Conversion and neuro-inflammation disorder observational study (CANDO). Protocol of a feasibility study

Background: Conversion disorder (CD) or functional neurological disorder (FND) affects at least 764,000 people in the UK per year. As its origin is unknown and treatment has limited effects the condition forms a high individual and societal burden and clinically-unmet need. Research aiming to improve the outlook for people with this condition is urgently required. Exploration of the role of stress response and systemic low-grade inflammation (SLI) in CD/FND is warranted. The first step is to establish the feasibility of identifying, recruiting and assessing a clinical cohort of CD/FND patients for biomarkers of SLI, in addition to objective and subjective measures of stress and related factors. Methods: The settings are currently clinics and services within the Tees, Esk and Wear Valleys NHS Foundation Trust (TEWV). Phase 1 and phase 3 of our work are described in this paper, assessing the feasibility of assessing a cohort of CD/FND patients. Ethical approval has been granted for this study. The study will use observational measures including a blood sample for assessment of inflammation biomarkers; hair cortisol testing; self-report measures of stress, childhood trauma and health; targeted neurocognitive functioning and psychiatric examination. The findings will be used to inform future phases of our work. Discussion: Study outcomes will be knowledge about levels of SLI, psychological and cognitive symptoms in patients with CD/FND that is so far largely unknown. Knowledge regarding the feasibility of conducting a study in this population will also be gained. This will enable a comprehensive testing and evaluation of the proposed processes of recruitment, retention and data collection. This is hoped to lay the groundwork for future work leading to the development of novel treatments for CD/FND patients. Registration: researchregistry.com researchregistry5289