Thought-Controlled Bionic Arm for Arm Amputees

(iSens Trial)

Overseen By Melissa S Schmitt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Uncontrolled diabetes, Active infection, Autoimmune diseases, 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: 3 months

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bionic arm called iSens, designed for thought control and sensory feedback. The aim is to assess the safety and effectiveness of this advanced prosthetic for individuals who have lost an arm. Participants will either use their current prosthesis or try the iSens system for three months. The trial seeks individuals who have had an upper limb amputation for at least six months and currently use or are prescribed a myoelectric prosthesis. As an unphased trial, it offers participants the chance to be at the forefront of innovative prosthetic technology.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you use any active medical devices that are necessary for your health, you may not be eligible to participate.

What prior data suggests that the iSens device is safe for arm amputees?

Research shows that the iSens system, which uses tiny sensors placed in muscles to detect signals, is under study for safety and effectiveness. In earlier studies, these sensors showed promise in helping control prosthetic arms for individuals who have lost an arm. Importantly, the sensors do not require wires to be threaded through the arm or to break the skin, reducing the risk of infection and other complications.

In a small trial, these sensors successfully recorded and transmitted muscle signals without wires. The study reported no serious safety problems, suggesting that the treatment is well-tolerated. While testing of this system continues, the absence of major issues in earlier studies provides reassurance about its safety for future participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iSens system is unique because it allows arm amputees to control a bionic arm using thought, which is a groundbreaking departure from standard prosthetics that rely on muscle movement or mechanical components. This thought-controlled mechanism offers a more natural and intuitive way for users to operate their prosthetic limbs, potentially improving functionality and user satisfaction. Researchers are excited because this approach could significantly enhance the quality of life for amputees by providing a prosthetic solution that closely mimics the natural movement and control of a real arm.

What evidence suggests that the iSens device is effective for arm amputees?

Research has shown that implantable myoelectric sensors (IMES), part of the iSens system tested in this trial, help amputees control prosthetic limbs more naturally. These sensors detect muscle signals directly, enabling users to move the prosthetic arm by simply thinking about the motion. Studies indicate that this technology makes prosthetic use easier and more precise. The iSens system combines these sensors with advanced technology to create an intuitive prosthetic experience. This approach is promising because it aims to make the prosthetic feel more like a natural part of the body. Participants in this trial will either use the iSens system or continue with their own state-of-the-art prosthesis for comparison. ^{1 2 6 7 8}

Who Is on the Research Team?

Dustin J. Tyler, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for adults over 21 who have had an upper limb amputation at least 6 months ago and are using or prescribed a myoelectric prosthesis. They must be mentally fit to participate, as confirmed by a psychologist, and have healthy nerves in the affected limb. People with poor wound healing, infections, pregnancy, inability to speak English, arthritis near the implant area or those needing MRI scans can't join.

Inclusion Criteria

I am 21 years old or older.

A psychologist has confirmed I'm mentally fit for the study.

It has been over 6 months since my amputation.

Exclusion Criteria

I have arthritis near where my implant is located.

I have long-lasting open sores on my skin.

My diabetes is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Surgical implant of cuff electrodes on residual nerves and muscle recording electrodes in muscles, connected to an implanted stimulator

1 week

Treatment

Participants use the iSens system or their own prosthesis for 3 months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

What Are the Treatments Tested in This Trial?

Interventions

• iSens

Trial Overview

The study tests 'iSens', an implanted wireless device that aims to enhance control of prosthetic limbs through improved sensory feedback. It's designed for people with arm amputations to see if it's safe and effective compared to current prosthetic devices.

How Is the Trial Designed?

Group I: iSens Experimental Treatment 1 Intervention

3 months trial with the iSens system

Group II: State of the Art Prosthesis Active Control 1 Intervention

3 months trial with their own prosthesis.

iSens is already approved in United States for the following indications:

Approved in United States as iSense optical scanner for:

• Residual limb volume measurement

Approved in United States as Implantable Myoelectric Sensors (IMES) for:

• Control of externally powered prosthetics

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Defense Advanced Research Projects Agency

Collaborator

Trials

19

Recruited

78,900+

Published Research Related to This Trial

The development of a multichannel prosthetic hand/arm controller system aims to enhance control by utilizing signals from up to sixteen implanted EMG electrodes, which can significantly improve user interaction with the prosthesis.

The system uses a transcutaneous magnetic link for both power supply and data transmission, allowing for efficient communication of user intent from the implanted electrodes to the external prosthesis controller.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Details of the Implantable Myoelectric Sensor (IMES) System for Multifunction Prosthesis Control. Weir, R., Troyk, P., Demichele, G., et al.[2021]

Myoelectric control has been an effective method for controlling upper limb prostheses for over 30 years, demonstrating reliability and durability in various situations.

The future of prosthetic technology lies in integrating multiple control schemes and utilizing advancements like microprocessors to enhance functionality, aiming to better replicate the natural movement and appearance of the human arm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity myoelectric prosthetics. Uellendahl, JE.[2005]

The development of an implantable myoelectric sensor allows for more precise control of prosthetic hands and wrists by detecting muscle signals directly at the source, potentially enabling independent control of multiple movements.

In initial tests, a subject was able to intuitively and simultaneously control two degrees of freedom in a prosthetic hand, demonstrating the system's effectiveness and paving the way for future human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an implantable myoelectric sensor for advanced prosthesis control. Merrill, DR., Lockhart, J., Troyk, PR., et al.[2021]

Bionic limbs provide a crucial interface between biological tissue and electronic devices, enhancing motor control and sensory feedback for amputees, which can lead to better reintegration into society and improved embodiment of the prosthetic limb.

There are three main types of bionic limb interfacing: targeted muscular reinnervation (TMR), direct muscle interfacing, and direct nerve interfacing, each offering unique advantages such as improved sensation and controllability, while the surgical implantation process aims to minimize nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of bionic limbs from the surgeon's viewpoint. Bumbaširević, M., Lesic, A., Palibrk, T., et al.[2020]

Cortical reorganization in the brain allows for interaction between the motor cortex and remnant muscles of amputees, suggesting that myoelectric prostheses can restore hand capabilities even years after amputation.

Recent advancements in myoelectric hand prostheses, particularly those using pattern recognition for natural movement control, show promise for improving the functionality and usability of prosthetics, although many systems still require extensive training to use effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control Capabilities of Myoelectric Robotic Prostheses by Hand Amputees: A Scientific Research and Market Overview. Atzori, M., Müller, H.[2020]

The agonist-antagonist myoneural interface (AMI) was successfully implemented in 3 human subjects after below-knee amputation, showing promising results in controlling and interpreting proprioception from a bionic ankle.

All subjects experienced minor complications but reported a high degree of phantom limb position perception without phantom pain, suggesting that AMIs could enhance prosthetic control and sensory feedback for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ewing Amputation: The First Human Implementation of the Agonist-Antagonist Myoneural Interface. Clites, TR., Herr, HM., Srinivasan, SS., et al.[2023]

A new fully implanted bipolar intramuscular myoelectric signal (IM-MES) recording electrode was successfully developed, allowing for effective functional electrical stimulation (FES) and prosthetic control.

In vivo testing showed that the IM-MES electrode recorded myoelectric signals comparable to existing electrodes, and initial clinical applications demonstrated its effectiveness in providing command signals for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fully implanted intramuscular bipolar myoelectric signal recording electrode. Memberg, WD., Stage, TG., Kirsch, RF.[2023]

Myoelectrically controlled prosthetic arms significantly enhance the functionality and quality of life for upper-extremity amputees by using muscular signals from the residual limb to control the device.

Recent advancements in the Myobock system and fitting procedures have improved the reliability of the connection between the user and the prosthetic, indicating a positive trend in the development of adaptive prosthetic technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The artificial substitution of missing hands with myoelectrical prostheses. Näder, M.[2005]

Myoelectric prostheses are often difficult for users to control, leading to passive use or rejection, which can negatively affect the user's other limb due to overuse.

A new protocol is being developed to assess user skill in generating EMG signals and the predictability of prosthesis response, aiming to identify key factors that influence functionality and everyday usage of prostheses, which could guide future improvements in design and clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reality of Myoelectric Prostheses: Understanding What Makes These Devices Difficult for Some Users to Control. Chadwell, A., Kenney, L., Thies, S., et al.[2020]

A significant portion of Veterans (41.8% of unilateral and 40.6% of bilateral amputees) expressed willingness to consider surgery for implantable interfaces that restore touch, while 49.0% were interested in improved movement control, indicating a strong interest in enhancing prosthetic functionality.

Factors influencing willingness included age and mental health, with younger individuals (18-45) being more likely to consider surgery, and myoelectric users showing greater interest in control compared to body-powered users. Long-term risks were viewed as the most unacceptable, while durability and comfort were prioritized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives on benefits and risks of implantable interfaces for upper limb prostheses: a national survey. Resnik, L., Benz, H., Borgia, M., et al.[2022]

A new method using vibrating muscles in amputees allows them to gain a kinesthetic sense of control over robotic hands, enhancing their ability to perform complex grip movements.

In a study with three amputees, this feedback system improved their movement control within minutes, demonstrating the potential for better integration of prosthetics with human intention and perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illusory movement perception improves motor control for prosthetic hands. Marasco, PD., Hebert, JS., Sensinger, JW., et al.[2020]

Decoding intended future movements (up to 200 ms ahead) rather than current movements can significantly reduce lag in brain-machine interface (BMI) control of prosthetic arms, improving performance.

Testing on a monkey demonstrated that performance improved with longer prediction times, achieving optimal results when the prediction time matched the system's inherent delay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensating for delays in brain-machine interfaces by decoding intended future movement. Willett, FR., Suminski, AJ., Fagg, AH., et al.[2020]

A novel bypass prosthesis has been developed to allow able-bodied subjects to effectively use a myoelectric prosthetic hand, designed to feel like a natural extension of their own limb, which is crucial for accurate research on prosthesis incorporation.

The prosthesis features advanced control systems and feedback mechanisms, including electrical stimulation and vibration, to enhance the user's sensory experience and responsiveness, providing preliminary evidence of successful prosthesis incorporation during tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A third arm - Design of a bypass prosthesis enabling incorporation. Wilson, AW., Blustein, DH., Sensinger, JW.[2018]

The study involved 18 participants (9 unilateral amputees and 9 controls) and used advanced techniques like functional MRI to show that brain activation patterns are similar when both groups mentally simulate foot movement, indicating that the brain retains its ability to command movement even after amputation.

These findings suggest that brain activation can potentially be harnessed to control artificial limbs, offering promising implications for rehabilitation strategies for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary functional brain study on amputees. da Paz, AC., Braga, LW., Downs, JH.[2022]

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