Prospective, Longitudinal, Single-arm Interventional Study Evaluating the Efficacy of Spinal Transforaminal NeuroStimulation (STNS) With FAST and MULTIWAVE Stimulation in Patients With Refractory Chronic Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index.
研究概览
简要总结
The goal of the study is to demonstrate Spinal Transforaminal NeuroStimulation effectiveness with FAST and other waveforms / combinations to relief neuropathic peripheral pain in chronic neuropathic pain patients, at low risk and low energy consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has ≥ 18 years and ≤ 80 years
- •Subject has a global Visual Analogic Scale ≥ 5
- •Subject has non-cancer pain with a significant neuropathic component for at least 6 months.
- •Subject has stable pain for at least 30 days
- •Pain medication(s) dosage(s) is/are stable for at least 30 days
- •Subject is eligible for Spinal Transforaminal NeuroStimulation after a pre-implantation assessment by a multidisciplinary team, as described by the French National Authority for Health (Haute Autorité de Santé)
- •Subject understands and accepts the constraints of the study and is able to use the equipment.
- •Patient is covered by French national health insurance.
- •Subject has given written consent to the study after having received clear and complete information.
- •Non-inclusion Criteria:
- •Subject has a coagulation disorder
- •Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system
- •Subject has had corticosteroid therapy within the past 30 days
- •Subject has had radiofrequency therapy within the past 3 months
- •Subject has been diagnosed with cancer in the past 2 years
- •Subject has had a spinal surgery within the past 6 months
- •Simultaneous participation to any interventional study on health product or any study able to interfere with the current study endpoints.
- •Subject has at least one of brain MRI contraindications such as : intracranial clips /Vascular clips/Pace maker/Heart battery, Defibrillator, Implanted Holter (REVEAL type), Neuro-stimulator not compatible with 1.5 T MRI/Stents/ Coils/Cardiac valves (heart)/ Shunt valve/Implanted injection pump/Cochlear implants/Implantable chamber (PAC)/Intracorporeal metal shards/ metallic foreign bodies, the location and the presence of implanted neurostimulation components that are not listed as MRI Conditional, cardiac implantable electronic device, metallic intraocular foreign bodies, cochlear implants, drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid, piercing.
- •Subjects requiring closer protection, i.e. minors, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting
- •Pregnant or breastfeeding women, women at age to procreate and not using effective contraception.
排除标准
- 未提供
研究组 & 干预措施
Lead(s) implantation, 7days trial phase, Implantable Pulse Generator implantation
One or two 8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. This will be followed by a trial phase for a period of 7 days in order to assess the benefits of stimulation. Patients who succeeded the trial phase (at least 30% reduction of leg pain measured with a 5-day pain diary) will be implanted with a permanent system (Implantable Pulse Generator).
At first, all patients will be programmed under FAST stimulation for at least 24h to fully perceive its efficacy. If the patient is satisfied with FAST then the patient will continue with this program but if the patient is not satisfied, then the patient could switch to other waveforms that will be pre-programmed during the visit including conventional and microburst stimulation.
干预措施: Lead(s) and Implantable Pulse Generator implantation (Device)
结局指标
主要结局
The primary outcome for evaluating pain-related health is the mean absolute change in Multidimensional Clinical Response Index.
时间窗: 6 months
The Multidimensional Clinical Response Indexwas previously developed and validated to evaluate the pain-related health state of PSPS-T2 patients. This weighted composite outcome includes pain intensity, functional disability, quality of life, psychological distress and pain mapping surface. The Multidimensional Clinical Response Indexis a score that ranges from 0 (worst pain-related health status) to 10 (best pain-related health status). The score has been used in several studies evaluating efficacy of different neurostimulation modalities.
次要结局
- Absolute change in pain intensity between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.(6 months)
- Evaluation of patient satisfaction at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.(6 months)
- To evaluate the effects of Spinal Transforaminal NeuroStimulation on neuropathic pain symptoms.(6 months)
- Surface (cm²) of each symptom calculated using the Pain mapping software.(6 months)
- To characterize the Spinal Transforaminal NeuroStimulation neural targeting based on 3D-imaging and electrophysiological exploration in order to precisely identify the optimal paresthesia-based neural target locations.(6 months)
- Rate of serious and non-serious adverse events and device deficiencies will be reported.(6 months)
- Rate of patients undergoing FAST stimulation (exclusively or in combination with other waveforms) at 6-month follow-up.(6 months)
- Mean absolute change in Multidimensional Clinical Response Index for the subgroup of patients undergoing FAST at 1-, 3- and 6-month follow-ups.(6 months)
- Absolute change in pain surface between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.(6 months)
- Absolute change in health related quality of life between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.(6 months)
- Absolute change in functional disability between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.(6 months)
- Absolute change in anxiety and depression between baseline and 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation follow-up.(6 months)
- Evaluation of energy consumption at 1-, 3- and 6-month post-Spinal Transforaminal NeuroStimulation.(6 months)