Neural Enabled Prosthesis for Upper Limb Amputees

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.

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 Florida International University and the
clinicians' offices located in Miami

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. Enrolled in another investigational research study

17. 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.