Neural Enabled Prosthesis for Upper Limb Amputees

Description

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

Conditions

Amputation Arm and Hand, Unilateral Right, Amputation Arm and Hand, Unilateral Left, Prosthesis User

Study Overview

Study Details

Study overview

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

Neural Enabled Prosthesis for Upper Limb Amputees

Neural Enabled Prosthesis for Upper Limb Amputees

Condition
Amputation Arm and Hand, Unilateral Right
Intervention / Treatment

-

Contacts and Locations

Fayetteville

University of Arkansas, Fayetteville, Arkansas, United States, 72701

Bethesda

Walter Reed National Military Medical Center, Bethesda, Maryland, United States, 20889-0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Arkansas, Fayetteville,

Ranu Jung, Ph.D., PRINCIPAL_INVESTIGATOR, University of Arkansas, Fayetteville

Paul Pasquina, MD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

2025-12-31