EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Functional connectivity
研究概览
简要总结
This study is an interventional, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome patients with back and leg pain.
详细描述
Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication.
Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.
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 65 Years（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.
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain.
- •Cognitive and language functioning enabling coherent communication between the examiner and the subject;
- •Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
- •Stable neurologic function in the past 30 days
- •In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
- •Subject is able to provide written informed consent
- •Subject speaks Dutch or French.
排除标准
- •Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
- •Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- •Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
- •Subject is unable to operate the device or has no relative available.
- •Subjects with indwelling devices that may pose an increased risk of infection
- •Subjects currently has an active infection
- •Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
- •Subject has participated in another clinical investigation within 30 days
- •Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- •Subject has been diagnosed with cancer in the past 2 years
- •Life expectancy < 6 months
- •Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
- •Existing extreme fear for entering MRI
- •General contraindication for MRI (pacemaker, etc...)
- •Age male/female patient <18 years
研究组 & 干预措施
spinal cord stimulation
干预措施: EEG recording + pain protocol (Other)
结局指标
主要结局
Functional connectivity
时间窗: The change between baseline and 1 month after definitive implantation of the neurostimulator
EEG recordings to measure functional connectivity in the brain
次要结局
- Functioning of the descending inhibitory pathway(The change between baseline and 1 month after definitive implantation of the neurostimulator)
- Visual Analogue Scale (VAS) pain diary(Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion).)
- Pain Catastrophizing(The change between baseline and 1 month after definitive implantation of the neurostimulator)
- Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).(The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).)
- Subjective sleep quality(The change between baseline and 1 month after definitive implantation of the neurostimulator)
研究者
Moens Maarten
Prof. dr.
Universitair Ziekenhuis Brussel