Neural Enabled Prosthesis for Upper Limb Amputees
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ClinicalTrials.gov Identifier: NCT03432325 |
Recruitment Status :
Recruiting
First Posted : February 14, 2018
Last Update Posted : July 18, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amputation Arm and Hand, Unilateral Right Amputation Arm and Hand, Unilateral Left Prosthesis User | Device: Neural Enabled Prosthesis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Neural Enabled Prosthesis for Upper Limb Amputees |
Actual Study Start Date : | December 14, 2017 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Neural Enabled Prosthesis
Neural Enabled Prosthesis Treatment Group
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Device: Neural Enabled Prosthesis
Surgically implanted neural enabled prosthesis |
- 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.
- Efficacy: Functionality of implanted system components [ Time Frame: Up to 104 weeks - post-treatment ]Documented as the percentage of implanted electronic units fully operational and the percentage of electrodes intact (having measured impedance values < OR = 30kΩ)
- Efficacy: Elicited sensations [ Time Frame: Up to 104 weeks - post-treatment ]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)
- Efficacy: Graded control [ Time Frame: Up to 104 weeks - post-treatment ]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
- Efficacy: Activity Measure for Upper Limb Amputees (AM-ULA) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]The ability of the system to facilitate completion of functional tasks documented by using the AM-ULA. Comparing performance with & without sensory stimulation
- Clinical Surveys: Orthotics and Prosthetics User Survey - The Upper Extremity Functional Status (OPUS - UEFS) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.
- Clinical Surveys: Disabilities of the Arm, Shoulder, and Hand (DASH) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.
- Clinical Surveys: Trinity Amputation and Prosthetics Experience Scales - Revised (TAPES-R) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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).
- Clinical Surveys: Groningen Questionnaire - Problems After Arm Amputation (GQ-PAAA) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.
- Clinical Surveys: 12-Item Short Form Survey (SF-12) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.
- Clinical Surveys: McGill Pain Questionnaire (MPQ) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.
- Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.
- Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- 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
- Self-reported sensitivity to material derived from porcine source
- Enrolled in another investigational research study
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432325
Contact: Clinical Research Coordinator | (479) 718-2390 | Anslab@uark.edu |
United States, Arkansas | |
University of Arkansas | Recruiting |
Fayetteville, Arkansas, United States, 72701 | |
Contact: Clinical Research Coordinator 479-718-2390 Anslab@uark.edu | |
Principal Investigator: Ranu Jung, Ph.D. |
Principal Investigator: | Ranu Jung, Ph.D. | University of Arkansas, Fayetteville |
Responsible Party: | Ranu Jung, Executive Director and Endowed Chair for I3R, Distinguished Professor, Associate Vice Chancellor, University of Arkansas, Fayetteville |
ClinicalTrials.gov Identifier: | NCT03432325 |
Other Study ID Numbers: |
NEP601 R01EB023261 ( U.S. NIH Grant/Contract ) CDMRP-E00915.1a ( Other Identifier: Human Research Protection Office ) W81XWH1910839 ( Other Grant/Funding Number: USAMRAA ) |
First Posted: | February 14, 2018 Key Record Dates |
Last Update Posted: | July 18, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | The study is a feasibility study therefore data collected is being used to assess the feasibility of the system for future investigation. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |