RECRUITING

Neural Enabled Prosthesis for Upper Limb Amputees

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Neural Enabled Prosthesis for Upper Limb Amputees

Quick Facts

Study Start:2017-12-14

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03432325

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Clinical Research Coordinator

CONTACT

(479) 718-2390

Anslab@uark.edu

Principal Investigator

Ranu Jung, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Arkansas, Fayetteville

Paul Pasquina, MD

PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Study Locations (Sites)

University of Arkansas

Fayetteville, Arkansas, 72701

United States

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-0001

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-14

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2017-12-14

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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