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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Hours Per Day of Prosthesis Use
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Adult Lower Extremity (LE) Amputees
Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery.
干预措施: Surgical Implantation (Device)
结局指标
主要结局
Change in Hours Per Day of Prosthesis Use
时间窗: Baseline, Month 1, Month 3, Month 6
Participants provide their average hours per day of prosthesis use over the past 7 days.
Change in Days Per Week of Prosthesis Use
时间窗: Baseline, Month 1, Month 3, Month 6
Participants provide their average number of days of prosthesis use over the past 7 days.
Change in Prosthesis Function Level
时间窗: Baseline, Month 1, Month 3, Month 6
Participants rate their current level of function with their prosthesis on a scale from 1 (extremely low) to 10 (extremely high).
Change in Prosthesis Satisfaction Level
时间窗: Baseline, Month 1, Month 3, Month 6
Participants rate their current level of satisfaction with their prosthesis on a scale from 1 (extremely dissatisfied) to 10 (extremely satisfied).
Change in Locomotor Capabilities Index (LCI-5) Score
时间窗: Baseline, Month 1, Month 3, Month 6
14-item assessment of locomotor capabilities; each item is rated on a 5-point scale from 0 to 4; the total score is the sum of responses and ranges from 0-56; higher scores indicate greater locomotor capabilities.
次要结局
- Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain(Baseline, Month 1, Month 3, Month 6)
- Change in Patient Health Questionnaire-9 (PHQ-9) Score(Baseline, Month 1, Month 3, Month 6)
- Change in Visual Analogue Score (VAS) - Residual Pain(Baseline, Month 1, Month 3, Month 6)
- Change in Visual Analogue Score (VAS) - Phantom Pain(Baseline, Month 1, Month 3, Month 6)
- Change in PROMIS Pain Intensity Short Form 8a Score(Baseline, Month 1, Month 3, Month 6)
- Number of Participants Taking Opioids/Narcotics for Pain(Baseline, Month 1, Month 3, Month 6)
- Number of Participants Taking Medication for Nerve Pain(Baseline, Month 1, Month 3, Month 6)