Neural Enabled Prosthesis for Upper Limb Amputees

University of Arkansas, Fayetteville

Status: Enrolling

Conditions: Amputation Arm and Hand, Unilateral Left; Amputation Arm and Hand, Unilateral Right; Prosthesis User

Treatments: Device: Neural Enabled Prosthesis

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03432325

R01EB023261 (U.S. NIH Grant/Contract)

CDMRP-E00915.1a (Other Identifier)

NEP601

W81XWH1910839 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate a new prosthetic system for transradial amputees called the neural-enabled prosthetic hand (ANS-NEPH). It is intended to provide the sense of touch, grasp force and hand opening to the user by sending electrical stimulation pulses to electrodes implanted in nerve fascicles in the upper arm of the residual limb. The system uses measurements from sensors in the prosthetic hand and wireless communication to the implanted neurostimulator to adjust the pulses continuously so that the user gets sensation as tasks are performed with the prosthesis.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Neural Enabled Prosthesis

Experimental group

Description:

Neural Enabled Prosthesis Treatment Group

Treatment:

Device: Neural Enabled Prosthesis