NYU Langone Health
This is a single-center, prospective, within-subject study. This study seeks to enroll a total of 32 prospective subjects who will undergo surgical implantation of the FDA-approved Altius® system. Subjects will be followed longitudinally and will complete a series of patient-reported outcome measure questionnaires, a study intake questionnaire which assesses demographics, amputation and prosthesis history, and medical/medication history.
Inclusion Criteria: * Adults (≥18 years old) * Lower extremity amputees with prior TMR, RPNI at least 9 months prior to enrollment, or similar nerve-targeted surgery who have persistent neuropathic pain * Persistent chronic/intractable neuropathic pain that is moderate to severe (VAS ≥4) * 50% or greater pain reduction after receiving SOC ultrasound-guided lidocaine injection * Able and willing to provide consent Exclusion Criteria: * Non-LE amputees * LE amputees without moderate to significant pain * LE amputees who have not undergone TMR, RPNI, or similar nerve targeted surgeries, ampute…
The Altius system will be surgically implanted into the patient on one occasion. The Altius system is then used on an 'as needed' basis by patient.
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