Case study: Development of a real-time, non-invasive monitoring system for the assessment of brain injury
Head injury is the most common cause of death and disability in people age 1–40 years in the UK. A&E departments need to rapidly identify which patients are most at risk from serious intracranial conditions.
Each year, 1.4 million people attend emergency departments in England and Wales with a recent head injury*. In patients with minor or mild brain injuries such as stroke, there is an urgent need to rapidly identify the small percentage of people who may have, or will go on to develop, serious acute intracranial pathologies.
The NIHR Trauma Management MedTech Co-operative collaborated with Cerebrotech Medical Systems in the evaluation of the Cerebrotech Visor, which offers a non-invasive screening solution, improving outcomes for patients while reducing overall healthcare costs.
The Cerebrotech Visor offers a solution to the challenge by providing a fast, non-invasive method of detecting complications in these patients. It uses Volumetric Impedance Phase-shift Spectroscopy (VIPSTM) technology which provides real-time assessment of the brain’s status following strokes and other brain injury, potentially facilitating earlier intervention.
It works by emitting low-energy radio waves that travel through the left and right hemispheres of the brain. As these waves pass through fluid in the brain, their frequency changes. The Visor assesses these changes in frequency, and compares them for the two halves of the brain. If they’re markedly different, it indicates that a stroke has occurred – the greater the difference, the greater the stroke’s severity.
The Visor is robust, portable, and non-invasive, so it can be used as a clinical monitoring instrument in a variety of settings.
The NIHR Trauma MIC has provided a wide range of support to Cerebrotech Medical Systems in its development of the Visor. In collaboration with the Medical Devices Testing and Evaluation Centre, the NIHR Trauma MIC orchestrated a usability study to assess how nursing and clinical staff experienced fitting the device onto a simulated patient. The NIHR Trauma MIC also facilitated a study, in collaboration with Coventry University, to investigate the usability of the device with 16 paramedics (consisting of lecturers and second year paramedic students) within Coventry University’s Science and Health Building’s ambulance simulator facility.
A range of additional support was provided including:
- assisting with applications for grant funding
- advice on the introduction of the Visor into European markets, and associated beta testing
- undertaking a feasibility study in healthy volunteers to determine how changes in head position alter the device readings
- evaluation and risk assessment of the user interface
- and data management, analysis, and user interface recommendations.
The results of the usability work have led to valuable feedback, and ongoing improvements being implemented into the Visor. The Visor is now CE marked and cleared by the US Food and Drug Administration.
*According to NICE Clinical Guideline 176 (2014)