Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, 2100, Copenhagen, Denmark.
Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, Odense C, 5000, Odense, Denmark.
Syst Rev. 2022 Oct 13;11(1):218. doi: 10.1186/s13643-022-02095-z.
Deep brain stimulation has been used since the 1980s for neurological disorders and the USA and Europe have now approved it for Parkinson's disease, essential tremor, dystonia, and epilepsy. Previous reviews have assessed the effects of deep brain stimulation on different neurological disorders. These reviews all had methodological limitations.
This is a protocol for a systematic review based on searches of major medical databases (e.g. MEDLINE, EMBASE, CENTRAL) and clinical trial registries. Two review authors will independently extract data and conduct risk of bias assessment. We will include published and unpublished randomised clinical trial comparing deep brain stimulation versus no intervention, usual care, sham stimulation, medical treatment, or resective surgery for Parkinson's disease, essential tremor, dystonia, or epilepsy. The effects of deep brain stimulation will be analysed separately for each of the different diagnoses. Primary outcomes will be all-cause mortality, disease-specific symptoms, and serious adverse events. Secondary outcomes will be quality of life, depressive symptoms, executive functioning, level of functioning, and non-serious adverse events. Data will be analysed using fixed-effect and random-effects meta-analyses and Trial Sequential Analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool-version 2, an eight-step procedure to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
Deep brain stimulation is increasingly being used for different neurological diseases, and the effects are unclear based on previous evidence. There is a need for a comprehensive systematic review of the current evidence. This review will provide the necessary background for weighing the benefits against the harms when assessing deep brain stimulation as intervention for individual neurological disorders.
PROSPERO 306,556.
自 20 世纪 80 年代以来，深部脑刺激已被用于治疗神经疾病，美国和欧洲现已批准其用于治疗帕金森病、原发性震颤、肌张力障碍和癫痫。先前的综述评估了深部脑刺激对不同神经疾病的影响。这些综述都存在方法学上的局限性。
这是一项基于对主要医学数据库（如 MEDLINE、EMBASE、CENTRAL）和临床试验注册中心进行检索的系统综述方案。两名综述作者将独立提取数据并进行偏倚风险评估。我们将纳入比较深部脑刺激与无干预、常规护理、假刺激、药物治疗或切除术治疗帕金森病、原发性震颤、肌张力障碍或癫痫的已发表和未发表的随机临床试验。深部脑刺激的效果将根据不同的诊断分别进行分析。主要结局将是全因死亡率、疾病特异性症状和严重不良事件。次要结局将是生活质量、抑郁症状、执行功能、功能水平和非严重不良事件。数据将使用固定效应和随机效应荟萃分析以及试验序贯分析进行分析。偏倚风险将使用 Cochrane 偏倚风险工具版本 2 进行评估，这是一个评估是否跨越临床意义阈值的八步程序，证据的确定性将通过推荐评估、制定和评估（GRADE）进行评估。
深部脑刺激越来越多地用于治疗不同的神经疾病，但基于先前的证据，其效果尚不清楚。需要对当前证据进行全面的系统综述。当评估深部脑刺激作为治疗个别神经疾病的干预措施时，本综述将为权衡利弊提供必要的背景。
PROSPERO 306,556。
