Neural Enabled Prosthesis for Upper Limb Amputees

NCT03432325 | Active Not Recruiting FDA Device

• 4 other identifiers: NEP601R01EB023261CDMRP-E00915.1aW81XWH1910839
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Safety of the Neural Stimulation System

  Documented as the number of treatment-related adverse events as assessed by CTCAE v4.0.

  Up to 104 weeks - post-treatment

Secondary Outcomes (12)

• Efficacy: Functionality of implanted system components

  Up to 104 weeks - post-treatment

• Efficacy: Elicited sensations

  Up to 104 weeks - post-treatment

• Efficacy: Graded control

  Up to 104 weeks - post-treatment

• Efficacy: Activity Measure for Upper Limb Amputees (AM-ULA)

  Baseline plus up to 104 weeks post-treatment

• Clinical Surveys: Orthotics and Prosthetics User Survey - The Upper Extremity Functional Status (OPUS - UEFS)

  Baseline plus up to 104 weeks post-treatment

Study Arms (1)

Neural Enabled Prosthesis

EXPERIMENTAL

Neural Enabled Prosthesis Treatment Group

Device: Neural Enabled Prosthesis

Interventions

Neural Enabled Prosthesis DEVICE

Surgically implanted neural enabled prosthesis

Neural Enabled Prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transradial amputation
• Amputation occurred 9 months ago or more
• Functional hand contralateral to the amputation
• Ability and willingness to use myoelectric arm (as determined by prosthetist)
• years of age or older
• Ability to obtain transportation to the research site and the clinicians' offices
• U.S. citizen or permanent U.S. resident
• Signed the Informed Consent Form

You may not qualify if:

• Absence of limb due to birth defect
• Evidence of denervation of the residual limb
• Phantom limb pain that is severe enough to impair or restrict activity
• 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)
• Visual impairment that would affect hand usage during experimental procedures
• History of chronic infections
• History of recurring ulcers or blisters on the residual limb
• Evidence of an active infection, non-healed ulcer, recent history of a healed ulcer (\< 3 months)
• Use of another implanted electrical device (such as a pacemaker or nerve stimulator)
• Undergoing diathermy therapy of the residual limb
• 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)
• Self-reported emotional or psychological disorders or history of drug or alcohol abuse or addiction
• Memory disorders or significant cognitive impairment (self-reported and/or clinical observation during consent and screening procedures)
• Moderate to severe chronic pain
• Pregnant or nursing

Sponsors & Collaborators

• United States Department of Defense: collaborator
• University of Arkansas, Fayetteville: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (2)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-0001, United States

Location

Study Officials

• Ranu Jung, Ph.D.

  University of Arkansas, Fayetteville

  PRINCIPAL INVESTIGATOR

• Paul Pasquina, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director and Endowed Chair for I3R, Distinguished Professor, Associate Vice Chancellor

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 14, 2018
• Study Start: December 14, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)