Evaluation of the Brain Activity During Spinal Cord Stimulation (SCS) in Failed Back Surgery Syndrome Using Functional Magnetic Resonance Imaging (fMRI) and Magnetic ResonanceSpectroscopy (MRS)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- functional and neurobiological cerebral changes due to SCS
研究概览
简要总结
Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a SCS.
详细描述
In case a patient meets all inclusion and no exclusion criteria, he/she will be implanted with an epidural neurostimulation lead (electrode).
The day of implant will be recorded as day 0 (table 1) and will always be a Thursday.
Post lead implant, the patient will be hospitalized for a small week as per common practice in case of the intervention outside of the study.
During hospital stay, the investigator of the study, or a representative of the product manufacturer, Medtronic®, will search for the optimal stimulation parameters to evoke correct paraesthesia coverage and pain relief. If appropriate parameters have been found, these will be saved in the external neurostimulator.
After maximum one hour, the neurostimulator will be turned off again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age male/female patient ≥ 18 years
- •Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
- •Patient with low back pain and/or pain in at least one leg
- •Pain intensity at baseline assessed by VAS > 5 (50%)
- •Patient willing to provide informed consent.
排除标准
- •Use of spinal cord stimulation in this patient in the past.
- •Presence of other clinically significant or disabling chronic pain condition
- •Expected inability of patients to receive or properly operate the spinal cord stimulation system
- •History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- •Active malignancy
- •Current use of medication affecting coagulation which cannot be temporarily stopped
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- •Life expectancy of less than 1 year
- •Existing or planned pregnancy
- •Existing extreme fear for entering MRI
结局指标
主要结局
functional and neurobiological cerebral changes due to SCS
时间窗: 2 years
To compare brain activity before and after spinal cord stimulation (with appropriate paraesthesia) using functional magnetic resonance imaging and neurobiological changes in the spectrum (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) due to stimulation measured by MRS. The primary outcome is the difference in neurobiology between baseline and when the stimulator is on.
次要结局
未报告次要终点