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โ† Trials
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Peripheral Interfaces in Amputees for Sensorimotor Integration

RecruitingNAAges 21 Years - anyAllVA Office of Research and Development
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • iSens
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Where

2 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, United States
Case Western Reserve University
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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