Amputation Arm and Hand, Unilateral RightNCT03432325
Neural Enabled Prosthesis for Upper Limb Amputees
A study testing Neural Enabled Prosthesis in people with Amputation Arm and Hand, Unilateral Right and Amputation Arm and Hand, Unilateral Left, run by University of Arkansas, Fayetteville at 2 sites in United States.
Trial summary
This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Arm and Hand, Unilateral Right, Amputation Arm and Hand, Unilateral Left, Prosthesis User
- What is being tested?
- Neural Enabled Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Dec 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-0001
University of Arkansas
Fayetteville, Arkansas, 72701
About this study
This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.
Read the 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.
- Conditions
- Amputation Arm and Hand, Unilateral Right, Amputation Arm and Hand, Unilateral Left, Prosthesis User
- Being tested
- Neural Enabled Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Enabled ProsthesisDevice
Surgically implanted neural enabled prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Neural Enabled Prosthesis | Experimental | Neural Enabled Prosthesis Treatment Group Receives: Device: Neural Enabled Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Neural Stimulation System
Documented as the number of treatment-related adverse events as assessed by CTCAE v4.0.
Measured: Up to 104 weeks - post-treatment
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline plus up to 104 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start14 Dec 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation Arm and Hand, Unilateral RightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), United States Department of Defense
- Responsible party
- Principal investigator, Ranu Jung, University of Arkansas, Fayetteville
- Investigators
- Ranu Jung, Ph.D., Principal investigator, University of Arkansas, FayettevillePaul Pasquina, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432325
- Sponsor's protocol ID
- NEP601
- Other IDs
- R01EB023261, CDMRP-E00915.1a, W81XWH1910839
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2018
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study is a feasibility study therefore data collected is being used to assess the feasibility of the system for future investigation.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Enabled Prosthesis for Upper Limb Amputees
- ClinicalTrials.gov ID
- NCT03432325
- Acronym / sponsor ID
- NEP601
- Conditions
- Amputation Arm and Hand, Unilateral Right, Amputation Arm and Hand, Unilateral Left, Prosthesis User
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), United States Department of Defense
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural Enabled Prosthesis | Experimental | Device: Neural Enabled ProsthesisNeural Enabled Prosthesis Treatment Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Enabled ProsthesisSurgically implanted neural enabled prosthesis | Device | Neural Enabled Prosthesis |
Primary outcome
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.
12 secondary outcomes
Efficacy: Functionality of implanted system components
Time frame: Up to 104 weeks - post-treatment
Efficacy: Elicited sensations
Time frame: Up to 104 weeks - post-treatment
Efficacy: Graded control
Time frame: Up to 104 weeks - post-treatment
Efficacy: Activity Measure for Upper Limb Amputees (AM-ULA)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Orthotics and Prosthetics User Survey - The Upper Extremity Functional Status (OPUS - UEFS)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Trinity Amputation and Prosthetics Experience Scales - Revised (TAPES-R)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: Groningen Questionnaire - Problems After Arm Amputation (GQ-PAAA)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: 12-Item Short Form Survey (SF-12)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Surveys: McGill Pain Questionnaire (MPQ)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA)
Time frame: Baseline plus up to 104 weeks post-treatment
Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP)
Time frame: Baseline plus up to 104 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. The study is a feasibility study therefore data collected is being used to assess the feasibility of the system for future investigation.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranu Jung, Ph.D. principal investigator
University of Arkansas, Fayetteville
Paul Pasquina, MD principal investigator
Uniformed Services University of the Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Enabled Prosthesis in people with Amputation Arm and Hand, Unilateral Right and Amputation Arm and Hand, Unilateral Left, run by University of Arkansas, Fayetteville at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Neural Stimulation System (time frame: Up to 104 weeks - post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.