TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain: Clinical Efficacy and Procedural Efficiency
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pain VAS
研究概览
简要总结
This a single center study comparing two forms of electrical stimulation: sub-sensory burst stimulation (DRG-Burst3D) and standard low frequency stimulation (DRG-LF) in the dorsal root ganglion of subjects diagnosed with neuropathic pain
详细描述
The study will consist of two phases; a 26 day randomized trial phase in which the subject will assess the effectiveness of DRG-Burst3D and DRG-LF, and a 12 month post permanent implant follow up phase.
The randomized trial phase which consists of two phases Trial Assessment 1 and Trial Assessment 2 will last for a maximum of 26 days. Subjects will be randomized 1:1 to receiver 10 ±3 days of DRG-LF stimulation and 10 ±3 days of Burst3D stimulation (DRG-Burst3D) to assess the efficacy of each the different forms of stimulation throughout the trial phase.
Subject will complete in clinic questionnaires (SF-36, ODI, DN4, PGIC, Paraesthesia Map) during the trial phase along with multi-day diary to record VAS pain scores. The subject-reported data from multi day diary and in-clinic assessments will be the basis of verification for success of trial (> 50% overall pain relief). Following device trial subjects will take a questionnaire on program preferences of DRG-LF or Burst3D.
If VAS score during either of the two trial assessments is reduced by at least 50% compared to the baseline score, the subject will be considered for permanent DRG-SCS implant. Subjects who do not experience a >50% overall pain relief on either of the two stimulation settings will exit the study.
Subject who underwent a successful trial (> 50% overall pain relief) will then be implanted with Boston scientific Precision NoviTM neurostimulator trial System. Post permanent implant subjects will receive both DRG-LF and Burst3D programs and use their preferred stimulation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Subject is at least 18 years old at the time of informed consent
- •Subject is willing and able to provide a signed and dated informed consent
- •Subject is capable of independently comprehending and consenting to the requirements of the study
- •Subject is willing and able to comply with all study procedures, study visits, and be available for the duration of the study
- •Subject has been diagnosed with Neuropathic Pain with VAS pain scores ≥ 6 for at least 6 consecutive months
- •Pain distribution localized predominantly to 1 or 2 body dermatomes
- •Subject is on a stable dose (no new, discontinued or changes) of all prescribed pain medications for at least 4 weeks prior to screening and willing to maintain or only decrease the dose of all prescribed pain medications through Trial Assessment
- •Subject has tried appropriate conventional medical management for their pain
排除标准
- •Subject has an active implanted device, whether turned on or off
- •Subject displays current signs of a systemic infection
- •Subject is pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
- •Subject has untreated major psychiatric comorbidity
- •Subject has serious drug-related behavioural issues (eg, alcohol dependency, illegal substance abuse)
- •Using greater than 120mg morphine equivalents of opioids daily
- •Structural abnormalities of the spine that may prevent electrode implantation
- •Co-existing disorder of the nervous system that may affect study measurements e.g polyneuropathy
- •Subjects has a requirement for planned MRI scanning in the future
- •Subject is diagnosed with Raynaud disease
- •Subject is diagnosed with Fibromyalgia
- •Subject has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
- •Subject has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
- •Subject is participating or planning to participate in another clinical trial
- •Subject has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
结局指标
主要结局
Pain VAS
时间窗: 12 Months
To assess improvements in pain
次要结局
- Collection of healthcare utilization data(12 Months)
- Preference Questionnaire(26 Days)
- Douleur Neuropathique 4 questionnaire(1 Month)
- The Short Form 36 Health survey(12 Months)
- EuroQol five dimensions questionnaire(12 Months)
- 7 day pain diary(12 Months)
- Pain Map(Baseline)
- Paraesthesia Map(12 Months)
- Oswestry Disability index(12 Months)
- Patient Global Impression of Change(12 Months)
- Patient Satisfaction questionnaire(12 Months)