ICONS (Imaging, Cognition and Neuropsychological Outcomes after Subarachnoid haemorrhage): protocol of a longitudinal, prospective, cohort study to investigate recovery (Preprint)

BACKGROUND A subarachnoid haemorrhage (SAH) is a severe bleeding in the subarachnoid space that is often caused by the rupture of an aneurysm. Patients who survive SAH have a high risk for complications and negative long-term outcome. OBJECTIVE The aim of the Imaging, Cognition and Outcome of Neuropsychological functioning after Subarachnoid haemorrhage (ICONS) study is to investigate the effects of cognitive, emotional, and behavioural deficits as well as brain damage in the subacute stage, on long-term recovery after SAH. Recovery is defined as functioning at societal participation level, with a focus on both resuming and maintaining work, leisure activities, and social relationships on the long-term. METHODS The ICONS study is an observational, prospective, single-centre cohort study. A total number of 150 SAH patients will be recruited from the University Medical Centre Groningen. Inclusion criteria consist of an aneurysmal SAH (aSAH) or angiographically negative SAH (anSAH) diagnosis, sufficient mastery of the Dutch language and age older than 18 years. Patients will undergo neuropsychological assessment and magnetic resonance imaging (MRI) at 6 months after SAH. Furthermore, patients are asked to fill in questionnaires on multiple psychosocial measures and undergo a structured interview at 6 months, 1-year, and 2-years after SAH. The primary outcome measure of the ICONS study is societal participation 1-year post-SAH, measured with the Dutch version of the Impact on Participation and Autonomy questionnaire. RESULTS The study is already ongoing for 2 years, and thus far, 56 patients and 62 healthy controls have been included. First results are expected early 2023. CONCLUSIONS This study is the first to collect and combine data in a variety of domains (cognition, emotion and behaviour, and brain damage), which allows for a broad investigation of recovery after SAH. New, and advanced neuro-imaging methods, that are considered more sensitive measures as compared to conventional MRI, are applied to measure brain damage. CLINICALTRIAL Netherlands Trial Register NL7803, June 17, 2019