Neural Enabled Prosthesis for Upper Limb Amputees

• ClinicalTrials.gov Identifier: NCT03432325
• Recruitment Status: Recruiting
• First Posted: February 14, 2018
• Last Update Posted: May 4, 2021
• Sponsor: Ranu Jung PhD
• 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

Study Description

Brief Summary:

This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.

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

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Neural Enabled Prosthesis; Neural Enabled Prosthesis Treatment Group	Device: Neural Enabled Prosthesis; Surgically implanted neural enabled prosthesis

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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)
2. 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)
3. 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
4. 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
5. 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.
6. 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.
7. 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).
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Contacts

Contact: Clinical Research Coordinator; (305) 348-4782; ANSlab@fiu.edu

Locations

United States, Florida

Florida International University; Recruiting

Miami, Florida, United States, 33174

Contact: Clinical Research Coordinator 305-348-4782 ANSlab@fiu.edu

Principal Investigator: Ranu Jung, Ph.D.

Sponsors and Collaborators

Ranu Jung PhD

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

United States Department of Defense

More Information

Additional Information:

Adaptive Neural Systems Laboratory Website 

• Responsible Party: Ranu Jung PhD, Wallace H. Coulter Eminent Scholars Chair and Professor, Florida International University
• 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
• Last Update Posted: May 4, 2021
• Last Verified: April 2021

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