Sonomyography-Controlled Prosthetics for Amputees

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Mason University

Disqualifiers: Cognitive, neurological, physical deficits, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to control prosthetic arms using ultrasound imaging (sound waves to see inside the body) instead of the usual electrical signals from muscles. The goal is to make prosthetic arms more useful and easier to control for those who have lost an arm below the elbow. Participants will help researchers compare this new method, known as the Sonomyographic Prosthesis, with the traditional one by using both in virtual settings and real-life tasks. The trial seeks individuals who have lost one arm below the elbow and either haven't used a myoelectric prosthesis for three years or more, or currently use a specific pattern recognition system. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform prosthetic technology.

Do I need to stop my current medications for the trial?

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 this prosthetic control system is safe for amputees?

Research has shown that sonomyography, which uses ultrasound signals to control prosthetic hands, is safe and effective. This method places ultrasound devices on muscles to detect signals. Over the past decade, various studies have explored this technique. So far, research suggests that using ultrasound to control prosthetic hands is safe and well-tolerated. No major reports have directly linked negative effects to sonomyography. While this technology is still developing, early results are promising for those considering this type of prosthetic control. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sonomyographic-controlled prosthetics because they offer a unique way to control prosthetic hands using ultrasound signals from muscle deformation, rather than the traditional myoelectric method, which relies on surface electromyography signals. This new approach could provide more intuitive and precise control, as the ultrasound signals may capture more detailed information about muscle movements. The potential for enhanced dexterity and responsiveness in prosthetic devices is what makes this method stand out and could significantly improve the quality of life for amputees.

What evidence suggests that this trial's prosthetic control methods could be effective for amputees?

In this trial, participants will join different treatment arms to evaluate prosthetic control methods. One arm will use sonomyographic control, which employs ultrasound to detect muscle movement for real-time prosthetic hand control. Previous studies have shown that this technique allows for more precise control compared to older methods, potentially improving functionality and ease of use for individuals who have lost an upper limb. Evidence suggests that sonomyographic control could reduce the high rate of prosthetic abandonment seen with other systems. Early signs indicate a significant improvement in users' ability to perform everyday tasks with these advanced prosthetics. Another arm in this trial will use myoelectric control, which utilizes surface electromyography signals from muscle activation to control a prosthetic hand. ^{1 2 3 6 7}

Who Is on the Research Team?

Siddhartha Sikdar, PhD

Principal Investigator

George Mason University

Are You a Good Fit for This Trial?

This trial is for individuals with a transradial unilateral amputation who speak English. Participants must either be new to myoelectric prostheses or currently use a specific commercial pattern recognition prosthesis. People with significant cognitive, neurological, or physical deficits, uncontrolled pain, or serious medical problems cannot participate.

Inclusion Criteria

Fluent in English

I have not used a myoelectric prosthesis for at least 3 years.

I have had one arm amputated above the wrist.

Exclusion Criteria

My health issues are under control, as confirmed by my doctor.

My pain is not well-managed and affects my daily activities.

My limb loss affects my ability to fully participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation of the subject's functionality using the Orthotics and Prosthetics User Survey Upper Extremity Functional Status (OPUS-UEFS)

1 week

Training and Testing

Participants undergo training and testing with both sonomyography and myoelectric control systems using a two-by-two AB/BA crossover design

4 weeks

Multiple sessions over 4 weeks

Washout Period

A washout period between crossover phases to minimize carryover effects

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Myoelectric direct control prosthesis
• Myoelectric pattern recognition prosthesis
• Sonomyographic Prosthesis

Trial Overview The study tests a new sonomyographic prosthetic control system against two types of myoelectric prostheses: direct control and pattern recognition. The goal is to improve functionality in upper limb prosthetics by using ultrasound imaging to sense muscle activity for more intuitive control.

How Is the Trial Designed?

Group I: Sonomyographic control Experimental Treatment 1 Intervention

Sonomyographic control involves the use of ultrasound signals from muscle deformation to control a prosthetic hand.

Group II: Myoelectric control Active Control 2 Interventions

Myoelectric control involves the use of surface electromyography signals from muscle activation to control a prosthetic hand.

Who Is Running the Clinical Trial?

George Mason University

Lead Sponsor

Trials

60

Recruited

50,200+

Infinite Biomedical Technologies

Industry Sponsor

Trials

7

Recruited

160+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11230649/

Sonomyography for Control of Upper-Limb Prostheses An individual's likelihood of successfully adopting a sonomyographic prosthesis may depend on a variety of clinical factors such as ease of use and reliability, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05376332

Sonomyographic Upper Limb Prosthetics: A New Paradigm Data will be evaluated to determine the distribution and the variability of performance within and between the different prosthesis systems. The investigators ...

3. nature.com nature.com/articles/s41598-019-45459-7

Proprioceptive Sonomyographic Control: A novel method ... Prosthetic non-wear has been reported in 20% of individuals with upper limb loss and rejection rates for upper limb prosthetic users range from ...

4. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.876836/full

First Demonstration of Functional Task Performance Using ... We present the first demonstration of real-time prosthetic hand control using sonomyography to perform functional tasks.

5. journals.lww.com journals.lww.com/jpojournal/fulltext/2024/07000/sonomyography_for_control_of_upper_limb.6.aspx

Sonomyography for Control of Upper-Limb Prostheses Ultrasound-based sensing of muscle deformation, known as sonomyography, is an emerging sensing modality for upper-limb prosthesis control.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9959820/

Controlling Upper Limb Prostheses Using Sonomyography ... The use of ultrasonic technology in sensor implementation for identifying finger motions in prosthetic applications has been researched over the last ten years.

7. mdpi.com mdpi.com/1424-8220/25/13/3968

A Highly Efficient HMI Algorithm for Controlling a Multi- ... Sonomyography (SMG) is a method of controlling upper-limb prostheses through an innovative human–machine interface by monitoring forearm muscle activity ...