Overview
The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
Description
The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.
Eligibility
Inclusion Criteria:
- Age 21 or greater
- Acquired upper limb amputation
- Unilateral or bilateral amputation, Above or below elbow
- At least 6 months since time of amputation
- Current user of a myoelectric prosthesis or prescribed to use one
- Viable target nerves in the upper extremity \*
- Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
Exclusion Criteria:
- A contraindication preventing surgery
- Uncontrolled diabetes
- Chronic skin ulcerations
- History of poor wound healing without specific cause
- History of uncontrolled infection without specific cause
- Active infection
- Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
- Inability to speak English
- Expectation that MRI will be required at any point for duration of study or while device is implanted.
- Arthritis in the area of implant
- Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
- Presence of auto immune diseases, or conditions requiring immunosuppression.
