RecruitingNot ApplicableNCT05768802

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

Evaluation of an Implantable Intramuscular Device to Control a Myoelectric Prosthesis


Sponsor

Boninger, Michael, MD

Enrollment

5 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

When someone loses a hand or forearm due to amputation, controlling a prosthetic limb intuitively remains one of the biggest challenges in rehabilitation. This study tests an implantable device called MIRA (Myoelectric Implantable Recording Array) that is placed under the skin in the forearm to directly record the electrical signals from muscles — providing much richer and more reliable signals than surface electrodes can — to enable more natural, precise prosthetic hand control. The study is open to adults aged 22 to 70 who have had a single arm amputation below the elbow (or wrist disarticulation) for at least one year, can voluntarily contract muscles in both the front and back of their forearm, can communicate in English, and pass a neuropsychological assessment. A long list of medical conditions, medications, and implanted devices (like pacemakers) that could create safety risks during surgery or interfere with the device are exclusion criteria. Pregnancy, severe phantom limb pain, uncontrolled diabetes, recent cancer, and seizures within the last two years are among the key exclusions. Participants undergo a surgical implantation, complete prosthetic training sessions, and have the device removed at the end of the study. This research is important because it could pave the way for a generation of prosthetic limbs that feel and respond much more like natural hands.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMyoelectric Implantable Recording Array (MIRA)

The Myoelectric Implantable Recording Array (MIRA) will use electromyography to detect the electrical activity of forearm muscles and transmit that information to an externally-powered prosthetic limb. The MIRA is implanted under the skin.


Locations(1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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NCT05768802


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