Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

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, amputees who have undergone these surgeries less than 9 months prior to enrollment, or amputees who have undergone these surgeries and do not have persistent pain
• Patients with contraindications to implant surgery

• Presence of any active implantable device (e.g, pacemaker, implantable cardioverter-defibrillator, other neurostimulator or drug pump)
• Anticipated need for MRI or diathermy after implantation
• Uncontrolled diabetes, defined as HbA1c > 8.0 at screening due to increased risk of surgical complications and delayed wound healing
• Pregnant, breastfeeding, intending pregnancy during the study period, or unwilling to use effective contraception
• Suspected or known allergy to any component of the Altius system or to lidocaine used for the diagnostic lidocaine block.
• Severe scarring, skin grafting, or other anatomic constraints over the planned implant site that would prevent safe placement of the cuff electrode(s), lead(s), or IPG
• Spasticity of the residual limb preventing comfortable full range of motion, which may interfere with stability or comfort of the implanted leads.
• Other significant pain syndromes that, in the investigator's judgment, would likely confound assessment of phantom limb or residual limb neuropathic pain outcomes.
• Active substance abuse; severe psychiatric illness that may interfere with study participation (e.g., recent psychiatric hospitalization or other condition that impairs ability to comply with study procedures); or inability to comply with follow up visits or operation of the Altius Direct Electrical Nerve Stimulation System.
• Uncontrolled infection at the amputation site or bleeding disorders
• Unable to operate the Altius® Direct Electrical Nerve Stimulation System
• Unsuitable for the Altius implant surgery
• Unable to participate in follow-ups according to study schedule (1 month, 3 months, and 6 months post-op)