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

Trial Summary

What is the purpose of this trial?

The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.

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 data supports the effectiveness of the treatment iSens, iSense optical scanner, and Implantable Myoelectric Sensors (IMES) for arm amputees?

Research shows that implantable myoelectric sensors can help amputees control prosthetic limbs more naturally by detecting muscle signals directly, allowing for better movement control. Additionally, studies indicate that providing feedback to the brain about limb movement can improve control of prosthetic hands, suggesting that these technologies can enhance the effectiveness of bionic arms. ^{1 2 3 4 5}

Is the thought-controlled bionic arm safe for human use?

There is interest in implantable interfaces for prostheses, but long-term risks are a concern. Durability, comfort, and improved functional abilities are important factors for users. ^{6 7 8 9 10}

How is the iSens treatment different from other treatments for arm amputees?

The iSens treatment is unique because it uses implantable sensors placed directly in the muscles to control a bionic arm, allowing for more intuitive and simultaneous control of multiple movements compared to traditional surface-based systems that often control movements sequentially. ^{2 11 12 13 14}

Research Team

Dustin J. Tyler, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

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.

Inability to speak English

Timeline

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

Treatment Details

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.

Participant Groups

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Defense Advanced Research Projects Agency

Collaborator

Trials

19

Recruited

78,900+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

A preliminary functional brain study on amputees. [2022]

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

Development of an implantable myoelectric sensor for advanced prosthesis control. [2021]

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

The current state of bionic limbs from the surgeon's viewpoint. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Illusory movement perception improves motor control for prosthetic hands. [2020]

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

The Ewing Amputation: The First Human Implementation of the Agonist-Antagonist Myoneural Interface. [2023]

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

A fully implanted intramuscular bipolar myoelectric signal recording electrode. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Reality of Myoelectric Prostheses: Understanding What Makes These Devices Difficult for Some Users to Control. [2020]

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

Patient perspectives on benefits and risks of implantable interfaces for upper limb prostheses: a national survey. [2022]

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

A third arm - Design of a bypass prosthesis enabling incorporation. [2018]

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

Compensating for delays in brain-machine interfaces by decoding intended future movement. [2020]

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

Technical Details of the Implantable Myoelectric Sensor (IMES) System for Multifunction Prosthesis Control. [2021]

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

Upper extremity myoelectric prosthetics. [2005]

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

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