Peripheral Interfaces in Amputees for Sensorimotor Integration
Recruiting now · Not applicable
Conditions studied: Upper Extremity Amputee
In brief
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.
Key facts
- Study ID
- NCT04430218
- Run by
- VA Office of Research and Development
- People needed
- 15
- Starts
- 2020-08-18
- Expected to finish
- 2032-06-30
- Last updated by the study team
- 2026-07-17
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (enrolling)
- Case Western Reserve University — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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