Fast Electrode for Hand Amputation

Overseen By Debby Noble

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Nerve dysfunction, Cardiac arrhythmia, others

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

Compensation: Varies

Number of Visits: 12

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called FAST electrodes for individuals with hand, forearm, or arm amputations. The researchers aim to determine if these electrodes can record and stimulate nerve signals that control finger movements and create sensations of touch. The trial is open to individuals whose overall and phantom pain is manageable and who can speak English without an interpreter. Participants will have the electrodes temporarily implanted for about 18 months, during which their nerve signals will be monitored and tested. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance prosthetic technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these FAST electrodes are safe for human amputees?

Research shows that the DEFT system, which uses new FAST electrodes, holds promise for controlling prosthetic limbs. Previous studies found that these electrodes can be safely placed in the body and are generally well-accepted by people. Early results suggest that the electrodes do not cause major side effects when used to control prosthetic hands. Although researchers are still gathering information on long-term safety, current evidence suggests this technology is generally safe. Participants in earlier studies did not report major safety issues, which is encouraging for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional prosthetics and nerve reattachment surgeries, Fast electrodes offer a cutting-edge approach for hand amputation by directly interacting with the nerve signals that control finger movements and sensations. This technology allows for the temporary implantation of electrodes that can both record and play back nerve signals, potentially restoring a more natural sense of touch and movement. Researchers are excited about this treatment because it could lead to more precise and intuitive control of prosthetic hands, significantly enhancing the quality of life for amputees.

What evidence suggests that the Fast electrodes are effective for hand amputation?

Studies have shown that FAST electrodes, tested in this trial, help people control prosthetic hands more effectively. These electrodes connect to specific nerves, enabling real-time control of the prosthetic hand. This allows users to move the prosthetic fingers naturally. Research also suggests that these electrodes can help the hand feel sensations like touch and movement. Previous patients demonstrated improved ability to use their prosthetic hands, making everyday tasks easier. ^{2 3 6 7 8}

Who Is on the Research Team?

Jonathan Cheng, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who have had a hand, forearm, or arm amputation and can manage their pain well. Participants must be able to sign consent, take part in all study activities including device implantation and removal, and communicate effectively in English without an interpreter.

Inclusion Criteria

I am an adult with an amputation of my hand, forearm, or arm.

Able and willing to sign Consent

Able to communicate effectively in English without an interpreter

Exclusion Criteria

My tests show nerve or muscle issues not matching my amputation stump's look.

I have a history of irregular heartbeats.

Radiographs confirm unsuitability of the amputation stump configuration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Pre-operative imaging and diagnostic studies including MRI, x-ray, EMG/Nerve conduction studies, and psychological assessment

Up to 30 days before surgery

Implantation Surgery

Surgery to implant FAST electrodes in the ulnar and median nerves, followed by immediate post-operative care

1 week

Hospital stay up to 2 nights

Post-operative Care

Weekly outpatient care for 3 weeks following implantation surgery, including inspection and dressing changes of electrode leads

3 weeks

Weekly visits (in-person)

Experimental Data Collection

Human physiology experiments including motor and sensory assessments, conducted up to 6 times per month

540 +/- 30 days

Up to 6 visits per month

Explantation Surgery

Surgery to remove implanted electrodes, followed by post-operative care

1 week

1 visit (in-person) post-surgery

Follow-up

Participants are monitored for safety and effectiveness after explantation

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• DEFT

Trial Overview The DEFT trial is testing 'FAST electrodes' implanted for about 540 days in the nerves of people with different levels of limb amputation. The goal is to improve control over prosthetic hands through advanced nerve targeting.

How Is the Trial Designed?

Group I: Fast electrodes Experimental Treatment 1 Intervention

Implant temporary Fast electrodes and record the nerve signals that control delicate finger motions and play back the nerve signals that give the hand feelings of touch and movement.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Defense Advanced Research Projects Agency

Collaborator

Trials

19

Recruited

78,900+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Nerves Incorporated, Inc.

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The new soft neuroprosthetic hand is lightweight (292 g) and low-cost, providing myoelectric control and tactile feedback, which is a significant improvement over traditional heavy and expensive prosthetics.

In tests with individuals who have transradial amputations, this neuroprosthetic hand demonstrated better speed and dexterity compared to conventional rigid designs, allowing one user to regain a sense of touch and control in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A soft neuroprosthetic hand providing simultaneous myoelectric control and tactile feedback. Gu, G., Zhang, N., Xu, H., et al.[2023]

Transplanting a toe to the forearm amputation stump allows for direct control of a specially designed multidimensional electronic prosthetic hand, significantly improving functionality.

After rehabilitation, the prosthetic hand achieved a 100% correct recognition rate when controlled by the transplanted toe, demonstrating a highly effective method for restoring hand function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A reconstructed digit by transplantation of a second toe for control of an electromechanical prosthetic hand. Chen, ZW., Hu, TP.[2022]

The FAST-LIFE approach, which uses multichannel longitudinal intrafascicular electrodes, allows for precise targeting of sensory and motor fascicles in amputated limbs, enabling better control of robotic hands and restoration of sensory feedback.

In clinical studies involving 6 human amputees, this method demonstrated the ability to discern motor intent for individual finger movements, highlighting its potential for improving prosthetic functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fascicle-Specific Targeting of Longitudinal Intrafascicular Electrodes for Motor and Sensory Restoration in Upper-Limb Amputees. Cheng, J., Yang, Z., Overstreet, CK., et al.[2021]

Developing better control interfaces for electric-powered prostheses, such as using cineplasties to connect muscles to prosthetic components, can significantly enhance user control and sensory feedback.

Tracking studies showed that individuals with biceps muscle tunnel cineplasties had improved control capabilities, demonstrating the efficacy of this approach compared to traditional control methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cineplasty as a control input for externally powered prosthetic components. Weir, RF., Heckathorne, CW., Childress, DS.[2006]

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]

Partial hand amputations are common, with an incidence of about 1 in 18,000 people in western countries, yet treatment options have not significantly advanced due to challenges like anatomical variability and the complexity of restoring motor and sensory functions.

Current solutions for partial hand amputations often depend on skilled technicians for fitting rather than modern engineering techniques, highlighting a need for innovative approaches to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of the Partial Hand Amputation: An Engineering Perspective. Imbinto, I., Peccia, C., Controzzi, M., et al.[2022]

The Revolutionizing Prosthetics program, initiated by the Defense Advanced Research Projects Agency in 2006, has led to significant advancements in upper extremity prosthetics, including the potential for direct brain-wave control of prosthetic limbs with 22 degrees of freedom.

Recent innovations, such as individually powered digits, have improved the functionality of prosthetic hands, but restoring sensory feedback remains a critical challenge for enhancing user integration and self-image.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in upper extremity prosthetics. Zlotolow, DA., Kozin, SH.[2022]

A novel electrode design, called the transverse intrafascicular multichannel nerve electrode (TIME), shows promise in selectively activating small nerve fibers, which could help alleviate phantom limb pain (PLP) in amputees.

Preliminary studies in small and large animal models demonstrated good biocompatibility and stability of the implant, paving the way for future human clinical trials to explore its effectiveness in treating PLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a neurotechnological system for relieving phantom limb pain using transverse intrafascicular electrodes (TIME). Stieglitz, T., Boretius, T., Navarro, X., et al.[2013]

This case study introduces a novel targeted sensory reinnervation technique that successfully restored sensory function in a transhumeral amputee by rerouting specific nerve fascicles to cutaneous nerves, allowing for distinct hand maps of sensation.

The subject was able to control a robotic arm while receiving touch and force feedback, demonstrating the first successful dual flow of motor and sensory information in a prosthetic limb, which is a significant step towards creating more natural and functional prosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel targeted sensory reinnervation technique to restore functional hand sensation after transhumeral amputation. Hebert, JS., Olson, JL., Morhart, MJ., et al.[2014]

Longitudinally implanted intrafascicular electrodes (LIFEs) demonstrated excellent biocompatibility in a rabbit sciatic nerve model, showing stable signal recording capabilities over a six-month period with only mild tissue damage observed.

In a human test, LIFEs successfully recorded distinct signals from the radial, ulnar, and median nerves during voluntary hand movements, which could be utilized to control an electronic prosthetic hand, indicating their potential for advanced prosthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimental study of biocompatibility of LIFEs in peripheral fascicles]. Zheng, XJ., Zhang, J., Chen, ZW., et al.[2006]

Targeted muscle reinnervation (TMR) allows high-level amputees to control myoelectric prostheses more effectively, and using a generically placed electrode grid can enhance performance.

In a study with two transhumeral amputee subjects, the grid electrode layout resulted in faster action completion (0.290 to 1 second quicker) and lower classification error (1.35% vs. 3.2%) compared to traditional localized electrode placements, suggesting improved control and easier fitting for prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of pattern recognition myoelectric control using a generic electrode grid with targeted muscle reinnervation patients. Tkach, DC., Young, AJ., Smith, LH., et al.[2020]

Citations

1. jhandsurg.org jhandsurg.org/article/S0363-5023(17)31029-8/pdf

Dexterous Hand Control Through Fascicular Targeting ( ... This work will catalyze several key areas of research on the dexterous control of prosthetic hands. Methods: FAST surgical targeting of LIFE ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4501393/

Dexterous Control of a Prosthetic Hand Using Fine-Wire ... Here we demonstrate the feasibility of achieving real-time, continuous and simultaneous control of a multi-digit prosthesis directly from forearm muscles ...

3. iopscience.iop.org iopscience.iop.org/article/10.1088/1741-2552/abc3d3

A bioelectric neural interface towards intuitive prosthetic ... Here we present a technology platform combining fully-integrated bioelectronics, implantable intrafascicular microelectrodes and deep learning- ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24760929/

Dexterous control of a prosthetic hand using fine-wire ... Here we demonstrate the feasibility of achieving real-time, continuous and simultaneous control of a multi-digit prosthesis directly from forearm muscles ...

5. researchgate.net researchgate.net/publication/261840083_Dexterous_Control_of_a_Prosthetic_Hand_Using_Fine-Wire_Intramuscular_Electrodes_in_Targeted_Extrinsic_Muscles

Dexterous Control of a Prosthetic Hand Using Fine-Wire ... The use of implanted intramuscular EMG electrodes can address some of the challenges associated with using surface EMG for pattern recognition.

6. ieeexplore.ieee.org ieeexplore.ieee.org/ielaam/10/9895313/9738457-aam.pdf

Artificial Intelligence Enables Real-Time and Intuitive Control of ... , “Dexterous Hand Control Through Fascicular Targeting. (HAPTIX-DEFT): Level 4 Evidence,” Journal of Hand Surgery, vol. 42, no. 9, pp. S8-S9, 2017. [40] ...

7. researchgate.net researchgate.net/publication/359278016_Artificial_Intelligence_Enables_Real-Time_and_Intuitive_Control_of_Prostheses_via_Nerve_Interface

(PDF) Artificial Intelligence Enables Real-Time and Intuitive ... Results: First, we show the AI agent enables amputees to intuitively control a prosthetic hand with individual finger and wrist movements up to 97-98% accuracy.

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Amputation%3B%20Traumatic%2C%20Hand%22

San Mateo Clinical Trials The purpose of this study is to improve prosthesis control for transradial amputees with combining targeted muscle reinnervation surgery (TMR) and pattern ...