A Single-Center, Prospective, Within-Subject Study of Altius® Direct Electrical Nerve Stimulation System in Lower Extremity Amputees With Persistent Pain After Targeted Muscle Reinnervation (TMR) and/or Regenerative Peripheral Nerve Interface (RPNI)
NYU Langone Health
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceSurgical Implantation
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.
Location
- NYU Langone HealthNew York, New York