Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation — MIRA  

Amputation Clinical Trial

Official title: Evaluation of an Implantable Intramuscular Device to Control a Myoelectric Prosthesis

Status Recruiting

Clinical Trial Summary

The purpose of this research study is to see how well a new type of myoelectric prosthesis works. A myoelectric prosthesis is a robotic limb for amputees that is controlled by sensing the activity of muscles in the body above the amputation level. This study involves a medical procedure to implant the Myoelectric Implantable Recording Array (MIRA) in the residual limb. The procedure will be performed under sedation by a physician. When muscles contract, they generate an electrical signal that can be sensed by MIRA and used to control the prosthetic limb. Myoelectric prosthetic limbs normally use electrodes that are placed on the surface of the skin to control different movements. However, MIRA is implanted under the skin, which could improve the ability to control the myoelectric prosthesis. After the MIRA is implanted, training will occur to learn how to control the prosthesis using the muscles in the residual limb. The device can stay implanted for up to one year. The device will be removed (explanted) by a physician.

Clinical Trial Description

A well-documented challenge with current myoelectric devices is the common use of only two surface EMG electrodes to record control signals, typically one on each of the extensor and flexor muscle compartments in the residual limb. With this electrode configuration, just a single motion can be controlled at any given time. Changing to new motions or grasp patterns typically requires a secondary switching method. This sequential control enables pre-programmed functional grasps, and can be selected by patterns of co-contraction of antagonist muscle groups. However, this approach has limited success due to the slow and non-intuitive nature of the required muscular activations. For example, contraction of flexor muscles may be used to close the hand, but in order to rotate the wrist, a co-contraction of the flexors and extensors (to switch control modes) followed by flexor contraction is required. This non-intuitive approach ignores the normal function of forearm muscles and has a further disadvantage that simultaneous control of hand aperture and wrist rotation is impossible. Adding additional grasping patterns can make the problem worse and often requires the user to step through the different pre-programmed patterns by making multiple co-contractions until the correct movement is selected. Surface electrode-based systems also rely on strong muscle contractions, which are inefficient and contribute to awkward usability and ultimate rejection of the prosthesis. Other complications that are associated with surface electrodes are signal changes due to environmental conditions such as sweating, daily changing of electrode locations due to skin-related issues, and susceptibility to crosstalk and movement artifacts. In contrast, implantable electrodes are protected from environmental conditions, remain fixed in place, can record small signals from gently contracting muscles, and can record many different signals to potentially allow for more complex and simultaneous control of multiple joints.

Recent research with myoelectric control has focused on developing new control paradigms, such as simultaneous multi-degree of freedom control and proportional velocity control. Often, surface EMG recordings from an antagonistic pair of muscles are used to control a single degree of freedom. Implantable electrodes have shown promise as an alternative method in preliminary human subject studies, and recent research has demonstrated that up to three degrees-of-freedom have been simultaneously controlled in a virtual environment using intramuscular electrodes, as well as proportional velocity control. The Implantable Myoelectric Sensor (IMES®) System utilizes eight implanted electrodes (six actively needed for control, two as back-ups) to control three degrees-of-freedom. Another study using the same EMG leads and electrode configuration as MIRA, implanted percutaneously, enabled simultaneous control of up to 6 degrees of freedom (thumb flexion, index flexion, middle flexion, thumb adduction and abduction, wrist flexion and extension, and wrist pronation and supination) of an advanced prosthesis. As myoelectric prostheses move away from preprogrammed movements and pattern recognition, a minimum of two electrodes implanted in separate muscle targets appears to be necessary to control a single degree of freedom.

The investigator's approach aims to address the limitations of controlling state-of-the-art prosthetic hands. Multichannel intramuscular EMG recordings using the MIRA implant will be used to drive simultaneous hand and wrist movements providing a significant improvement in motor control over the current state-of-the-art. More specifically, the goal is to achieve control of wrist rotation and open/close of the hand and optimally, flexion/extension of the wrist and independent flexion/extension of four fingers. People with transradial amputations will be recruited into this study with the goal of restoring hand and wrist function.

The investigators have designed MIRA to eliminate percutaneous connections, which will reduce the risk of infection and minimize the amount of care required by study subjects. The study is designed to last for one year including a significant amount of in-home testing. Telerehabilitation principles (e.g. remote monitoring, regular progress checks) will be used to ensure frequent communication with investigators and regular assessment of device performance. Conducting a year-long study will provide sufficient time to allow for subjects to learn to use their new device and also allow us to document long-term device performance. The investigators will collect preliminary safety data and document the type and frequency of any adverse events that occur for the duration of the implantation. EMG signal quality and overall device performance over the duration of the implantation will also be measured. ;

Related Conditions & MeSH terms

• Amputation
• Amputation, Traumatic
• Amputation; Traumatic, Hand

• NCT number: NCT05768802
• Study type: Interventional
• Source: University of Pittsburgh
• Contact: Sydney Bader, MS
• Phone: 412-648-4196
• Email: syb17@pitt.edu
• Status: Recruiting
• Phase: N/A
• Start date: October 2024
• Completion date: December 2029