Reversal of EEG Theta Rhythm as an Objective Measure of Efficacy of Spinal Cord Stimulation in Chronic Neuropathic Pain - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The reduction in theta (4-7 Hz) power
研究概览
简要总结
We want to assess if reversal in EEG theta power during trial phase can serve as an objective marker for sustained clinical response, identifying true responders, and if the changes in EEG pattern during trial with three modalities can help in selection of SCS modality best suited to a given patient.
详细描述
The aim of the study is to see if reversal in EEG theta power during trial period can predict a sustained response (At 6 months post implantation) and thus serve as a n objective measure for SCS efficacy in a given patient- thus objectively identifying true responders.
Additionally, this study aims to see if spinal profile of baseline EEG abnormality as well as EEG response to a given SCS modality during trial period, alongside clinical correlation, can help in selection of SCS modality best suited to a given patient.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (Aged 18 years or above and able to consent) with failed back surgery syndrome leading to neuropathic leg/back pain deemed suitable for spinal cord stimulation trial
排除标准
- •Patients with history of epilepsy or epileptiform disorders
研究组 & 干预措施
Reversal in EEG Theta power during trial period
干预措施: Reversal in EEG Theta Power (Device)
结局指标
主要结局
The reduction in theta (4-7 Hz) power
时间窗: Up to day 11 following trial lead implementation
Used to differentiate responders from non-responders
次要结局
- Spatial profile of EEG changes(Up to day 11 following trial lead implementation)
- reduction in short and mid latency amplitude on SSEP(Up to day 11 following trial lead implementation)