Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.
Department of Neurology, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
BMJ Open. 2024 Jan 29;14(1):e077799. doi: 10.1136/bmjopen-2023-077799.
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.
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.
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.
ChiCTR2100043886.
神经精神障碍是急性缺血性脑卒中的常见临床表现，但常被临床医生忽视。本研究旨在从解剖学和功能的角度，借助神经影像学方法，探讨缺血性脑卒中后神经精神障碍（NDIS）的可能病因和发病机制。
CONNECT 是一项关于神经影像学及其在 NDIS 中功能结果的前瞻性队列研究。我们计划招募至少 300 名首次发生中风的患者。本研究中涉及的神经心理障碍包括抑郁、焦虑障碍、头痛、淡漠、失眠、疲劳和认知障碍。使用已证明在评估上述症状方面有效的量表，NDIS 评估量表在基线时至少需要 2 小时。此外，所有患者都需要完成 2 年的随访，在此期间，在指数中风后 6 个月、3 个月、12 个月和 24 个月通过电话，以及 6 个月通过门诊访谈，重新评估 NDIS。我们研究的主要结果是 6 个月时 NDIS 的发生率。次要结果与 NDIS 的严重程度以及患者的功能康复有关。在基线和 6 个月随访时，使用包括静息态功能磁共振成像、弥散张量成像、T1 加权成像、T2 加权成像、弥散加权成像、动脉自旋标记、定量磁化率成像和液体衰减反转恢复成像在内的特定序列进行功能影像学评估。此外，我们从患者中收集血液学信息，通过组织学分析探索 NDIS 的潜在生物学和遗传标志物。
CONNECT 研究已获得中国科学技术大学第一附属医院伦理审查委员会的批准（2021-ky012），并将从所有参与者处获得书面知情同意书。结果将通过同行评议的期刊进行传播。
ChiCTR2100043886。
