Peripheral Interfaces in Amputees for Sensorimotor Integration

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new type of prosthetic device designed for people who have lost an arm or part of an arm. The goal is to learn how safe and effective this wireless prosthetic is, which can help users feel more connected to their device and control it more naturally. Researchers are currently looking for participants who are at least 21 years old and have had an upper limb amputation for at least six months. It's important that potential participants are already using or have been prescribed a myoelectric prosthesis, which is a type of prosthetic that is controlled by electrical signals from the muscles.

If you join the study, you can expect to undergo a few assessments to ensure you're a good fit. Participants will need to have certain nerves in their arm that can be targeted for the device and should be mentally capable of following study instructions, as determined by a psychologist. There are some conditions that might prevent someone from participating, such as uncontrolled diabetes or an active infection. Overall, this trial offers a chance to contribute to important research that could improve prosthetic technology and help others in the future.

Gender

ALL

Eligibility criteria

• 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.