Scott Matthew R, Misko Albert, Liu Yang, Sverdlov Oleksandr
Department of Biostatistics, School of Public Health, Boston University, Boston, MA, USA.
Novartis Institutes for Biomedical Research, Cambridge, MA, USA.
Orphanet J Rare Dis. 2025 Jul 27;20(1):379. doi: 10.1186/s13023-025-03918-7.
SYNGAP1-related disorder (SRD) is a rare neurodevelopmental disorder caused by genetic variants. A major challenge is the characterization of SRD, which requires assessment of several outcomes. We considered natural history data from the Citizen database on 65 patients with SRD in eight data domains: demographics, genetics, growth parameters, standardized clinical scales, developmental skills, neurological examinations, hospitalizations, and seizures. Exploratory analysis tools such as visualizations, summary statistics, and non-parametric statistical modeling were utilized.
Age at SRD diagnosis (median [IQR] = 3 [2, 5] years; [min, max] = [1, 17] years) was similar by sex. No evidence of a high frequency allele change in SYNGAP1 was found, indicating no dominant variant in this patient population. Growth parameters of SRD children appeared normal in terms of height, weight, and head circumference. Developmental data were indicative of delayed development and language reversion. Standardized assessment data were largely sparse. Neurological exam data demonstrated ataxia and muscle tone issues. Hospitalization data highlighted substantial healthcare burden, largely due to seizures; absence, atonic, and myoclonic seizures were the most common types.
Citizen data provide important insights into the natural course of SRD. Our findings not only provide utility in clinical practice of SRD but also contribute valuable insights to guide the development of SRD clinical trials. Limitations to our analysis include sparsity of standardized clinical scales data, crude statistical methodology, and bias induced by patients with older ages of diagnoses.
SYNGAP1相关障碍(SRD)是一种由基因变异引起的罕见神经发育障碍。一个主要挑战是对SRD进行特征描述,这需要评估多个结果。我们考虑了公民数据库中65例SRD患者在八个数据领域的自然史数据:人口统计学、遗传学、生长参数、标准化临床量表、发育技能、神经学检查、住院情况和癫痫发作。使用了探索性分析工具,如可视化、汇总统计和非参数统计建模。
SRD诊断时的年龄(中位数[四分位间距]=3[2,5]岁;[最小值,最大值]=[1,17]岁)在性别上相似。未发现SYNGAP1高频等位基因变化的证据,表明该患者群体中没有显性变异。SRD儿童的生长参数在身高、体重和头围方面看起来正常。发育数据表明发育延迟和语言倒退。标准化评估数据大多较为稀疏。神经学检查数据显示存在共济失调和肌张力问题。住院数据突出了巨大的医疗负担,主要是由于癫痫发作;失神发作、失张力发作和肌阵挛发作是最常见的类型。
公民数据为SRD的自然病程提供了重要见解。我们的研究结果不仅在SRD的临床实践中有实用价值,还为指导SRD临床试验的开展提供了有价值的见解。我们分析的局限性包括标准化临床量表数据的稀疏性、粗略的统计方法以及诊断年龄较大的患者引起的偏差。