Development and clinical study of a wearable brain imaging device to detect intracranial bleeding at the point of care

Research Question Does the Vascascope enable accurate imaging of extradural and subdural haematomas in a patient at the point of care?

Background Traumatic Brain Injuries (TBIs) are those caused by an impact such as in road traffic accidents, falls, sports and violence. TBIs are the leading cause of death in patients younger than 45-years. Fast treatment reduces the chance of death and disability for patients with head injuries.

Unfortunately, many head injuries are not recognised within the vital early hours because the equipment needed to diagnose bleeding in the head is expensive and not portable.

Cortirio have developed a low-cost, wearable device (Vascascope) which, through the use of Near Infrared Spectroscopy (NIRS) enables patients' heads to be scanned at point of care and detect, image and monitor bleeding within the head.

Vascascope has been demonstrated on optical phantoms, imaging bleeds from 5 mm to 30 mm wide and 2 mm thick through a 12 mm thick layer of skull.

Aims and Objectives Building on an i4i Connect project which miniaturised the optics and electronic components, the i4i PDA project aim is to build a wearable prototype and clinically test the device. Methods The wearable device will be designed with clinical and PPI input.

We will test the device first with healthy adult volunteers in a non-clinical setting to improve the comfort and ease of use. Imperial College will conduct a clinical study (60 patients) comparing Vascascope with CT. Health economic analysis will be undertaken and regulatory approval obtained.

Impact This project will produce a headcap capable of imaging bleeding within the head, that hospital and ambulance services can use to detect head injuries at the bedside or the roadside. We will get regulatory approval for the device so that the device will be ready for clinical use.