Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 22, 2022
Open Peer Review Period: Mar 22, 2022 - May 17, 2022
Date Accepted: Sep 8, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
ICONS (Imaging, Cognition and Neuropsychological Outcomes after Subarachnoid haemorrhage): protocol of a longitudinal, prospective, cohort study to investigate recovery
ABSTRACT
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. Clinical Trial: Netherlands Trial Register NL7803, June 17, 2019
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