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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Boninger, Michael, MD
Study ID
NCT05768802
Status
Recruiting
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Conditions

  • Amputation
  • Amputation; Traumatic, Hand

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Myoelectric Implantable Recording Array (MIRA) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: MIRA Device
    All participants enrolled in the study and who meet eligibility criteria will be implanted with the MIRA device in their residual limb. There is no control group.

Primary Outcome Measure

Number of Participants Explanted [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Sydney Bader, MS
[email protected]
412-648-4196
Debbie Harrington, BS
[email protected]
412-383-1355

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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