沉默期神经系统疾病多学科生活方式干预(MINDS)研究:多组学随机对照试验方案。

Q2 Medicine
Sara Taylor, Seerat Sachdeva, Sandra Darling, Kayela Arrotta, Lisa Gallagher, Alexis Supan, Gabrielle Shipta, Jim Perko, Judi Bar, Joe James, Iris Petschek, Anthony Lioi, Suman Kundu, Lisa Ellison, Lynn M Bekris, Belinda Willard, Naseer Sangwan, Ignacio Mata, Hubert Fernandez, Irene Katzan, Devon Conway, Jagan Pillai, James Leverenz, Robyn M Busch, Darlene Floden, Robert Saper, John Barnard, Andre Machado, Imad Najm, Vineet Punia
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引用次数: 0

摘要

导言:鉴于神经系统疾病的发病率和惊人的费用,我们迫切需要有效的早期检测和干预工具。新出现的证据表明,多学科生活方式干预(MLI)可降低神经系统疾病的风险和病情发展。本方案的目标是:(1) 检验多学科生活方式干预对神经系统疾病进展的影响;(2) 确定神经系统疾病早期阶段的多组学生物标志物以及多学科生活方式干预对这些生物标志物的影响:我们提出了针对静默期神经系统疾病的多学科生活方式干预(MINDS)方案,这是一项针对神经系统健康的老年人(≥ 50 岁)的多学科生活方式干预随机对照试验,这些老年人患常见神经系统疾病(中风、癫痫、帕金森病或阿尔茨海默病及相关痴呆症)的风险较高。参与者将被随机分配到干预组(100 人)或对照组(100 人)。干预组将接受为期 3 个月每周 2 小时的饮食教育、瑜伽、音乐疗法和认知技能培训。在为期 12 个月的时间里,将定期对参与者的神经系统健康状况和参与相关生活方式的情况进行评估。将在基线期、入组后 3 个月和 12 个月收集神经影像和多组学分析样本。主要结果将是使他们有资格参加研究的神经系统疾病风险的进展迹象或疾病的临床诊断。次要和探索性结果将基于自我健康报告和多组数据。数据分析将包括组间分析和组内纵向分析:MINDS方案和试验旨在阐明MLI对老年人神经系统疾病风险或诊断进展的影响,并确定可用于确认MLI疗效的生物标志物。根据生物标志物数据验证MLI对神经系统疾病进展的影响,可以在神经系统疾病的早期阶段识别出最有可能从这种疗法中获益的个体:该试验已在美国国立卫生研究院(NIH)ClinicalTrials.gov(NCT05984056)网站注册。注册日期为 2023 年 8 月 2 日。该试验已获得克利夫兰诊所内部审查委员会的全面批准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Multidisciplinary lifestyle interventions for neurological disorders during the Silent phase (MINDS) study: a multi-omics randomized controlled trial protocol.

Introduction: Given the prevalence and staggering cost of neurological disorders, there is dire need for effective early detection and intervention tools. Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders. The objectives of this protocol are (1) to test the impact of MLI on the progression of neurological disorders and (2) to identify multi-omic biomarkers for early stages of neurological disease and the impact of MLIs on these biomarkers.

Methods and analysis: We present the Multidisciplinary lifestyle Interventions for Neurological Disorders during the Silent phase (MINDS) protocol, a randomized controlled trial of MLI in neurologically healthy older adults (≥ 50 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson's Disease, or Alzheimer's disease and related dementias. Participants will be randomly assigned to intervention (n = 100) or control (n = 100) groups. The intervention group will receive 3 months of weekly 2-hour sessions on diet education, yoga, music therapy, and cognitive skills training. The participants' neurological health and engagement in relevant lifestyle practices will be assessed at regular intervals for 12 months. Neuroimaging and samples for multi-omic analyses will be collected at baseline, and at 3 months and 12 months after enrollment. Primary outcomes will be signs of progression of the neurological disorder risk that qualified them for study enrollment or a clinical diagnosis of the disorder. Secondary and exploratory outcomes will be based on self-reported health and multi-omic data. Data analysis will include between-group and longitudinal within-group analyses.

Perspectives: The MINDS protocol and trial aims to clarify the impact of MLI on the progression of neurological disorder risk or diagnosis in older adults and to identify biomarkers that can be used to confirm MLI efficacy. The ability to validate the impact of MLI on neurological disorder progression based on biomarker data allows the identification of individuals most likely to benefit from such therapies in the early stages of neurological disease.

Trial registration: The trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov (NCT05984056) site. It was registered on August 2nd, 2023. The trial has full approval of the Cleveland Clinic Internal Review Board.

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