Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amp… (NCT05768802) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation
United States5 participantsStarted 2026-01-16
Plain-language 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.
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects must pass a neuropsychological and psychosocial assessment.
. Documentation of informed consent must be obtained from the subject.
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.