Status:
RECRUITING
Neural Enabled Prosthesis for Upper Limb Amputees
Lead Sponsor:
University of Arkansas, Fayetteville
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
United States Department of Defense
Conditions:
Amputation Arm and Hand, Unilateral Right
Amputation Arm and Hand, Unilateral Left
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.
Detailed Description
The purpose of this study is to evaluate a new prosthetic system for transradial amputees called the neural-enabled prosthetic hand (ANS-NEPH). It is intended to provide the sense of touch, grasp forc...
Eligibility Criteria
Inclusion
- Unilateral transradial amputation
- Amputation occurred 9 months ago or more
- Functional hand contralateral to the amputation
- Ability and willingness to use myoelectric arm (as determined by prosthetist)
- 18 years of age or older
- Ability to obtain transportation to the research site and the clinicians' offices
- U.S. citizen or permanent U.S. resident
- Signed the Informed Consent Form
Exclusion
- 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.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03432325
Start Date
December 14 2017
End Date
December 31 2025
Last Update
May 16 2024
Active Locations (2)
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1
University of Arkansas
Fayetteville, Arkansas, United States, 72701
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-0001