Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

Официальное название

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)

Обзор

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.

Вмешательства

• Устройство Surgical 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.

Первичные конечные точки

• Change in Hours Per Day of Prosthesis Use [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in Days Per Week of Prosthesis Use [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in Prosthesis Function Level [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in Prosthesis Satisfaction Level [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in Locomotor Capabilities Index (LCI-5) Score [Срок оценки: Baseline, Month 1, Month 3, Month 6]

Вторичные конечные точки (7)

• Change in Patient Health Questionnaire-9 (PHQ-9) Score [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in Visual Analogue Score (VAS) - Residual Pain [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in Visual Analogue Score (VAS) - Phantom Pain [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Change in PROMIS Pain Intensity Short Form 8a Score [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Number of Participants Taking Opioids/Narcotics for Pain [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Number of Participants Taking Medication for Nerve Pain [Срок оценки: Baseline, Month 1, Month 3, Month 6]
• Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain [Срок оценки: Baseline, Month 1, Month 3, Month 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07571239 · 26-00331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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