Clinical deployment of wearable functional neuroimaging

了解人类大脑以及影响它的许多疾病，是21世纪医疗保健的主要挑战。扫描技术取得了重大进展，比如核磁共振成像（MRI），它可以非常详细地显示大脑的样子。然而，在许多疾病中，大脑结构看起来正常，常规成像的作用有限。相反，潜在的问题是异常的大脑功能（即脑细胞的功能出了问题）。了解这些功能缺陷意味着测量人类大脑约1000亿个神经元网络的活动。神经元通过向彼此发送小的电脉冲来工作。这些脉冲产生磁场，磁场穿过颅骨。如果我们能够测量和解释这些领域，我们就获得了一个了解大脑功能的窗口。这个过程被称为脑磁图（MEG）：当我们进行一项心理任务时，MEG扫描可以让我们精确地测量出参与其中的大脑区域以及它们的相对时间。这在临床上很有用；例如，在癫痫中，它使我们能够绘制出负责癫痫发作的大脑区域。不幸的是，MEG并没有被广泛采用，因为：1)扫描仪非常昂贵；2)扫描仪的性能有限；3)病人必须长时间保持静止不动；扫描仪对儿童没有多大用处。Cerca Magnetics已经用一种全新的MEG系统解决了这些问题，这种系统就像头盔一样戴着。不同的尺寸意味着可以容纳儿童，婴儿或成人，并且一个轻量级的头盔允许患者在扫描过程中移动。扫描质量提高，系统成本降低50%。这些发展为实现MEG作为强大临床工具的潜力提供了一个独特的机会。然而，关键的是，该系统需要监管部门批准才能用于人类。在这里，我们试图通过收集所需的大量信息来加快这一进程。我们将:1。**证明系统的安全性，并完成所有文件以确保人类使用的合规性。**构建设备以确保系统准确性**在使用前启用系统验证。**在人体中测试该系统**以证明其优于现有扫描仪。**通过显示我们可以准确地绘制异常脑组织来展示在癫痫中的临床应用**。成功将使Cerca获得监管部门的批准，从而使我们能够将一种新的临床工具推向市场。这将推动英国在成像技术方面处于全球领先地位，最重要的是为许多患有极度衰弱的神经系统疾病的人带来新的希望。

Understanding the human brain, and the many disorders that affect it, is a major challenge for 21st century healthcare. Significant progress has been made by scanning technologies, like MRI, which show what the brain looks like in exquisite detail. However, in many disorders brain structure looks normal and conventional imaging is of limited use. Instead, the underlying problem is aberrant brain function (i.e. what brain cells _do_ goes wrong). Understanding these _functional_ deficits means measuring activity in the human brain's network of ~100 billion neurons.Neurons work by sending small electrical impulses to one another. These impulses create magnetic fields, which pass through the skull. If we can measure and interpret these fields, we gain a window on brain function. This process is called magnetoencephalography, or MEG: when we undertake a mental task, a MEG scan allows us to measure precisely which brain areas were involved and their relative timings. This is useful clinically; e.g. in epilepsy it allows us to map brain regions responsible for seizures.Unfortunately, MEG has not been widely taken up because: 1) the scanners are incredibly expensive; 2) performance of scanners is limited; 3) patients have to remain very still for long periods; 4) scanners are of little use in children. Cerca Magnetics have solved these problems with a completely new type of MEG system, worn like a helmet. Different sizes mean children, babies or adults can be accommodated, and a lightweight helmet allows patients to move during scanning. Scan quality is increased, and the system cost is decreased by 50%.These developments offer a unique opportunity to realise the potential of MEG as a powerful clinical tool. However, critically, the system needs regulatory approval for human use. Here, we seek to fast-track this process by amassing the body of information required. We will:1. **Demonstrate the safety** of the system and complete all documentation to ensure compliance for human use.2. **Build devices to ensure system accuracy** enabling system validation prior to use.3. **Test the system in humans** to prove benefits over existing scanners4. **Demonstrate clinical utility** in epilepsy by showing that we can accurately map aberrant brain tissue.Success will allow Cerca to attain regulatory approval allowing us to bring a new clinical tool to market. This will propel the UK to a global lead in imaging technology, and most importantly offer new hope to many suffering from extremely debilitating neurological conditions.