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 range22 Years – 70 Years
SexALL
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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.
✓. Subjects must pass a neuropsychological and psychosocial assessment.
✓. Documentation of informed consent must be obtained from the subject.
. 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.