Neural-enabled prosthetic hand for upper limb amputees
Neural Enabled Prosthesis for Upper Limb Amputees
This study is testing a new prosthetic hand that helps people with lower arm amputations feel touch and control their grip better by using special sensors and electrical stimulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arkansas, Fayetteville Academic / other |
| Locations | 2 sites (Fayetteville, Arkansas and 1 other locations) |
| Trial ID | NCT03432325 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of the Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system designed for transradial amputees. The prosthetic hand aims to restore the sense of touch, grasp force, and hand opening by delivering electrical stimulation to electrodes implanted in the residual limb's nerve fascicles. Using sensor measurements from the prosthetic hand, the system continuously adjusts stimulation pulses to provide real-time sensory feedback as users perform tasks. The goal is to enhance the functionality and user experience of prosthetic devices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with unilateral transradial amputations that occurred at least 9 months prior.
Not a fit: Patients with congenital limb absence or severe neurological conditions affecting motor and sensory function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for upper limb amputees by restoring sensory feedback and enhancing prosthetic functionality.
How similar studies have performed: Other studies have shown promise in developing sensory feedback systems for prosthetics, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Unilateral transradial amputation 2. Amputation occurred 9 months ago or more 3. Functional hand contralateral to the amputation 4. Ability and willingness to use myoelectric arm (as determined by prosthetist) 5. 18 years of age or older 6. Ability to obtain transportation to the research site and the clinicians' offices 7. U.S. citizen or permanent U.S. resident 8. Signed the Informed Consent Form Exclusion Criteria: 1. Absence of limb due to birth defect 2. Evidence of denervation of the residual limb 3. Phantom limb pain that is severe enough to impair or restrict activity 4. 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) 5. Visual impairment that would affect hand usage during experimental procedures 6. History of chronic infections 7. History of recurring ulcers or blisters on the residual limb 8. Evidence of an active infection, non-healed ulcer, recent history of a healed ulcer (\< 3 months) 9. Use of another implanted electrical device (such as a pacemaker or nerve stimulator) 10. Undergoing diathermy therapy of the residual limb 11. 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) 12. Self-reported emotional or psychological disorders or history of drug or alcohol abuse or addiction 13. Memory disorders or significant cognitive impairment (self-reported and/or clinical observation during consent and screening procedures) 14. Moderate to severe chronic pain 15. Pregnant or nursing 16. Self-reported sensitivity to material derived from porcine source 17. Enrolled in another investigational research study 18. 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.
Where this trial is running
Fayetteville, Arkansas and 1 other locations
- University of Arkansas — Fayetteville, Arkansas, United States (Recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ranu Jung, Ph.D. — University of Arkansas, Fayetteville
- Study coordinator: Clinical Research Coordinator
- Email: Anslab@uark.edu
- Phone: (479) 718-2390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.