Actively Recruiting
Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation
Led by Boninger, Michael, MD · Updated on 2026-02-27
5
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
B
Boninger, Michael, MD
Lead Sponsor
R
Ripple Therapeutics Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transradial amputation or wrist disarticulation
- Independent voluntary control of muscles in the forearm flexor and extensor compartments
- At least 1 year post-amputation at time of implantation
- Age between 22 and 70 years
- Ability to communicate in English
- Understanding of study goals and ability to follow simple directions
- Passing neuropsychological and psychosocial assessments
- Provided informed consent
You will not qualify if you...
- Unable to function without a prosthesis or assistance for 6 weeks after implantation and explantation surgeries
- Visual impairment that makes extended computer monitor viewing difficult even with corrective lenses
- Serious diseases or disorders that increase surgical risk
- Severe self-reported phantom limb pain
- Presence of implantable generators such as pacemakers, spinal cord stimulators, cochlear implants, deep brain stimulators, vagus nerve stimulators, or defibrillators
- Pregnancy, lactation, or plans to become pregnant in next 25 months for females of childbearing age
- History of peripheral vascular disease affecting wound healing
- Requirement for routine MRI, therapeutic ultrasound, or diathermy
- Osteomyelitis
- History of clinically relevant cardiac arrhythmias
- Active infections or unexplained fevers
- Untreated alcoholism
- Chronic steroid or immunosuppressive therapy
- Use of medications affecting blood coagulation
- Active cancer within past year (except treated skin cancers) or need for chemotherapy
- Uncontrolled insulin-dependent diabetes mellitus
- Seizure in last two years
- Suicide attempt in past 12 months
- Immunosuppressive conditions or diseases
- Active psychiatric disorders not effectively treated
- Use of controlled non-prescribed substances other than cannabis/marijuana
- Positive drug test for non-prescribed substances other than cannabis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Sydney Bader, MS
CONTACT
D
Debbie Harrington, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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