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Neural Enabled Prosthesis for Upper Limb Amputees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432325
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : May 4, 2021
Sponsor:
Collaborators:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
United States Department of Defense
Information provided by (Responsible Party):
Ranu Jung PhD, Florida International University

Tracking Information
First Submitted Date  ICMJE January 5, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE December 14, 2017
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
Safety of the Neural Stimulation System [ Time Frame: Up to 104 weeks ]
Documented as the number of treatment-related adverse events as assessed by CTCAE v4.0.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
  • Efficacy: Functionality of implanted system components [ Time Frame: Up to 104 weeks ]
    Documented as the percentage of implanted electronic units fully operational and the percentage of electrodes intact (having measured impedance values < 15kΩ)
  • Efficacy: Elicited sensations [ Time Frame: Up to 104 weeks ]
    Ability of the system to elicit graded sensations documented as the goodness of fit of the relationship 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 ]
    The ability of the system to enable graded control of a prosthesis measured as the time taken to 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: Up to 104 weeks ]
    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: Up to 104 weeks ]
    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: Up to 104 weeks ]
    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: Up to 104 weeks ]
    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: Up to 104 weeks ]
    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: Up to 104 weeks ]
    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: Up to 104 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Enabled Prosthesis for Upper Limb Amputees
Official Title  ICMJE Neural Enabled Prosthesis for Upper Limb Amputees
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Amputation Arm and Hand, Unilateral Right
  • Amputation Arm and Hand, Unilateral Left
  • Prosthesis User
Intervention  ICMJE Device: Neural Enabled Prosthesis
Surgically implanted neural enabled prosthesis
Study Arms  ICMJE Experimental: Neural Enabled Prosthesis
Neural Enabled Prosthesis Treatment Group
Intervention: Device: Neural Enabled Prosthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Florida International University and the clinicians' offices located in Miami
  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. Enrolled in another investigational research study
  17. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Research Coordinator (305) 348-4782 ANSlab@fiu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03432325
Other Study ID Numbers  ICMJE NEP601
R01EB023261 ( U.S. NIH Grant/Contract )
CDMRP-E00915.1a ( Other Identifier: Human Research Protection Office )
W81XWH1910839 ( Other Grant/Funding Number: USAMRAA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Ranu Jung PhD, Florida International University
Study Sponsor  ICMJE Ranu Jung PhD
Collaborators  ICMJE
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • United States Department of Defense
Investigators  ICMJE Not Provided
PRS Account Florida International University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP