Title: Development and clinical study of a wearable brain imaging device to detect intracranial bleeding at the point of care
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: Head injuries are the most common cause of death in patients younger than 45 years. Head injuries are also common among those who are at particular risk of falls, such as the elderly and frail. For head injuries, faster treatment reduces the chance of disability and death for the patient. 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 are developing a wearable headcap that can create a map of blood within the head to detect head injuries and see the extent of any injury. By providing portable, low-cost brain imaging, we help clinicians to save costs and lives. The technology uses infrared light and has been used within neuroscience research for 30 years, but until now it has not had the resolution for useful medical imaging. Cortirio are increasing the resolution and have demonstrated our imaging on the benchtop. This project will take our benchtop technology and turn it into a wearable headcap that we can take into the clinic. In the first part of the project, we will design and manufacture the headcap, focussing on product design challenges such as adapting it to fit to heads of different sizes and shapes. We will test the device first with healthy adult volunteers in a non-clinical setting to improve the comfort and ease of use. In the second part of the project, we will run a clinical study with patients with bleeding in their head. A comparison of Cortirio s device will be made to CT scans (the current gold standard for detecting bleeding in the head). We will use objective measures of image accuracy and make a preliminary assessment of the device s accuracy for detecting bleeding within the head. Using data gathered from this study, we will assess potential cost savings from our device across the NHS. We have an existing patient and public involvement group and will continue working with them in this project to feed back on the product design, clinical study and real-world use. 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.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: INJURIES AND ACCIDENTS