Study Title:
Evaluation of an Implantable Intramuscular Device to Control a Myoelectric Prosthesis
Study Location:
University of Pittsburgh + a participant’s home environment
Research Objectives:
We will investigate using MIRA to detect EMG activity in humans long-term. Five individuals with transradial amputation will be surgically implanted with MIRA for one year. This duration may be extended if use of the device is successful. Study subjects will learn to control a myoelectric prosthesis using muscle activity recorded from electrodes implanted in the muscles of the residual limb. The data collected will support our hypothesis that EMG signals can be recorded and transmitted wirelessly in order to provide control of prosthetic hand and wrist functions.
Eligibility Criteria:
1) Must have a unilateral transradial amputation or wrist disarticulation.
2) Must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm.
3) Must be over 1-year post-amputation
4) Must be between ages of 22 and 70.
5) Must be able to communicate in English
Compensation Details:
Maximum compensation is $6600 for 1 year implant. This includes $50 per visit or per day for screening, pre-operative activities, surgery-related visits, and up to $500 per month for both in-home and in-lab experiments. Travel and lodging will be reimbursed.
Enrollment Closes:
Apr 30, 2030
Time Commitment:
Approximately 8 screening visits in Pittsburgh, lasting 2-4 hours each.
Between 2-7 days for implant surgery and surgery-related procedures,
Up to 6 weeks of rest and recovery following surgery.
Several visits to prosthetist for custom socket fitting.
Two weeks in Pittsburgh for lab-based training.
Once home, weekly virtual visits with research team.
Visits to Pittsburgh lab every 3 months.
Between 2-7 days for explant surgery and surgery-related procedures.
NOTE: Based upon safety and success with the device, and the participant’s choice, the duration of implant may be extended.
Contact Person:
Debbie Harrington, 412-383-1355, debbie.harrington@pitt.edu
How to Participate:
Call Debbie at 412-383-1355.
URL link to website or survey:
https://www.rnel.pitt.edu/clinical-trials/individuals-amputation