Who is eligible for clinical trial NCT05768802?

Participants must meet the protocol's inclusion criteria for Amputation. The stated age range is 22 Years to 70 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05768802 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-25

Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation (NCT05768802)

Evaluation of an Implantable Intramuscular Device to Control a Myoelectric Prosthesis

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Boninger, Michael, MD

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (22 items).

Location: University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania

Age range: 22 Years to 70 Years

🧪 Interventions in This Study

Myoelectric Implantable Recording Array (MIRA) (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Subjects must have a unilateral transradial amputation or wrist disarticulation.
Subjects must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm
Subjects must be over 1-year post-amputation at time of implantation.
Subjects must be between the ages of 22 and 70 years old. Subjects outside this age range may be at an increased surgical risk and increased risk of fatigue during prosthetic training.
Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.
Subjects must pass a neuropsychological and psychosocial assessment.
Documentation of informed consent must be obtained from the subject.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Subjects must be able to function without the use of a prosthesis, or have access to assistance, for a period of 6 weeks following implantation and explantation surgeries.
Subjects must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses.
Subjects who have another serious disease(s) or disorder(s) that could affect their ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status) will be excluded.
Subjects must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain).
Subjects must not have any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS) or DBS leads, vagus nerve stimulator, or defibrillator.
Female subjects of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months.
Subjects must have no history of peripheral vascular disease that could impact wound healing.
Subjects who require routine MRI, therapeutic ultrasound, or diathermy as part of their ongoing care will be excluded.
Subjects must not have osteomyelitis.
Subjects must have no history of intractable clinically relevant cardiac arrhythmias.
Subjects must have no active infection(s) or unexplained fever(s) (verified during pre-op anesthesia evaluation to determine surgical risk status).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania

📞 Contact the Study Coordinator

Phone: (412) 648-4196

Email: syb17@pitt.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Amputation

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Powered Prosthesis for Use With TF Osseointegration Recipients — Chicago, Illinois
Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation — Austin, Texas
Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients — Bethesda, Maryland
Development and Usability of an Adjustable Prosthesis for Aquatic Therapy — Chicago, Illinois

Explore by condition: All Amputation clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗