Status:
RECRUITING
Peripheral Interfaces in Amputees for Sensorimotor Integration
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
United States Department of Defense
Congressionally Directed Medical Research Programs
Conditions:
Upper Extremity Amputee
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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.
Detailed 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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2032
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04430218
Start Date
August 18 2020
End Date
June 30 2032
Last Update
August 14 2025
Active Locations (1)
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1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702