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临床试验/NCT07378397
NCT07378397Enrolling By Invitation不适用

Evaluating Novel OPM-magnetoencephalography in Pre-surgical Mapping for Patients With Epilepsy

Aston University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月17日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Comparative localisations of epileptiform activity

研究概览

简要总结

Magnetoencephalography, or "MEG", is a brain-scanning method which has been available for many years. It is used in the UK and worldwide to help patients with epilepsy, who need surgery to resolve their seizures. The MEG scan can help inform the surgeon about where to operate, by mapping the abnormal brain activity caused by epilepsy. During a traditional MEG recording, patients sit very still with their head in a rigid helmet which houses many tiny sensors. This can be uncomfortable, and there are additional problems if the patient is a child, because the helmet is often too big. It is not possible to record useful data from the very youngest children with a traditional MEG scanner.

But there is a new generation of MEG systems, called OPM-MEG, which employ lightweight sensors housed in a kind of hat. The hat can be appropriately sized for children, and the patient can move comfortably. The new systems are also more cost-effective to run. It is important to know whether the accepted clinical protocols for using MEG in planning epilepsy surgery can be directly transferred to OPM-MEG. It is also important to understand how the patient experience compares across systems.

In this project, 20 volunteer patients will be recruited from among those children already having routine pre-surgical MEG recordings Aston University. They will be invited to participate in an OPM-MEG recording in the same facility at Aston University, so that data from the new OPM-MEG device can be compared with the data from the old MEG scanner. Data analysis pipelines will be streamlined, and the accuracy of the results compared to determine whether the improved sensor arrangement for children in the OPM-MEG system leads to better localisation of epileptiform activity.

详细描述

  1. BACKGROUND

Magnetoencephalography (MEG) is a non-invasive brain imaging technique which offers unique, non-redundant clinical information in the planning of surgery for patients with epilepsy. The MEG data are used to localise the inter-ictal activity that in turn can help formulate hypotheses on the localisation of the seizure onset zone. Better outcomes are associated with earlier surgery (i.e., when a child is younger), and with greater preservation of functional tissue. Aston IHN has been offering a MEG service to children and adults awaiting neurosurgery for two decades.

MEG works by measuring the magnetic fields that indicate the electrical signatures of neural populations acting in synchrony. The established MEG technology relies on cryogenic cooling of the sensors to obtain very high sensitivity, and therefore traditional MEG devices are bulky with a rigid helmet, and also expensive to run. The patient is required to remain very still during the recording, which can be uncomfortable especially for children. Furthermore, the majority of MEG systems worldwide are designed for adult-sized heads and provide poor signal to noise ratios in younger patients.

There is a new generation of MEG systems called OPM-MEG systems. With a different sensor design, these "wearable" devices operate at or near room temperature and make use of a lightweight helmet or hat that can allow the patient to move during recordings and can be sized appropriately for any age. In theory, OPM-MEG promises better data quality, because sensors are closer to the head (increasing signal), and may improve the efficacy of MEG as a pre-surgical diagnostic tool by increasing spatial resolution and inter ictal discharge detection.

The aim of this research is to enable the direct comparison of OPM-MEG with traditional (cryogenic) MEG, so that it can be determined whether the new OPM-MEG technology offers the same benefits to patients. Specifically the aim is to record data on both devices, for a small series of 20 cases, and to develop parallel analysis routines to compare the accuracy of the results obtained from each device. 2. RATIONALE OPM-MEG devices employ different sensor technology from traditional cryogenic MEG systems; also, the sensors are also placed closer to the scalp, and in a less dense configuration. There are additional variations in sensor properties such as signal to noise ratio which when coupled with variations in sensor placement can alter the detectability of brain signals. Furthermore, interpretation of MEG data relies on analysis software pipelines, the vast majority of which have been developed for cryogenic MEG.

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
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All patients referred to the Aston IHN MEG service from Birmingham Children's Hospital Children's Epilepsy Surgery Service, who are between the ages of 6 and 15, are eligible to take part in the study, until 20 patients have completed the study.
  • Inclusion criteria for patients
  • Patients who are capable of giving informed assent, and have a person with parental responsibility capable of giving informed consent on their behalf.
  • Male or female.
  • Patients between the age of 6-15 years
  • Patients and caregivers with English language skills that enable informed assent/consent.

排除标准

  • for patients
  • Patients, or parent or caregiver, who do not assent or consent to participate in the research either on that day or later.

研究组 & 干预措施

Children with epilepsy

Children with refractory epilepsy who are candidates for neurosurgery and have been referred for a clinical MEG scan.

结局指标

主要结局

Comparative localisations of epileptiform activity

时间窗: Within 3 months of referral

Interictal epileptiform activity recorded in the OPM-MEG data will be localised with standard techniques, and resulting brain activity maps compared with those obtained in cryogenic MEG data that is shared into the study.

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 (1)

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