Neural Enabled Prosthesis for Upper Limb Amputees
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation Arm and Hand, Unilateral Right
- Sponsor
- University of Arkansas, Fayetteville
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Safety of the Neural Stimulation System
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ranu Jung
Executive Director and Endowed Chair for I3R, Distinguished Professor, Associate Vice Chancellor
University of Arkansas, Fayetteville
Eligibility Criteria
Inclusion Criteria
- •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)
- •18 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Safety of the Neural Stimulation System
Time Frame: Up to 104 weeks - post-treatment
Documented as the number of treatment-related adverse events as assessed by CTCAE v4.0.
Secondary Outcomes
- Efficacy: Functionality of implanted system components(Up to 104 weeks - post-treatment)
- Efficacy: Graded control(Up to 104 weeks - post-treatment)
- Clinical Surveys: Disabilities of the Arm, Shoulder, and Hand (DASH)(Baseline plus up to 104 weeks post-treatment)
- Clinical Surveys: McGill Pain Questionnaire (MPQ)(Baseline plus up to 104 weeks post-treatment)
- Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP)(Baseline plus up to 104 weeks post-treatment)
- Efficacy: Elicited sensations(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: Trinity Amputation and Prosthetics Experience Scales - Revised (TAPES-R)(Baseline plus up to 104 weeks post-treatment)
- Clinical Surveys: 12-Item Short Form Survey (SF-12)(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)
- Clinical Surveys: Groningen Questionnaire - Problems After Arm Amputation (GQ-PAAA)(Baseline plus up to 104 weeks post-treatment)
- Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA)(Baseline plus up to 104 weeks post-treatment)