Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT 2)
概览
- 阶段
- 不适用
- 干预措施
- Nalu Neurostimulation System for PNS
- 疾病 / 适应症
- Peripheral Neuralgia
- 发起方
- Nalu Medical, Inc.
- 入组人数
- 185
- 试验地点
- 17
- 主要终点
- Effectiveness: Responder Rates between the 2 groups
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
详细描述
Multi-center, prospective, open-label, randomized controlled trial (RCT) comparing PNS plus CMM with CMM alone. Subjects will be randomized to receive: Arm 1: Nalu Neurostimulation System for PNS plus CMM Arm 2: CMM alone Consented subjects will receive a baseline evaluation and then be randomized 2:1 into one of two arms: 1) PNS+CMM arm or 2) CMM arm. Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices. Those subjects who pass the trial implant will receive the permanent implant. At the 3-month end point, subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant. All Arm 1 patients receiving a permanent implant will be followed for a total of 36 months after permanent implantation.Arm 2 patients who do not crossover will be followed for a total of 36 months from randomization.
研究者
入排标准
入选标准
- •Subject is between 18 to 80 years of age at the time of enrollment.
- •Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
- •Subject has been diagnosed with one or more of the conditions listed below in the low back, shoulder, knee, or foot (including ankle):
- •Post-surgical/post-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment
- •Mononeuropathy, specified or unspecified or in diseases classified elsewhere
- •Other neuralgia or neuropathic pain
- •Osteoarthritic pain
- •Subject has chronic (defined as at least 6 months duration), intractable peripheral neuropathic pain, exclusive of the craniofacial region; any nociceptive pain must be less prominent than the neuropathic pain. Pain should have a predominant neuropathic component as per the investigator's clinical assessment.
- •Subject should have a pain score of at least 6, in the target area of pain, as recorded on the BPI-Q5 (NRS) at screening.
- •Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
排除标准
- •Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- •2\. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- •3\. Pain is completely absent at rest.
- •Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor/sensory polyneuropathy.
- •5\. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
- •6\. Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.
- •7\. Uncontrolled depression or uncontrolled psychiatric disorders
- •Subject is currently participating in another clinical investigation with an active treatment arm.
- •9\. Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.
- •10\. Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.
研究组 & 干预措施
PNS Therapy plus Conventional Medical Management (CMM)
Subjects in this arm will receive a peripheral nerve stimulator and conventional medical management
干预措施: Nalu Neurostimulation System for PNS
PNS Therapy plus Conventional Medical Management (CMM)
Subjects in this arm will receive a peripheral nerve stimulator and conventional medical management
干预措施: Conventional Medical Management
Conventional Medical Management
Subjects will receive only CMM
干预措施: Conventional Medical Management
结局指标
主要结局
Effectiveness: Responder Rates between the 2 groups
时间窗: 3-months
Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the Numeric Rating Scale (0-10; 0=no pain, 10=worst pain imaginable)
Safety: Rate of serious and non-serious device effects
时间窗: 3-months
Rate of serious and non-serious adverse device events between groups
次要结局
- Responder Rates(6-months,12 months, 24 months and 36-months)
- Functional Outcomes: Change in Oswestry Disability Index (ODI) score from baseline to protocol defined timepoints(3 months, 6-months,12 months, 24 months and 36-months)
- Functional Outcomes: Change in Beck's Depression Inventory (BDI) score from baseline(3 months, 6-months,12 months, 24 months and 36-months)
- Functional Outcomes: Patient Global Impression of Change (PGIC)(3 months, 6-months,12 months, 24 months and 36-months)
- Safety Assessment(6-months,12 months, 24 months and 36-months)