Neural Enabled Prosthesis for Upper Limb Amputees

NCT ID: NCT03432325

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2025-12-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Neural Enabled Prosthesis

Neural Enabled Prosthesis Treatment Group

Group Type: EXPERIMENTAL

Neural Enabled Prosthesis

Intervention Type: DEVICE

Surgically implanted neural enabled prosthesis

Interventions

Neural Enabled Prosthesis

Surgically implanted neural enabled prosthesis

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

University of Arkansas, Fayetteville

OTHER

Sponsor Role: lead

Responsible Party

Ranu Jung

Executive Director and Endowed Chair for I3R, Distinguished Professor, Associate Vice Chancellor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranu Jung, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas, Fayetteville

Paul Pasquina, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

University of Arkansas

Fayetteville, Arkansas, United States

Site Status: RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Research Coordinator

Role: CONTACT

Anslab@uark.edu

(479) 718-2390

Facility Contacts

Clinical Research Coordinator

Role: primary

Anslab@uark.edu

479-718-2390

CRSR Research Team

Role: primary

CRSC_Research@usuhs.edu

301-550-0509

Other Identifiers

R01EB023261

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDMRP-E00915.1a

Identifier Type: OTHER

Identifier Source: secondary_id

W81XWH1910839

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NEP601

Identifier Type: -

Identifier Source: org_study_id