Clinical deployment of wearable functional neuroimaging

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...