Neurology Section, School of Medicine and Surgery, Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy.
Neurology Ward, San Gerardo Hospital, Monza, Italy.
Neurol Sci. 2023 Oct;44(10):3395-3427. doi: 10.1007/s10072-023-06821-w. Epub 2023 May 19.
Dementia affects more than 55 million people worldwide. Several technologies have been developed to slow cognitive decline: deep brain stimulation (DBS) of network targets in Alzheimer's disease (AD) and dementia with Lewy bodies (DLB) have been recently investigated.
This study aimed to review the characteristics of the populations, protocols, and outcomes of patients with dementia enrolled in clinical trials investigating the feasibility and efficacy of DBS.
A systematic search of all registered RCTs was performed on Clinicaltrials.gov and EudraCT, while a systematic literature review was conducted on PubMed, Scopus, Cochrane, and APA PsycInfo to identify published trials.
The literature search yielded 2122 records, and the clinical trial search 15 records. Overall, 17 studies were included. Two of 17 studies were open-label studies reporting no NCT/EUCT code and were analysed separately. Of 12 studies investigating the role of DBS in AD, we included 5 published RCTs, 2 unregistered open-label (OL) studies, 3 recruiting studies, and 2 unpublished trials with no evidence of completion. The overall risk of bias was assessed as moderate-high. Our review showed significant heterogeneity in the recruited populations regarding age, disease severity, informed consent availability, inclusion, and exclusion criteria. Notably, the standard mean of overall severe adverse events was moderately high (SAEs: 9.10 ± 7.10%).
The population investigated is small and heterogeneous, published results from clinical trials are under-represented, severe adverse events not negligible, and cognitive outcomes uncertain. Overall, the validity of these studies requires confirmation based on forthcoming higher-quality clinical trials.
全球有超过 5500 万人患有痴呆症。为了减缓认知能力下降，已经开发出几种技术：最近研究了阿尔茨海默病（AD）和路易体痴呆（DLB）网络靶点的深部脑刺激（DBS）。
本研究旨在综述痴呆症患者参加临床试验的特征、方案和结局，这些临床试验旨在评估 DBS 的可行性和疗效。
在 Clinicaltrials.gov 和 EudraCT 上对所有已注册的 RCT 进行了系统搜索，同时在 PubMed、Scopus、Cochrane 和 APA PsycInfo 上进行了系统文献综述，以确定已发表的试验。
文献搜索得到 2122 条记录，临床试验搜索得到 15 条记录。共有 17 项研究纳入。17 项研究中的 2 项为未报告 NCT/EUCT 编码的开放标签研究，单独进行了分析。在 12 项关于 DBS 在 AD 中作用的研究中，我们纳入了 5 项已发表的 RCT、2 项未注册的开放标签（OL）研究、3 项招募研究和 2 项未发表的试验，没有完成的证据。总体偏倚风险评估为中度偏高。我们的综述显示，在年龄、疾病严重程度、知情同意可用性、纳入和排除标准方面，招募的人群存在显著的异质性。值得注意的是，总体严重不良事件的标准均值为中度偏高（SAEs：9.10±7.10%）。
所研究的人群规模较小且异质性较大，临床试验的发表结果代表性不足，严重不良事件不容忽视，认知结果不确定。总体而言，这些研究的有效性需要基于即将进行的高质量临床试验来确认。
