Thalamic Recordings in Children Undergoing SEEG
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Single pulse electrical stimulation (SPES):
研究概览
简要总结
Stereoelectroencephalography (SEEG) forms a key part of the pre-surgical evaluation in children who may be candidates for epilepsy surgery. It can help delineate the location of the putative epileptogenic zone, guiding further treatments including resective, disconnective and ablative epilepsy surgery techniques. However, less than 35% of children undergoing SEEG end up becoming seizure free following further treatment.
Open and closed loop stimulation of thalamic nuclei via deep brain stimulation (DBS) and responsive neurostimulation (RNS) are emerging treatment options for epilepsy. Thalamic target nuclei vary between studies and there are currently no gold standard personalised methods for choosing a target. This stems from the limited systematic neurophysiological recordings from thalamic nuclei; investigators currently do not understand the ictal and interictal thalamic signatures of involvement in epilepsy and do not understand how functional connectivity can be altered within and between patients.
In this prospective study, the investigators aim to recruit 30 patients undergoing SEEG as part of their pre-surgical evaluation for drug resistant epilepsy at Great Ormond Street Hospital over a period of 3 years. Once recruited, the investigators will target 3 nuclei bilaterally in each patient - the anterior, centromedian and pulvinar nuclei - using additional SEEG electrodes. Following clinical recording, the investigators will conduct two stimulation experiments, the first using single pulse electrical stimulation to measure effective connectivity between the thalamus and cortical regions and the second to study the effects of simulated DBS currents on cortical local field potential signatures.
This study will lay the foundation for a personalised approach to thalamic neuromodulation for drug-resistant epilepsy by identifying neurophysiological biomarkers of thalamic involvement in epilepsy, paving the way for closed loop neuromodulation strategies that aim to optimise response using these biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children undergoing SEEG as part of their pre-surgical evaluation at GOSH
- •Participants/parents/legal guardian provide informed consent for inclusion
排除标准
- •1) Lack of informed consent
研究组 & 干预措施
Thalamic SEEG
The centromedian, anterior and pulvinar nuclei on each side will be chosen as target for new electrodes.
干预措施: Additional electrodes into bilateral anterior, centromedian and pulvinar thalamic nuclei (Procedure)
结局指标
主要结局
Single pulse electrical stimulation (SPES):
时间窗: Hospital discharge (maximum one month from SEEG implantation)
We will systematically conduct SPES from all cortical and thalamic contacts and record responses in all other contacts. This measures the effective connectivity.
Ictal thalamic involvement
时间窗: Hospital discharge (maximum one month from SEEG implantation)
Experienced neurophysiologists will assess, during ictal activity, whether each of the nuclei are involved in the seizure and, if so, the latency between first cortical contact onset and thalamic nucleus onset.
Epileptogenicity index
时间窗: Hospital discharge (maximum one month from SEEG implantation)
We will quantify ictal involvement by measuring the epileptogenicity index in each nucleus.
Interictal power distribution
时间窗: Hospital discharge (maximum one month from SEEG implantation)
To assess interictal signatures, we will assess power at different frequencies in the nuclei using the 'fitting oscillations \& one over f' (FOOOF) method.
次要结局
- Incidence of bleeding(Hospital discharge (maximum one month from SEEG implantation))