Clinical trial NCT03432325: Neural Enabled Prosthesis for Upper Limb Amputees
Official title: Neural Enabled Prosthesis for Upper Limb Amputees
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation Arm and Hand, Unilateral Right
Amputation Arm and Hand, Unilateral Left
Prosthesis User
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: United States Department of Defense
First posted: 2018-02-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Safety of the Neural Stimulation System
timeFrame: Up to 104 weeks - post-treatment
Secondary outcomes:
measure: Efficacy: Functionality of implanted system components
timeFrame: Up to 104 weeks - post-treatment
measure: Efficacy: Elicited sensations
timeFrame: Up to 104 weeks - post-treatment
measure: Efficacy: Graded control
timeFrame: Up to 104 weeks - post-treatment
measure: Efficacy: Activity Measure for Upper Limb Amputees (AM-ULA)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Surveys: Orthotics and Prosthetics User Survey - The Upper Extremity Functional Status (OPUS - UEFS)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Surveys: Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Surveys: Trinity Amputation and Prosthetics Experience Scales - Revised (TAPES-R)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Surveys: Groningen Questionnaire - Problems After Arm Amputation (GQ-PAAA)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Surveys: 12-Item Short Form Survey (SF-12)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Surveys: McGill Pain Questionnaire (MPQ)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA)
timeFrame: Baseline plus up to 104 weeks post-treatment
measure: Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP)
timeFrame: Baseline plus up to 104 weeks post-treatment
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: University of Arkansas, Fayetteville
name: Ranu Jung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniformed Services University of the Health Sciences
name: Paul Pasquina, MD
role: PRINCIPAL_INVESTIGATOR
References: