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临床试验/NCT03050931
NCT03050931进行中(未招募)不适用

Imaging Stroke, Epilepsy and Evoked Potentials in the Brain Using Electrical Impedance Tomography

University College, London2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
42
试验地点
2
主要终点
EIT images accuracy

研究概览

简要总结

The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can produce reproducible and accurate images in people with epilepsy compared to existing standards such as MRI, CT or EEG.

Electrical Impedance Tomography is a relatively new medical imaging method, which has the potential to provide novel images of brain function. It is fast, portable, safe and inexpensive, but currently has a relatively poor spatial resolution. It produces images of the internal electrical impedance of a subject with epilepsy using rings of ECG like electrodes on the skin, intracranial electrode mats or deep electrodes implemented surgically as part of clinical assessment. EIT recording will take place in parallel with the routine recording on the ward. Following completion of the recording, the EIT images will subsequently be analysed and compared to other imaging data for accuracy.

详细描述

Electrical Impedance Tomography (EIT) is a novel medical imaging method in which tomographic images are rapidly produced using electrodes placed around the body. The principal applicant's group has demonstrated that EIT can rapidly image functional brain activity in stroke, epilepsy and normal activity in animal models and has developed instrumentation and image reconstruction algorithms which work well in head-shaped tanks.

The principal aim of this research is to optimise and assess accuracy of Electrical Impedance Tomography (EIT) using scalp electrodes, intracranial electrode mats or deep electrodes in imaging epilepsy in human participants. If successful, EIT has the potential to provide a new portable imaging unit. It could be used with scalp electrodes and enable imaging of the onset and propagation of seizures in 3D. Image quality would be better with intracranial electrode mats or depth electrodes that are already implanted in people with severe epilepsy who are being evaluated for epilepsy surgery. For both electrode types, the new 3D information will enable better diagnosis and so targeting of drug treatment. It could also pave the way to suppression of seizures by deep brain electrical stimulation which could transform management in severe intractable epilepsy.It can offer the same benefits in imaging in epilepsy in neonates and infants.

Patients diagnosed with epilepsy will be asked to participate in the epilepsy EIT study, then up to 32 electrodes will be applied on the subjects' scalp or the EIT systems will be linked to the existing EEG video recording systems and EIT will be recorded at the same time using some or all of the available intracranial electrodes. It may also use some scalp EEG electrode placed on the scalp for clinical or research purposes. Following completion of the recording, scalp electrodes and any paste will be removed, the EIT system will be disconnected from the videoEEG. Collected data will be analysed and compared to other imaging data.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient with epilepsy with either active seizures or interictal EEG changes (for scalp electrodes group)
  • Any patient with epilepsy with either active seizures under evaluation for epilepsy surgery (for intracranial electrodes group)
  • Ability to give informed consent

排除标准

  • 未提供

结局指标

主要结局

EIT images accuracy

时间窗: three years

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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