Title: Personal Lithium Blood Level Analyser for patients with Bipolar Mood Disorder
Funder: Department of Health (England)

Abstract: The project will comprise of four Phases. Phase I will involve controlled in-vitro studies to confirm the optical and electrical impedance parameters of lithium in blood and saline and the integration of the system. Firstly, both optical and impedance spectroscopy will be evaluated independently on solutions of lithium. This phase is necessary to independently identify the parameters required for accurate lithium detection and to optimise each sub-system accordingly. Following this, the system will be integrated: both the NIRS and EIS stages will be combined in a single operating unit. This stage will include cross-compliance optimisation to ensure that both sub-systems do not interfere and to ensure that they are appropriately multiplexed. The system will then be validated on a tissue phantom, to take into account the contributions of the tissue layer to the overall measurement. Finally, software algorithms will be incorporated so that the signals can be analysed and an “optimum” calculation of lithium is provided. During this phase, Service User involvement will be sought to highlight pivotal design issues and considerations. In Phase II , the technology from Phase I will be miniaturised to provide a user-friendly, portable device that can be used by bipolar patients. Following Service User input, a best site for measurement (ear, finger, etc) will be identified and a miniaturised sensor will be developed. Its interface to the patient will be realised through a disposable attachment. This attachment will be adhesive, to ensure good contact with the skin, and will contain the electrodes required for impedance measurements. A sufficient amount of these disposable attachments will be fabricated to facilitate the clinical investigations in Phase III. The instrumentation/technology unit will be miniaturised through intelligent design that will make maximum use of the devices involved, reduce complexity and minimise power in order to provide a portable, battery operated unit. Following Service user input on the best mode of displaying the results to the user, software algorithms will be incorporated on a microcontroller and meaningful results displayed on a LCD screen. Aspects of aesthetics and functionality will also be considered. In Phase III Research Ethics and MHRA applications will be made. Service User involvement will be requested in aiding the design of the clinical investigations. The research ethics application will request permission to perform measurements in 50 patients currently on lithium treatment. Patients will be enrolled following informed, written consent. The researcher will attend a GP surgery where bipolar patients are due to have a routine blood sample withdrawn for laboratory tests. The protocol will involve taking a measurement with the non-invasive blood lithium level sensor on the patientss before the withdrawal of blood. The blood sample will be sent to the laboratory, and the results of the test from the enrolled patients will be sent to the research team as well as the GP. In Phase IV the acquired data will be analysed and trends in the measured data will be correlated with the results of the laboratory tests. The findings of the pilot will inform a power calculation for further experiments with enough subjects/ blood samples in order to examine the sensitivity of the device. All results will be disseminated at peer review journals, national and international conferences and at a Service User discussion group. During the Service User group discussion, other possible avenues for dissemination will be discussed. Throughout all Phases of the Project the corresponding technology transfer offices of both City University and Barts and The London Medical School, Queen Mary University will be engaging in detailed market research analysis, securement of all IP, and actions to encourage commercial interest in the project.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: MENTAL HEALTH