Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain

Nalu Medical, Inc.13 个研究点分布在 1 个国家目标入组 89 人2022年2月23日

适应症Peripheral Neuralgia Chronic Pain

干预措施Nalu Neurostimulation System for PNS conventional medical management

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: 89
试验地点: 13
主要终点: Effectiveness: Responder rates between groups
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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 post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

注册库

clinicaltrials.gov

开始日期

2022年2月23日

结束日期

2026年9月30日

最后更新

上个月

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Nalu Medical, Inc.

责任方

Sponsor

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.
•Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
•Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
•Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.
•Subject has demonstrated the ability to appropriately place the adhesive clip in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and/or limb cuff to keep the Therapy Disc in place.

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.
•Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant)
•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.
•Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
•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.
•Uncontrolled depression or uncontrolled psychiatric disorders
•Subject is currently participating in another clinical investigation with an active treatment arm.
•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.
•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

peripheral nerve stimulator plus conventional medical management

干预措施: Nalu Neurostimulation System for PNS

PNS Therapy plus Conventional Medical Management

peripheral nerve stimulator plus conventional medical management

干预措施: conventional medical management

Conventional Medical Management

Control arm conventional medical management only

干预措施: conventional medical management

结局指标

主要结局

Effectiveness: Responder rates between 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 BPI-Q5 (NRS).

Safety: Rate of serious and non-serious adverse events between groups

时间窗: 3-months

Rate of serious and non-serious adverse events between groups

次要结局

Responder Rates between groups at 6-months(6 months)
Responder Rates between groups at 12-months(12-months)
Responder Rates between groups at 24-months(24-months)
Responder Rates between groups at 36-months(36-months)
Functional Outcomes: Change in ODI, BDI, EQ-5D, BPI from baseline(3, 6, 9, 12, 18, 24, 30 and 36 months)
Safety Assessment(3, 6, 9, 12, 18, 24, 30 and 36 months)