Evaluation of an Implantable Intramuscular Device to Control a Myoelectric Prosthesis
Boninger, Michael, MD
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.
Description
A well-documented challenge with current myoelectric devices is the common use of only two surface EMG electrodes to record control signals, typically one on each of the extensor and flexor muscle compartments in the residual limb. With this electrode configuration, just a single motion can be controlled at any given time. Changing to new motions or grasp patterns typically requires a secondary switching method. This sequential control enables pre-programmed functional grasps, and can be selected by patterns of co-contraction of antagonist muscle groups. However, this approach has limited succ…
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects must have a unilateral transradial amputation or wrist disarticulation. 2. Subjects must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm 3. Subjects must be over 1-year post-amputation at time of implantation. 4. 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. 5. Subjects must be able to communicate with the investigators in English because of the need to follow the i…
Interventions
- DeviceMyoelectric 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.
Location
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania