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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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 criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of the Neural Stimulation System

Timeframe: Up to 104 weeks - post-treatment

Trial details

NCT IDNCT03432325

SponsorUniversity of Arkansas, Fayetteville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Amputation Arm and Hand, Unilateral Right trials