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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Neural Enabled Prosthesis for Upper Limb Amputation?

Neural prostheses, which use electrical signals to restore function, have shown success in restoring hand movements in people with paralysis and improving control through sensory feedback. These technologies are promising for helping individuals regain movement and independence. ^{1 2 3 4 5}

Is the Neural Enabled Prosthesis for Upper Limb Amputation safe for humans?

Neural prosthetic devices, like the Neural Enabled Prosthesis, have been used in various forms to restore functions such as hand movement and bladder control, and are generally considered safe in humans. However, they are still in development stages and may involve risks due to their invasive nature, as they interact directly with the nervous system. ^{1 4 6 7 8}

How is the Neural Enabled Prosthesis treatment different from other treatments 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, allowing for intuitive control of a prosthetic hand by interpreting the user's motor intentions through implanted microelectrodes. This approach provides a more natural and precise control compared to traditional prosthetics, which often rely on limited mechanical or surface-level signals. ^{1 4 9 10 11}

Research Team

Paul Pasquina, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Ranu Jung, Ph.D.

Principal Investigator

University of Arkansas, Fayetteville

Eligibility Criteria

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).

18 years of age or older

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Bionic limbs: clinical reality and academic promises. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Neural prosthetic devices for quadriplegia. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Neuroprosthetic applications of electrical stimulation. [2008]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A highly integrated bionic hand with neural control and feedback for use in daily life. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Incidence of traumatic peripheral nerve injuries and amputations in Sweden between 1998 and 2006. [2022]

8. England 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A bioelectric neural interface towards intuitive prosthetic control for amputees. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A portable, self-contained neuroprosthetic hand with deep learning-based finger control. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Recent Developments in Prosthesis Sensors, Texture Recognition, and Sensory Stimulation for Upper Limb Prostheses. [2021]