Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how to help people with upper limb amputations feel sensations in their missing hand using special technology. The researchers want to understand how to use small electric currents to stimulate the nerves in the residual limb (the part of the arm that remains after amputation). By doing this, they hope to create better ways for prosthetic hands to move and provide feedback about where the hand is and how it is moving, just like a natural hand would.

If someone is interested in participating, they should be between the ages of 65 and 74 and have had an upper limb amputation, either above or below the elbow, with a fully healed surgical site. They should also be using a prosthesis and able to follow study instructions. Participants will undergo nerve stimulation and will provide feedback on their sensations, helping researchers improve prosthetic technology. It’s important for potential participants to be mentally and physically fit for the study, and they will need to be willing to follow all study procedures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites
• • Viable peripheral nerve function in the residual nerves serving the limb
• • Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb
• • Medically fit to undergo general anesthesia
• • Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis
• • Willingness and availability to follow the study protocol
• • Willingness to undergo psychological evaluation, if recommended by study surgeons or investigators, to determine that the participant is mentally competent and capable of completing the study-related activities
• Exclusion Criteria:
• • Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand amputation
• • Inability to speak English
• • Medically unfit to undergo surgery
• • Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial
• • Uncontrolled diabetes (HgbA1c\>8.0%)
• • History of neuropathy and/or radiculopathy in the target limb
• • Active infection or open sores on the residual limb
• • History of frequent infection or sores with unknown cause
• • Inability to provide informed consent or follow experimental protocols
• • Severe pain that would prevent the participant from completing study-related activities
• • Poor surgical candidate