BACKGROUND Deep brain stimulation (DBS) is a surgical neuromodulation procedure with a historically wide range of possible therapeutic indications, including movement disorders, neuropsychiatric conditions, and cognitive disorders. Ongoing research in this field is critical to gain further insights into the mechanisms of DBS, to discover novel brain targets for new and existing indications, and to refine targeting and post-operative programming techniques for the optimization of therapeutic outcomes. OBJECTIVE To update on the state of DBS-related clinical human research by cataloging and summarizing clinical trials that have been completed or are currently ongoing in this field worldwide. METHODS A search was conducted for clinical trials pertaining to DBS, currently listed on the ClinicalTrials.gov database. Trials were analyzed to generate a detailed overview of ongoing DBS-related research. Specifically, trials were categorized by trial start date, study completion status, clinical phase, projected subject enrollment, disorder, brain target, country of origin, device manufacturer, funding source, and study topic. RESULTS In total, 384 relevant clinical trials were identified. The trials spanned 28 different disorders across 26 distinct brain targets, with almost 40% of trials being for conditions other than movement disorders. The majority of DBS trials have been US-based (41.9% of studies) but many countries are becoming increasingly active. The ratio of investigator-sponsored to industry-sponsored trials was 3:1. Emphasizing the need to better understand the mechanism of action of DBS, one-third of the studies predominantly focus on imaging or electrophysiological changes associated with DBS. CONCLUSIONS This overview of current DBS-related clinical trials provides insight into the status of DBS research and what we can anticipate in the future concerning new brain targets, indications, techniques, and developing a better understanding of the mechanisms of action of DBS.

中文翻译：

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深部脑刺激的临床试验：现状

背景深部脑刺激（DBS）是一种外科神经调节程序，具有历史上广泛的可能的治疗适应症，包括运动障碍、神经精神疾病和认知障碍。该领域正在进行的研究对于进一步了解 DBS 的机制、发现新的和现有适应症的新大脑靶点以及改进靶向和术后编程技术以优化治疗结果至关重要。目的 通过编目和总结全球该领域已完成或目前正在进行的临床试验，更新 DBS 相关临床人体研究的状态。方法 对目前在 ClinicalTrials.gov 数据库中列出的 DBS 相关临床试验进行了搜索。分析试验以生成正在进行的 DBS 相关研究的详细概述。具体而言，试验按试验开始日期、研究完成状态、临床阶段、预计受试者入组、障碍、大脑目标、原产国、设备制造商、资金来源和研究主题进行分类。结果 总共确定了 384 项相关的临床试验。这些试验涵盖了 26 个不同大脑目标的 28 种不同疾病，其中近 40% 的试验针对运动障碍以外的疾病。大多数 DBS​​ 试验都在美国进行（占研究的 41.9%），但许多国家正变得越来越活跃。研究者发起的试验与行业发起的试验的比率为 3:1。强调需要更好地了解 DBS 的作用机制，三分之一的研究主要关注与 DBS 相关的成像或电生理变化。结论 目前 DBS 相关临床试验的概述提供了对 DBS 研究现状的洞察，以及我们在未来关于新的大脑目标、适应症、技术和更好地理解 DBS 作用机制的预期。