Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

Starting soon · Not applicable

Conditions studied: Amputation; Lower Extremity, Pain, Persistent Postsurgical

In brief

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.

Key facts

Study ID

NCT07571239

Run by

NYU Langone Health

People needed

32

Starts

2026-07-01

Expected to finish

2028-07-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.