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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03432325
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