Window into the Mind: Handheld Spectroscopic Eye-safe Device (EyeD) for Neurodiagnostics

Lead Research Organisation: University of Birmingham
Department Name: Chemical Engineering

Abstract

Traumatic brain injury (TBI) is a leading cause of morbidity and mortality worldwide, with a high complication rate requiring long-term care, creates prolonged post-traumatic neurological disorders and is potentially fatal with annual socioeconomic cost in the UK of £7.5 Billion per year. While critical decisions affecting treatment must be made rapidly, TBI is notoriously hard to diagnose pre-hospitalisation, sometimes resulting in incorrect patient management. Timely assessment of injury severity is a priority in the correct treatment of TBI patients. However, this is poorly supported by current technologies, which fall short of the diagnostic needs, exhibiting poor-sensitivity, special-handling requirements and complicated, costly procedures.

A non-invasive portable technique to diagnose and monitor TBI and neurodegenerative diseases is proposed, by measuring changes to the optic nerve, visible at the back of the eye. The optic nerve, bathed in cerebrospinal fluid, which is in continuity with the central nervous system, constitutes an optically clear 'window to the brain'. The aim is to develop a portable technology to detect biochemical changes in cerebrospinal fluid in response to brain injury using specialised optical collected using a technique known as Raman spectroscopy. This provides a non-invasive, highly-sensitive method for the detection of biomarkers in the eye, and yet it can be packaged as a low-cost, hand-held device.

For delivering such a sensitive and rapid diagnostic technology, it is crucial to accurately identify these specialised Raman signals originating from different parts of the eye. To tackle these challenges, advanced computational methods, known as "machine learning", will be developed to embrace the 'noise' from the data and enable a generic framework for intelligent diagnosis. Unlike traditional packages, this method will perform data analysis directly in the web browser using cloud technologies as an open-source. Building upon these, this innovative technology will allow TBI measurements to take place at the point-of-care via a non-ionizing scan of the back-of-the-eye to detect biochemical changes without the need for a painful lumbar puncture (to extract the cerebrospinal fluid) or expensive, dangerous radiological scans.

Our prime objective is to deliver a technology offering improved health, more effective patient-care and a better quality of life for patients suffering from neurotrauma. It will be designed for use on-site by doctors and paramedic crews to provide timely and cost-effective diagnosis and triaging and will be used by ambulance trusts, sports organisations, GPs, hospitals and the Ministry of Defence. Rapid diagnosis in the early-clinical phase in a non-invasive, cost-effective way will lay the platform for a range of improvements in personalised medicine and management. Predominantly focussed on timely TBI-detection, our device would allow for better patient triaging, reducing the strain on the healthcare system. In addition to delivering the timely intervention and organised trauma-care to nearly a million individuals nationally, it will decelerate the patients' cognitive decline, reduce in-hospital mortality, save thousands of lives a year, avoid long-term hospital stays, and reduce a major burden on the NHS and the taxpayer.
 
Description Contribution and Citation in Policy Documents by Canadian Agency for Drugs and Technologies in Health
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in other policy documents
Impact This provided the impact of healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of technologies.
 
Description A smart, multi-purpose technology for diagnostics, analytics and drug delivery
Amount £128,567 (GBP)
Funding ID EP/W004593/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2021 
End 12/2022
 
Description Identification of Filamentous Pathogens in Leaves
Amount £18,000 (GBP)
Organisation Scottish Forestry Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2022 
End 10/2025
 
Description Integrated-Optofluidic Device Technology for Timely Detection of Biochemical Hazards: IDTech (Phase 2)
Amount £73,500 (GBP)
Organisation Defence Science & Technology Laboratory (DSTL) 
Sector Public
Country United Kingdom
Start 06/2021 
End 05/2022
 
Description Knowledge Assets Grant Fund - KAGF Project at the Ministry of Defence 'Prototype portable Spectroscopy and Fundus Camera'
Amount £25,000 (GBP)
Organisation University of Birmingham 
Sector Academic/University
Country United Kingdom
Start 03/2022 
End 03/2023
 
Description MRC CiC: 'Detection of moderate to severe traumatic brain injury in the eye'
Amount £59,874 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 06/2022 
End 06/2023
 
Description Resilient Advanced Portable Integrated Device (RAPID): Towards Development of a Multimodal Technology for Detection of Foodborne Pathogens
Amount £19,700 (GBP)
Organisation British Council 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2022 
End 02/2024
 
Title An implementation of a Kohonen map in JavaScript extended to provide feature extraction and classification 
Description Creation of user-friendly Software for web interface that can be easily accessed from any location, without a need to install or compile a single line of code. 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2021 
Provided To Others? Yes  
Impact By developing and providing both a library and web app available as open source tools, this has addressed the gap of the lack of easily accessible tools, which has previously been cited as a reason for poor adoption of such methods as seen in chemometrics. 
URL https://github.com/cbanbury/kohonen
 
Description Collaboration with Neuro-clinical leads at QEHB 
Organisation Queen Elizabeth Hospital Birmingham Charity (QEHB)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution To ensure that we target this new technology at the most important medical need, we established collaboration with clinicians at the Queen Elizabeth Hospital Birmingham (QEHB) who are now widely consulted with regular contact during the project. By these means we are exploring how the design of the various technology components can be optimised and tailored to deliver the greatest benefit to the widest range of patients. Enlisted clinician(s) are inputting into the design, development and translation of the technology, guiding the work and facilitate ethical approvals and engagement with patient groups (PPIE), from representative cohorts.
Collaborator Contribution -Input into the design, development and translation of the proposed technology. -Facilitating engagement with patient and public involvement groups (PPIE), from representative cohorts at all stages of development. -Coordinating the availability of the human bio-samples of patients with confirmed TBI from the QEHB and Human Tissue Biorepository for the initial clinical assessment of the proposed technology - Expediting and coordinating ethical approvals as well as providing input to the clinical overview and patient context of the study.
Impact This is a multi-disciplinary collaboration including clinicians from neurosurgery, ophthalmology and neurosciences. Outputs to date include: Exploration of how the design of the various technology components can be optimised and tailored to deliver the greatest benefit to the widest range of patients. Engagement with PPIE group and a workshop with trauma patients and carers / family with lived experience of neurological trauma, who highlighted the need of new devices, such as the one we are developing, with particular focus on rapid diagnosis to assist triage for the patient and the NHS benefits, particularly valuing the portability, enabling pre-hospital diagnosis without a scan.
Start Year 2021
 
Description NIHR Trauma Management Healthcare Technology Co-operative 
Organisation NIHR Trauma Management MedTech Co-operative
Country United Kingdom 
Sector Public 
PI Contribution The NIHR Trauma Management HTC we collaborate on the development of new PoC technology and in doing so we will provide engineering know-how expertise and facilitate collaborative working with industry. We engage with the partners of the HTC to support the new concepts, to improve the diagnosis for traumatic brain injury.
Collaborator Contribution Provides a range of laboratory and clinical research space including, dedicated in-and-outpatient accommodation, staffed by trained personnel and access to HTA approved tissue biorepository.
Impact Just commenced.
Start Year 2023
 
Description Partnership with Dstl 
Organisation Defence Science & Technology Laboratory (DSTL)
Country United Kingdom 
Sector Public 
PI Contribution We have cemented relationship with DSTL and the MoD, centered around the development of point-of-care devices that could be deployed at home or on the battlefield. Via close interaction and planned secondments at Porton Down and the technological advances being developed during this project will help accelerate the development of clinically relevant systems through.
Collaborator Contribution This has attracted an inward investment and co-funding for research and knowledge-exchange activities of total of £30,000 in cash and £250,000 in-kind, supporting research & innovation and technology prototyping. Close interaction and support through the MoD's IP and knowledge transfer teams.
Impact - A joint publication. This outcome made a profound impact on the research and led to public engagement and outreach participation including, at the 'Think Tank', Birmingham and played a central role in a successful Dstl funded grant (DSTLX-1000098511) which led to 2 additional (Dstl and ESPRC CDT co-funded) PhD studentships. - In-kind support for further funding application. - This strategic partnership with Dstl further provides an infrastructure for the 'pull-through' of the new technology being developed, playing a pivotal role in delivering a new portable and robust technology designed for use on-site by doctors, paramedic crews, ambulance trusts, sports organisations, which will be directly translatable to the military frontline and to the NHS.
Start Year 2021
 
Title TRAUMATIC BRAIN INJURY DETECTION 
Description Apparatus (1) for the non-invasive in-vivo determination of changes in tissue, e.g. the myelination, of the optic nerve (ON) in a biological subject, said apparatus (1) comprising: a laser source (10) for generating an excitation laser beam (b); an optical system including a fundus camera (11) operatively associated with the laser source (10) for use in obtaining a fundus image for illuminating the optic nerve (ON) of a subject with the excitation laser beam (b); a detector (13) operatively associated with the optical system and configured to detect a Raman spectrum from the optic nerve (ON) and/or surrounding cerebral spinal fluid; and a processor provided with a computer program for comparing the detected Raman spectrum to at least one reference spectrum, the reference spectrum may correspond to the myelination of the optic nerve in a normal, healthy subject, for determining the changes in the myelination of the optic nerve of the subject based on the detecting and comparing steps from the Raman spectrum. 
IP Reference WO2021053351 
Protection Patent application published
Year Protection Granted 2021
Licensed No
Impact This is currently in-progress with MoD / Dstl.
 
Description Contribution to widening participation and schools outreach for better understanding of the discipline 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Schools
Results and Impact The team has been actively given talks on research and science and careers for school pupils.
We have taken an active part in interactive events as part of STEM engagement activities at school demonstrations, assemblies, and career days.
Pupils on individual level and organizers reported great interest, increased TBI awareness and the overall activities encouraged the next generation to study science and Engineering.
Year(s) Of Engagement Activity 2021,2022
 
Description MacRobert Award Panel 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This panel discussion included former winners of the prestigious MacRobert Award for UK engineering innovation, looking at how we can create a hospitable environment for engineering and what some of the next revolutionary developments might be.
Year(s) Of Engagement Activity 2022
 
Description Plenary talk at the 2nd Global Summit on Brain Disorders and therapeutics 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Webinar hosted by Conference series LLC LTD.

Talk sparked a through discussion afterwards, laying the platform to creation of new linkages with clinicians.
Year(s) Of Engagement Activity 2022
 
Description Public Outreach and PPIE Group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Engaging with public is an essential element of our research activities, where public and patient perception are extremely important in gaining acceptance or enthusiasm for this new technology. Our team has a strong commitment to public and patient engagement, targeting a variety of audiences to give insights into my research, explaining its impact on society and increase awareness of neurological injuries. To date, we have organised and run (in-person and online) events to share the aims, progress, technical and clinical feasibility of research developments, working closely with PPIE, consisting of trauma patients and carers/family with lived experience of neurological trauma, who highlighted the need of new devices, such as these we are developing, with particular focus on rapid diagnosis to assist triage for the patient and the NHS benefits, particularly valuing the portability, enabling pre-hospital diagnosis without a scan.
Year(s) Of Engagement Activity 2021,2022
 
Description SPIE Optics and Photonics 2022, San Diego 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Plasmonics: Design, Materials, Fabrication, Characterization, and Applications XX, part of SPIE Nanoscience + Engineering, https://spie.org/OP103.

Audience reported interest in this subject. PDRA won third place poster prize.
Year(s) Of Engagement Activity 2022
 
Description The Academic Department of Military Surgery and Trauma (ADMST) and Defence Science and Technology Laboratory (Dstl) Inaugural Defence Surgical Research conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The Academic Department of Military Surgery and Trauma (ADMST) and Defence Science and Technology Laboratory (Dstl) Inaugural Defence Surgical Research conference - provided an important networking event and discussion about the technology being developed, creating further collaborative possibilities.
Year(s) Of Engagement Activity 2022