Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Boston, Massachusetts.
Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.
Int J Neuropsychopharmacol. 2021 Apr 21;24(4):256-313. doi: 10.1093/ijnp/pyaa051.
Transcranial direct current stimulation has shown promising clinical results, leading to increased demand for an evidence-based review on its clinical effects.
We convened a team of transcranial direct current stimulation experts to conduct a systematic review of clinical trials with more than 1 session of stimulation testing: pain, Parkinson's disease motor function and cognition, stroke motor function and language, epilepsy, major depressive disorder, obsessive compulsive disorder, Tourette syndrome, schizophrenia, and drug addiction.
Experts were asked to conduct this systematic review according to the search methodology from PRISMA guidelines. Recommendations on efficacy were categorized into Levels A (definitely effective), B (probably effective), C (possibly effective), or no recommendation. We assessed risk of bias for all included studies to confirm whether results were driven by potentially biased studies.
Although most of the clinical trials have been designed as proof-of-concept trials, some of the indications analyzed in this review can be considered as definitely effective (Level A), such as depression, and probably effective (Level B), such as neuropathic pain, fibromyalgia, migraine, post-operative patient-controlled analgesia and pain, Parkinson's disease (motor and cognition), stroke (motor), epilepsy, schizophrenia, and alcohol addiction. Assessment of bias showed that most of the studies had low risk of biases, and sensitivity analysis for bias did not change these results. Effect sizes vary from 0.01 to 0.70 and were significant in about 8 conditions, with the largest effect size being in postoperative acute pain and smaller in stroke motor recovery (nonsignificant when combined with robotic therapy).
All recommendations listed here are based on current published PubMed-indexed data. Despite high levels of evidence in some conditions, it must be underscored that effect sizes and duration of effects are often limited; thus, real clinical impact needs to be further determined with different study designs.
经颅直流电刺激已显示出有前景的临床结果，这导致对其临床效果进行基于证据的综述的需求增加。
我们召集了一组经颅直流电刺激专家，对超过 1 个疗程刺激测试的临床试验进行系统综述：疼痛、帕金森病运动功能和认知、中风运动功能和语言、癫痫、重度抑郁症、强迫症、妥瑞氏综合征、精神分裂症和药物成瘾。
专家们被要求根据 PRISMA 指南的搜索方法进行这项系统综述。对疗效的建议分为 A 级（绝对有效）、B 级（可能有效）、C 级（可能有效）或无推荐。我们评估了所有纳入研究的偏倚风险，以确认结果是否由潜在有偏倚的研究驱动。
尽管大多数临床试验都设计为概念验证试验，但本综述分析的一些适应证可被认为是绝对有效（A级），如抑郁症，可能有效（B 级），如神经病理性疼痛、纤维肌痛、偏头痛、术后患者自控镇痛和疼痛、帕金森病（运动和认知）、中风（运动）、癫痫、精神分裂症和酒精成瘾。偏倚评估表明，大多数研究的偏倚风险较低，偏倚敏感性分析并未改变这些结果。效应大小从 0.01 到 0.70 不等，约有 8 种情况具有统计学意义，最大效应大小见于术后急性疼痛，中风运动恢复较小（与机器人治疗联合时无统计学意义）。
这里列出的所有建议都是基于当前发表的 PubMed 索引数据。尽管某些情况下的证据水平很高，但必须强调的是，效应大小和效果持续时间往往是有限的；因此，需要通过不同的研究设计进一步确定其实际临床影响。
