This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
Surgically implanted neural enabled prosthesis
University of Arkansas
Fayetteville, Arkansas, United States
RECRUITINGWalter Reed National Military Medical Center
Bethesda, Maryland, United States
RECRUITINGSafety of the Neural Stimulation System
Documented as the number of treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Up to 104 weeks - post-treatment
Efficacy: Functionality of implanted system components
Documented as the percentage of implanted electronic units fully operational and the percentage of electrodes intact (having measured impedance values \< OR = 30kΩ)
Time frame: Up to 104 weeks - post-treatment
Efficacy: Elicited sensations
Ability of the system to elicit graded sensations documented as the correlation between stimulation intensity (expressed as a percentage of the stimulation range) and reported intensity of the elicited sensation (expressed as a percentage of the range of elicited sensations)
Time frame: Up to 104 weeks - post-treatment
Efficacy: Graded control
The ability of the system to enable graded control of a prosthesis measured as the accuracy with which the subject can achieve a specified target level of grasp force or hand opening. Comparing performance with \& without sensory stimulation
Time frame: Up to 104 weeks - post-treatment
Efficacy: Activity Measure for Upper Limb Amputees (AM-ULA)
The ability of the system to facilitate completion of functional tasks documented by using the AM-ULA. Comparing performance with \& without sensory stimulation
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Orthotics and Prosthetics User Survey - The Upper Extremity Functional Status (OPUS - UEFS)
The UEFS is a 28-item self-report pertaining to an individual's performance of self-care and daily living skills using the prosthetic hand. UEFS has a 5-point Likert scale where Score Points are 0 = not able, 1 = difficult, 2 = easy, 3 = very easy scores are given. The survey will be used to document changes in participants' functional status and quality of life.
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Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Disabilities of the Arm, Shoulder, and Hand (DASH)
The DASH Outcome Measure is a 30-item (scored 1-5) self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The survey will be used to measure disability of the upper extremities, and monitor change or function over time.
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Trinity Amputation and Prosthetics Experience Scales - Revised (TAPES-R)
This outcome measure is a 54-item self-report, health-related QOL questionnaire. This survey will be used to measure psychosocial processes that are linked with adapting to a prosthesis, to the activity restrictions associated with wearing a prosthesis, and to satisfaction with the prosthesis. Only some sections of the complete version have been included in the survey documents. In specific, we will administer the Psychosocial Scale (15 items) and Satisfaction with the Prosthesis Scale (8 items).
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Groningen Questionnaire - Problems After Arm Amputation (GQ-PAAA)
The GQ\_PAAA is a 14-item self-report measurement. This survey will be used to document frequency of phantom limb sensation, phantom limb pain, and stump pain. A modified version of this measure has been included in the survey documents.
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: 12-Item Short Form Survey (SF-12)
This outcome measure is a 12-item self-report questionnaire that provides glimpses into mental and physical functioning and overall health-related-quality of life. This survey will be used to document health-related quality of life.
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: McGill Pain Questionnaire (MPQ)
This survey will be used to document the quality and intensity of pain that the participant is experiencing. Participants select a single word from each of the 20 groups and then describe their present pain intensity on a scale of 0 to 5.
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA)
We have developed this assessment to measure the phantom limb telescoping at the beginning and at the end of each session to track how the length of the phantom limb changes after stimulation within a session and across sessions as reported by the subject. Subjects report where the end of the phantom limb is by pointing at it with the other hand.
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP)
SHAP is a clinically validated hand function test developed to assess the effectiveness of upper limb prostheses. The SHAP is made up of 6 abstract objects and 14 Activities of Daily Living (ADL). Each task is timed by the subject and recorded on an assessment sheet by the assessor.
Time frame: Baseline plus up to 104 weeks post-treatment