Active — Not RecruitingNot Applicable

Neural Enabled Prosthesis for Upper Limb Amputees

United States15 participantsStarted 2017-12-14

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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)

Safety of the Neural Stimulation System

Timeframe: Up to 104 weeks - post-treatment

NCT IDNCT03432325

SponsorUniversity of Arkansas, Fayetteville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31