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临床试验/NCT03916848
NCT03916848Unknown不适用

Novel Network Analysis of Intracranial Stereoelectroencephalography

Great Ormond Street Hospital for Children NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Correlate firing activity of single units to the clinically defined seizure onset zone (SOZ)

研究概览

简要总结

Epilepsy is a disorder of the brain which is associated with disabling seizures and affects 100,000 people under 25. Many children with epilepsy also have a learning disability or problems with development. Although better outcomes occur in children who are successfully treated early for their epilepsy, 25% continue to have seizures despite best medical treatment.

One potential treatment is a neurosurgical operation to remove parts of the brain that generate seizures. A proportion of these children have electrodes inserted into their brains as part of their clinical assessment, termed stereoelectroencephalography (SEEG), to help localise these regions. Subsequent surgery is not always successful - up to 40% of children will have ongoing seizures 5 years after surgery.

The purpose of this study is to assess the utility of specially designed SEEG electrodes which can measure signals from single brain cells. These electrodes record the same clinical information as normal SEEG electrodes and are implanted in the same way, but can give the research team extra information at the same time. The investigators aim to assess whether studying the changes in the firing of individual cells, both during and between seizures, improves our ability to localise seizures and therefore improve outcomes following surgery.

As part of this research project, the investigators will not be doing anything that is not already part of the normal investigation and treatment for these children. Children will be recruited to the study during routine outpatient clinic visits. Surgical planning and execution will not be affected. The electrodes are CE licensed for clinical use and do not alter the risks of the operation. Following the period of monitoring, the care of these children would not be altered in any way.

The investigators aim to recruit 30 patients over 3 years. In addition to dissemination via scientific publications and presentations, the findings will be shared with participants and the public.

详细描述

Hypothesis

The hypothesis is that analysis of ictal (during seizure) and interictal (between seizures) single neuronal firing dynamics will identify ictogenic tissue in children undergoing SEEG recording for focal epilepsy.

Study Design

Prospective cohort study.

Sample Size

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing SEEG recording as part of the investigation of their epilepsy at Great Ormond Street Hospital for Children
  • Aged 3-18
  • Participant/parents provide informed consent for inclusion

排除标准

  • Lack of informed consent

结局指标

主要结局

Correlate firing activity of single units to the clinically defined seizure onset zone (SOZ)

时间窗: Recording will continue for a period of 5-10 days, as determined by the clinical team. We will therefore use the data collected over the entire recording period for analysis.

Currently, the seizure onset zone (SOZ) is determined by visual analysis of the SEEG recordings at the end of the monitoring period. We aim to compare the differences in single unit behaviour (as defined above) between and during seizures in neurons inside and outside this clinically defined SOZ to assess if there is a unique behaviour to these neurons.

Analyse single unit behaviour in different brain regions.

时间窗: Recording will continue for a period of 5-10 days, as determined by the clinical team. We will therefore use the data collected over the entire recording period for analysis.

We will assess the abnormalities in single neuron firing behaviour both during and between seizures in children undergoing stereoelectroencephalogaphy (SEEG) as part of work-up for epilepsy surgery. The statistical analysis will include measures of timing coding and population coding of these single units and the investigators will assess these properties in time periods both during and between seizures to assess whether neurons in the seizure onset zone behave differently to those outside the seizure onset zone: 1. Timing coding is evaluated using a generalized linear modeling (GLM) approach. An output of the GLM is called a post-spike filter (PSF), which models the propensity for the same neuron to fire again over the course of the subsequent 0.7 seconds. 2. Population coding is also evaluated using a GLM by calculating coupling filters (the amount of up and down regulation of all other recorded neurons given that an individual neuron has just fired).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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