Neural Enabled Prosthesis for Upper Limb Amputation

Recruiting at 2 trial locations

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ranu Jung PhD

Disqualifiers: Neurological conditions, Chronic infections, Emotional disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new prosthetic hand system called the Neural Enabled Prosthesis, which connects to nerves to assist people with upper limb amputations. The goal is to determine if this advanced prosthesis can function effectively and feel more natural for users. Ideal candidates have had a below-elbow amputation more than nine months ago, possess a working hand on the opposite side, and are willing to try using a prosthetic arm. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance prosthetic technology for future users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a condition that could interfere with the study, it might be necessary to adjust your medications.

What prior data suggests that the Neural Enabled Prosthesis is safe for use in upper limb amputation?

Research has shown that the Neural Enabled Prosthesis is being tested for safety and effectiveness in people with upper limb amputations. So far, three individuals with such amputations have participated in the trial. The system reliably picked up signals from the body, which is crucial for proper functioning.

While this study doesn't provide detailed safety data, researchers are closely monitoring any possible side effects and how well participants can handle the device. This focus ensures the device's safety. Although specific information about side effects isn't available, the study's existence suggests some confidence in the system's basic safety.

Prospective participants should ask researchers about any known side effects or risks identified so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Neural Enabled Prosthesis is unique because it directly interfaces with the nervous system to provide more intuitive control and sensory feedback for individuals with upper limb amputations. Traditional prosthetics often rely on mechanical controls and can feel cumbersome. In contrast, this advanced prosthetic offers a more natural connection by using neural signals to operate, potentially improving both the functionality and the user experience. Researchers are excited because it represents a significant step toward prosthetics that feel and operate more like natural limbs, enhancing both the quality of life and the independence of users.

What evidence suggests that the Neural Enabled Prosthesis is effective for upper limb amputation?

Research has shown that the Neural Enabled Prosthesis, which participants in this trial will receive, uses advanced technology to connect directly with the nervous system. This connection helps individuals with upper limb amputations gain better control and sensation in their prosthetic limbs. Users of similar devices, known as myoelectric prostheses, have performed everyday tasks more easily and naturally. Early results indicate that this new prosthesis could enhance hand function and make using the artificial limb feel more natural. This development holds promise for improving the quality of life for amputees. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul Pasquina, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Ranu Jung, Ph.D.

Principal Investigator

University of Arkansas, Fayetteville

Are You a Good Fit for This Trial?

This trial is for U.S. residents aged 18 or older who have had a unilateral left arm and hand amputation at least 9 months ago, can use a myoelectric arm, and have a functional opposite hand. Participants must be able to travel to the research site, not have limb loss from birth defects, no severe infections or chronic pain, not pregnant/nursing, and without cognitive impairments that affect compliance.

Inclusion Criteria

You are able and willing to use a prosthetic arm that is controlled by muscle activity (determined by a prosthetist).

Ability to obtain transportation to the research site and the clinicians' offices

U.S. citizen or permanent U.S. resident

Exclusion Criteria

You were born without a limb.

You have reported being sensitive or allergic to materials that come from pigs.

Evidence of denervation of the residual limb

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Neural Enabled Prosthetic Hand (ANS-NEPH) system, which provides sensory feedback through electrical stimulation to electrodes implanted in the upper arm.

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of functionality, sensation, and quality of life.

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neural Enabled Prosthesis

Trial Overview The study tests the Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system's feasibility for individuals with an upper limb amputation. It aims to see how well participants can control this advanced prosthesis which uses neural inputs.

How Is the Trial Designed?

Group I: Neural Enabled Prosthesis Experimental Treatment 1 Intervention

Neural Enabled Prosthesis Treatment Group

Neural Enabled Prosthesis is already approved in United States for the following indications:

Approved in United States as ANS-NEPH for:

• Upper limb amputations

Who Is Running the Clinical Trial?

Ranu Jung PhD

Lead Sponsor

Trials

1

Recruited

20+

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A new technology platform combining bioelectronics and AI allows for high-accuracy control of prosthetic hands, enabling up to 15 degrees of freedom in movement, which is a significant improvement for amputees.

The system uses a neural interface that decodes motor intention from peripheral nerves, providing an intuitive way for users to control their prosthetic hands, making it feel more natural and effective in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bioelectric neural interface towards intuitive prosthetic control for amputees. Nguyen, AT., Xu, J., Jiang, M., et al.[2022]

The environmental scan identified four main integration methods for upper limb prostheses: osseointegration, targeted muscle reinnervation, cortical integration, and peripheral nerve/muscle integration, with targeted muscle reinnervation being the most researched.

User perspectives highlight a significant gap in user-centered research, emphasizing the need for better understanding of end-user preferences and the importance of maintaining future options in prosthetic device choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the benefits and risks of emerging integration methods for upper limb prosthetic devices in the United States: an environmental scan. Kelley, MA., Benz, H., Engdahl, S., et al.[2019]

Recent advancements in upper limb prostheses aim to restore sensory feedback to amputees, enhancing their control over the prosthetic and improving their sense of body ownership.

Prosthetic sensors convert environmental information into electrical signals, which can help identify textures and stiffness, allowing for partial restoration of sensory perception and more natural use of the prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Developments in Prosthesis Sensors, Texture Recognition, and Sensory Stimulation for Upper Limb Prostheses. Masteller, A., Sankar, S., Kim, HB., et al.[2021]

Recent studies highlight the development of advanced neuroprosthetic systems that integrate sensory feedback through direct nerve stimulation, enhancing the control of prosthetic arm and hand movements.

Future prosthetic technologies may include osseointegration and implanted electrodes for muscle and nerve stimulation, potentially improving functionality and accessibility for a larger patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bionic limbs: clinical reality and academic promises. Farina, D., Aszmann, O.[2018]

Neural prostheses use electrical stimulation to activate the nervous system, enabling restoration of functions in individuals with neurological impairments, such as hand movement in quadriplegics and bladder control after spinal cord injuries.

These devices have shown promising outcomes in both experimental and commercial applications, significantly improving independence and quality of life for users by restoring essential motor and sensory functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetic applications of electrical stimulation. Grill, WM., Kirsch, RF.[2008]

The clinical implementation of a transradial neuromusculoskeletal prosthesis in a patient with below-elbow amputation demonstrated improved prosthetic function and quality of life through direct connection to the user's nervous and skeletal systems.

The bionic hand allowed for reliable control and sensory feedback, with sensations from neural stimulation perceived on the phantom hand, indicating a significant advancement in prosthetic technology for everyday use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A highly integrated bionic hand with neural control and feedback for use in daily life. Ortiz-Catalan, M., Zbinden, J., Millenaar, J., et al.[2023]

Functional electrical stimulation is effectively used to activate paralyzed muscles, enabling movements like hand-grasp, and is enhanced by sensory feedback from peripheral nerves to improve control.

Advancements in neural prosthetics, including non-invasive brain recordings, show promise for restoring near-normal limb movement, with preliminary success observed in experimental animals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural prosthetic devices for quadriplegia. Chapin, JK.[2019]

Neural prostheses are effective technologies that use electrical stimulation to restore function in individuals with neurological or sensory impairments, specifically focusing on treating neurogenic bladder dysfunction.

The article highlights two clinically available implantable neural prostheses for bladder control, particularly emphasizing their application in children, and discusses three promising developments that could enhance future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprostheses to treat neurogenic bladder dysfunction: current status and future perspectives. Rijkhoff, NJ.[2022]

Neural prosthetics, like cochlear implants developed since 1957, are effective medical devices that interact directly with the nervous system to restore lost functions, making them a clinically accepted form of treatment.

While some neural prosthetic devices, such as cochlear implants, are well-established and widely used, many other technologies are still in experimental stages and require further development to reach their full potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public understanding of neural prosthetics in Germany: ethical, social, and cultural challenges. Laryionava, K., Gross, D.[2015]

The study found an incidence rate of 13.9 nerve injuries and 5.21 traumatic amputations per 100,000 person-years in Sweden from 1998 to 2006, with most injuries occurring at the wrist and hand, often requiring less than a week of hospitalization.

Brachial plexus injuries were identified as the most significant in terms of care consumption, averaging 68 injuries and 960 hospital days annually, indicating a critical area for the development of new neural engineering and neuroprosthetic technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of traumatic peripheral nerve injuries and amputations in Sweden between 1998 and 2006. Asplund, M., Nilsson, M., Jacobsson, A., et al.[2022]

A pilot study demonstrated that a neuroprosthetic hand using deep learning-based control achieved high accuracy (95%-99%) and low latency (50-120 ms) for individual finger movements, showcasing its effectiveness in real-world environments.

The system, implemented on the NVIDIA Jetson Nano, represents a significant advancement in making neuroprosthetic devices portable and autonomous, paving the way for the integration of artificial intelligence in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable, self-contained neuroprosthetic hand with deep learning-based finger control. Nguyen, AT., Drealan, MW., Khue Luu, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03432325

Neural Enabled Prosthesis for Upper Limb Amputees The purpose of this study is to evaluate a new prosthetic system for transradial amputees called the neural-enabled prosthetic hand (ANS-NEPH).

2. ans.uark.edu ans.uark.edu/studies/neural-enabled-prosthesis-upper-limb-amputees.php

Neural Enabled Prosthesis for Upper Limb Amputees The purpose of this study is to evaluate a new investigational prosthetic system called the neural-enabled prosthetic hand (ANS-NEPH).

3. withpower.com withpower.com/trial/phase-11-2017-cdf0d

Neural Enabled Prosthesis for Upper Limb Amputation The Neural Enabled Prosthesis treatment is unique because it uses advanced bioelectronics and deep learning to directly connect with the nervous system, ...

4. nature.com nature.com/articles/s41598-025-15652-y

The socio-economic impact of robotic prosthetics This study evaluates the economic and social impact of a robotics research project culminating in the development of Hannes, an advanced ...

5. edhub.ama-assn.org edhub.ama-assn.org/vha-education/module/2825579

Neural-Enabled Prostheses for Sensory Restoration Insert Over the last decade, advances in myoelectric prostheses have provided individuals with upper-limb amputation with improved capabilities for ...

6. reporter.nih.gov reporter.nih.gov/project-details/9746792

RePORT RePORTER - National Institutes of Health (NIH) | The results of these aims will provide critical safety and efficacy data, and strongly motivate a larger, perhaps pivotal clinical trial across multiple years, ...

7. reporter.nih.gov reporter.nih.gov/search/6YIjNrnHpUSp98rOwfX1ZA/project-details/10451527

RePORT RePORTER - National Institutes of Health (NIH) | Most recently, we have replicated these results in 3 humans with upper limb amputation, routinely recording signals above 100 μV that correspond to individual ...