Neural Enabled Prosthesis for Upper Limb Amputees
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Neural Enabled Prosthesis |
Neural Enabled Prosthesis Treatment Group |
|
Recruiting Locations
University of Arkansas
Fayetteville, Arkansas 72701
Fayetteville, Arkansas 72701
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-0001
Bethesda, Maryland 20889-0001
More Details
- NCT ID
- NCT03432325
- Status
- Recruiting
- Sponsor
- University of Arkansas, Fayetteville
Detailed 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.