BRAIN CONNECTIONS: ADD-ON STUDY OF SERIAL BRAIN MRIS EVERY SIX MONTHS

大脑连接：每六个月进行一次连续脑 MRI 附加研究

• 批准号: 7604629
• 负责人: MICHELLE A PETRI
• 金额: $ 0.08万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604629
• 关键词: Affect; Anatomy; Annual Reports; Antiphospholipid Antibodies; Anxiety; Atrophic; Attention; Biological Assay; Blinded; Brain; Brain imaging; Characteristics; Chorea; Clinical; Cognitive; Cohort Studies; Complement; Computer Retrieval of Information on Scientific Projects Database; Computers; Consensus; Dementia; Deoxyglucose; Diagnostic Procedure; Disease; Enrollment; Foxes; Frequencies; Funding; Grant; Image; Image Analysis; Imaging Techniques; Institution; Lesion; Literature; Magnetic Resonance Imaging; Measures; Memory; Mental Depression; Monitor; Morbidity - disease rate; Neurologic; Neurologist; Neuropsychological Tests; Newly Diagnosed; Numbers; Organ; Outcome; Outcome Measure; Participant; Patients; Peripheral Nervous System Diseases; Pilot Projects; Population Study; Positron-Emission Tomography; Prednisone; Prevalence; Process; Protons; Quality of life; Range; Rate; Reaction Time; Reader; Reading; Research; Research Design; Research Personnel; Resources; Sampling; Scanning; Seizures; Sensitivity and Specificity; Serological; Source; Stroke; Syndrome; Systemic Lupus Erythematosus; Techniques; Testing; Texas; Time; United States National Institutes of Health; Universities; Weight; abstracting; cerebral atrophy; cognitive function; density; follow-up; indexing; male; prospective; tool

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Brain CONECTIONS: Add-on Study of Serial Brain MRIs Every Six Months ABSTRACT (Annual Report 12/01/2004 - 11/30/2005) Background: Neuropsychaitric SLE (NPSLE) occurs in 50-75% of SLE patients, depending on the sampling procedures and diagnostic criteria used and is a major source of morbidity and decreased quality of life. If cognitive function is carefully evaluated with sensitive neuropsychological testing, an even larger number of patients may have SLE-related neurologic involvement. SLE-related neurologic involvement encompasses a wide spectrum of overt neurologic and psychiatric features ranging from strokes, seizures, peripheral neuropathy, chorea, dementia, anxiety, and depression to more subtle cognitive abnormalities such as attention, memory, and visio-spatial abnormalities. Brain imaging is a powerful tool to noninvasively identify and differentiate the pathophysiological mechanisms responsible for NPSLE syndromes. Alone or in combination, anatomic Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) with 2-[18F]fluoro-2-deoxy-D-glucose (FDG) are the most widely used brain imaging techniques to study patients with NPSLE syndromes. Inconsistencies in the literature regarding the sensitivity and specificity of these techniques likely reflect inclusion of SLE patients with heterogeneous clinical presentations caused by different underlying pathophysiological mechanisms. Brain CONECTIONS is an NIH-funded ongoing, prospective, observational multi-center cohort study of cognitive function in newly-diagnosed patients with SLE. Brain MRI and PET are done at baseline, at year 3, and if there is an important decline in cognitive functioning on the ANAM, an automated battery of tests. Rationale: Analyses of 31 baseline brain MRI scans done to date among the participants of Brain CONECTIONS study found a surprising frequency of brain atrophy: 26% of patients had mild brain atrophy and 26% had moderate brain atrophy. This recent imaging findings from the Brain CONECTIONS study suggest the following: 1) newly diagnosed SLE patients have a high frequency of anatomic brain MRI abnormalities, 2) MRI abnormalities are associated with decreased sustained attention and reaction time and higher disease activity at study entry. This suggests that both functional and structural damage to the brain is evident early in the disease process and underscores the critical need to understand the underlying mechanism of brain involvement in SLE. "Brain CONECTIONS: Add-on Study of Serial Brain MRIs Every Six Months" allows brain MRIs to be done every 6 months, to find associates and predictors of brain atrophy irrespective of major change in cognitive functioning. Study questions and Specific aim: One: Determine the frequency of and potential reversibility or worsening of brain atrophy at baseline AND at 6 monthly follow-up. Two: Determine if atrophy is associated with clinical activity, as measured by clinical disease indices or serologic assays including low complements, high anti-DNA, and antiphospholipid antibodies. Three: Determine whether SLE treatment (determined by activity in other organs) affects brain atrophy: does prednisone worsens brain atrophy? Study Design: This is a pilot study designed to ascertain whether brain atrophy in SLE patients is progressive, stable, or reversible. In addition, we will explore demographic and clinical characteristics that may be associated with or predictive of brain atrophy. Neuro Image Acquisition Anatomic MRI image scanning are done every six months for the time that the patient has remaining in the Brain CONECTIONS study. As the prevalence of atrophy was so high at baseline, we feel it is important to follow subjects at six month intervals to determine if the atrophy is reversible and if it is associated with clinical activity. Anatomical MRI scans will include a T1- weighted, a T2- weighted, a proton density-weighted, and a 3D Gradient Recalled Acquisitions. Image reading will be performed on images displayed on screen monitors. All MRI images will be in DICOM 3 format. Controls are always included, in a blinded fashion, in the reading sessions at the University of Texas, San Antonio. Male controls are available. Dr. Brey and Dr. Fox (neurologist and neuroradiologist) are the principal readers. For patients, we record psychiatric illness. For qualitative analyses, images obtained from the brain MRI scans will be displayed on a screen using computer projection in a blinded fashion. Images will be projected in random order and will be read by consensus by the neurologists at the University of Texas, San Antonio. The rating for the MRI are: 0 = Normal, 1 = Mild atrophy, 2 = Moderate atrophy, any focal lesion, 3 = Severe atrophy, >5 focal lesions. Study Population: All Brain CONECTIONS patients entered at Hopkins are eligible for this add-on study. Outcome Measures: The primary outcome is the rating scale of 0, 1 (Mild), 2 (Moderate), and 3 (Severe). Current enrollment (12/01/2004 - 11/30/2005): 31 patients already completed the 1st Brain MRI of the add-on study of which 18 patients also completed the 6 month follow-up MRI.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 脑连接：每六个月进行一次系列脑MRI的附加研究 摘要（2004年1月12日至2005年11月30日年度报告） 背景资料： 神经精神性SLE（NPSLE）发生在50-75%的SLE患者中，这取决于所使用的采样程序和诊断标准，并且是发病率和生活质量下降的主要来源。如果用敏感的神经心理学测试仔细评估认知功能，更多的患者可能有SLE相关的神经系统受累。SLE相关的神经系统受累包括广泛的明显神经系统和精神病学特征，范围从中风、癫痫发作、周围神经病变、舞蹈病、痴呆、焦虑和抑郁到更微妙的认知异常，如注意力、记忆力和空间障碍。 脑成像是一个强有力的工具，非侵入性识别和区分的病理生理机制负责NPSLE综合征。单独或联合使用，解剖磁共振成像（MRI）和正电子发射断层扫描（PET）与2-[18 F]氟-2-脱氧-D-葡萄糖（FDG）是研究NPSLE综合征患者最广泛使用的脑成像技术。文献中关于这些技术的敏感性和特异性的研究可能反映了纳入了由不同基础病理生理机制引起的异质性临床表现的SLE患者。 Brain CONECTIONS是一项由NIH资助的正在进行的、前瞻性、观察性多中心队列研究，旨在评估新诊断的SLE患者的认知功能。大脑MRI和PET在基线时进行，在第3年，如果在ANAM上认知功能出现重要下降，则进行自动化测试。 基本原理： 对迄今为止在脑连接研究参与者中进行的31次基线脑MRI扫描的分析发现了令人惊讶的脑萎缩频率：26%的患者患有轻度脑萎缩，26%患有中度脑萎缩。 脑连接研究的最新影像学结果表明：1）新诊断的SLE患者具有高频率的解剖学脑MRI异常，2）MRI异常与持续注意力和反应时间减少以及研究入组时疾病活动性增加相关。这表明，在疾病过程的早期，大脑的功能和结构损伤是明显的，并强调了理解SLE大脑参与的潜在机制的迫切需要。 “脑连接：每六个月进行一次系列脑MRI的附加研究”允许每六个月进行一次脑MRI，以发现脑萎缩的相关因素和预测因素，而不管认知功能是否发生重大变化。 研究问题和具体目标： 一：确定基线和6个月随访时脑萎缩的频率和潜在可逆性或恶化。 二：通过临床疾病指数或血清学检测（包括低补体、高抗DNA和抗磷脂抗体）确定萎缩是否与临床活动相关。 第三：确定SLE治疗（由其他器官的活动决定）是否影响脑萎缩：强的松是否能抑制脑萎缩？ 研究设计： 这是一项初步研究，旨在确定SLE患者的脑萎缩是进行性的、稳定的还是可逆的。 此外，我们将探讨可能与脑萎缩相关或预测脑萎缩的人口统计学和临床特征。 神经图像采集 在患者继续参与脑连接研究期间，每6个月进行一次解剖MRI图像扫描。由于基线时萎缩的患病率如此之高，我们认为以6个月的间隔随访受试者以确定萎缩是否可逆以及是否与临床活动相关非常重要。 解剖MRI扫描将包括T1加权、T2加权、质子密度加权和3D梯度回忆采集。将对屏幕监视器上显示的图像执行图像阅读。 所有MRI图像将采用DICOM 3格式。 在德克萨斯大学圣安东尼奥的阅读课程中，始终以盲态方式纳入对照。男性控制可用。Brey博士和Fox博士（神经科医生和神经放射科医生）是主要的读者。对于病人，我们记录精神疾病。 对于定性分析，将使用计算机投影以设盲方式在屏幕上显示从脑部MRI扫描获得的图像。图像将以随机顺序投射，并由德克萨斯大学圣安东尼奥的神经学家一致阅读。MRI的评级为：0 =正常，1 =轻度萎缩，2 =中度萎缩，任何局灶性病变，3 =重度萎缩，>5个局灶性病变。 研究人群： 所有进入霍普金斯的脑连接患者都有资格参加这项附加研究。 结果测量： 主要结局是0、1（轻度）、2（中度）和3（重度）的评定量表。 当前入组（2004年12月1日-2005年11月30日）： 31例患者已经完成了附加研究的首次脑部MRI，其中18例患者还完成了6个月随访MRI。