Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorBoninger, Michael, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Myoelectric Implantable Recording Array (MIRA)
DeviceThe 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: MIRA DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Explanted
Safety of the MIRA device will be measured by tracking the number of individuals explanted prior to the end of the study.
Time frame
12 monthsSecondary outcomes
1
Adverse Events
The type and frequency of device-related adverse events will be recorded by exams and check ins with participants during the study.
Time frame
12 months2
Peak-to-Peak Voltage
Peak-to-peak voltage will be measured over the study duration as a metric of signal quality.
Time frame
12 months3
Signal-to-Noise Ratio
Signal-to-noise ratio will be measured over the study duration as a metric of signal quality.
Time frame
12 months4
Device Control
Participants will be asked to make specific movements, which will be compared to target movements, in order to determine the ability to control different degrees of freedom. Performance will be measured over the duration of the study.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boninger, Michael, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
Ripple Therapeutics Corporation
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov