Neuroimaging of neuropsychological disturbances following ischaemic stroke (CONNECT): a prospective cohort study protocol.

INTRODUCTION

Neuropsychiatric distubance is a common clinical manifestation in acute ischemic stroke. However, it is frequently overlooked by clinicians. This study aimed to explore the possible aetiology and pathogenesis of neuropsychiatric disturbances following ischaemic stroke (NDIS) from an anatomical and functional perspective with the help of neuroimaging methods.

METHOD AND ANALYSIS

CONNECT is a prospective cohort study of neuroimaging and its functional outcome in NDIS. We aim to enrol a minimum of 300 individuals with first-ever stroke. The neuropsychological disturbances involved in this study include depression, anxiety disorder, headache, apathy, insomnia, fatigue and cognitive impairment. Using scales that have been shown to be effective in assessing the above symptoms, the NDIS evaluation battery requires at least 2 hours at baseline. Moreover, all patients will be required to complete 2 years of follow-up, during which the NDIS will be re-evaluated at 3 months, 12 months and 24 months by telephone and 6 months by outpatient interview after the index stroke. The primary outcome of our study is the incidence of NDIS at the 6-month mark. Secondary outcomes are related to the severity of NDIS as well as functional rehabilitation of patients. Functional imaging evaluation will be performed at baseline and 6-month follow-up using specific sequences including resting-state functional MRI, diffusion tensor imaging, T1-weighted imaging, T2-weighted imaging, diffusion-weighted imaging, arterial spin labelling, quantitative susceptibility mapping and fluid-attenuated inversion recovery imaging. In addition, we collect haematological information from patients to explore potential biological and genetic markers of NDIS through histological analysis.

ETHICS AND DISSEMINATION

The CONNECT Study was approved by the Ethics Review Committee of the First Hospital of the University of Science and Technology of China (2021-ky012) and written informed consent will be obtained from all participants. Results will be disseminated via a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ChiCTR2100043886.