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

NCT05768802 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Amputation
  • Amputation; Traumatic, Hand

Interventions

DEVICE

Myoelectric Implantable Recording Array (MIRA)

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.

Sponsors & Collaborators

  • Ripple Therapeutics Corporation

    collaborator INDUSTRY

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Boninger, Michael, MD

    lead OTHER

Principal Investigators

  • Robert Gaunt, PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768802 on ClinicalTrials.gov