arkansas, Fayetteville

Enrollment

15 participants

Start Date

Dec 14, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a neural-enabled prosthetic arm for people with a below-elbow (transradial) amputation. Unlike standard myoelectric prosthetics that pick up surface muscle signals, this advanced device uses implanted electrodes to interface directly with peripheral nerves in the residual limb. This allows more natural, intuitive control of the prosthetic hand and may also restore a sense of touch and proprioception (the feeling of where the hand is in space). The study involves a surgical procedure to implant electrodes, followed by extensive therapy and testing sessions to learn to use the new prosthesis. Participants must be U.S. citizens or permanent residents with a unilateral transradial amputation at least 9 months old. You may be eligible if: - You have a unilateral transradial (below-elbow) amputation that occurred at least 9 months ago - You are 18 years of age or older and a U.S. citizen or permanent resident - You have a functional contralateral (other) hand - A prosthetist has determined you have the ability and willingness to use a myoelectric arm - You have no evidence of denervation in the residual limb You may NOT be eligible if: - Your limb absence is due to a birth defect (not amputation) - You have severe phantom limb pain that impairs activity - You have nerve damage, neuropathy, or a neurological condition affecting the residual limb - You have a pacemaker or other implanted electrical device - You have chronic infections, recurring ulcers, or an active infection - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeural Enabled Prosthesis

Surgically implanted neural enabled prosthesis


Locations(2)

University of Arkansas

Fayetteville, Arkansas, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

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NCT03432325


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