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Recruiting NCT04430218

Peripheral Interfaces in Amputees for Sensorimotor Integration

Conditions: Upper Extremity Amputee

Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: VA Office of Research and Development

Location: Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio

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.

Eligibility Criteria

Inclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04430218). StuddyBuddy aggregates publicly available trial information.