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
- 1
- 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)
研究组 & 干预措施
Burst3D
This is a device progamme setting which is being compared against DR6-LF.
Intervention for this arm is the dorsal root ganglion neurostimulation device implant which will occur at trial implant. Once device is implanted participants are assigned progammes in a randomized manner.
干预措施: Dorsal Root Ganglion Stimulation (Device)
DRG-LF
This is a device progamme setting which is being compared against Burst3D.
Intervention for this arm is the dorsal root ganglion neurostimulation device implant which will occur at trial implant.Once device is implanted participants are assigned progammes in a randomized manner.
干预措施: Dorsal Root Ganglion Stimulation (Device)
结局指标
主要结局
Pain VAS
时间窗: 12 Months
To assess improvements in pain
次要结局
- Preference Questionnaire(26 Days)
- Collection of healthcare utilization data(12 Months)
- 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)