Importance Transcranial direct current stimulation (tDCS) may improve symptoms of inattention in adults with attention-deficit/hyperactivity disorder (ADHD). However, previous trials are characterized by small sample sizes, heterogeneous methodologies, and short treatment periods using clinic-based tDCS. Objective To determine the efficacy and safety of home-based tDCS in treating inattention symptoms in adult patients with ADHD. Design, Setting, and Participants Randomized, double-blind, parallel, sham-controlled clinical trial (tDCS for the Treatment of Inattention Symptoms in Adult Patients With ADHD [TUNED]), conducted from July 2019 through July 2021 in a single-center outpatient academic setting. Of 277 potential participants screened by phone, 150 were assessed for eligibility on site, and 64 were included. Participants were adults with ADHD, inattentive or combined subtype. Exclusion criteria included current stimulant drug treatment, current moderate to severe symptoms of depression or anxiety, diagnosis of bipolar disorder with a manic or depressive episode in the last year, diagnosis of schizophrenia or another psychotic disorder, and diagnosis of autism spectrum disorder; 55 of participants completed follow-up after 4 weeks. Interventions Thirty-minute daily sessions of home-based tDCS for 4 weeks, 2 mA anodal-right and cathodal-left prefrontal stimulation with 35-cm2 carbon electrodes. Main Outcomes and Measures Inattentive scores in the clinician-administered version of the Adult ADHD Self-report Scale version 1.1 (CASRS-I). Results Included in this trial were 64 participants with ADHD (31 [48%] inattentive presentation and 33 [52%] combined presentation), with a mean (SD) age of 38.3 (9.6) years. Thirty participants (47%) were women and 34 (53%) were men. Fifty-five finished the trial. At week 4, the mean (SD) inattention score, as measured with CASRS-I, was 18.88 (5.79) in the active tDCS group and 23.63 (3.97) in the sham tDCS group. Linear mixed-effects models revealed a statistically significant treatment by time interaction for CASRS-I (βinteraction = -3.18; 95% CI, -4.60 to -1.75; P < .001), showing decreased symptoms of inattention in the active tDCS group over the 3 assessments compared to the sham tDCS group. Mild adverse events were more frequent in the active tDCS group, particularly skin redness, headache, and scalp burn. Conclusions and Relevance In this randomized clinical trial, daily treatment with a home-based tDCS device over 4 weeks improved attention in adult patients with ADHD who were not taking stimulant medication. Home-based tDCS could be a nonpharmacological alternative for patients with ADHD. Trial Registration ClinicalTrials.gov Identifier: NCT04003740.

中文翻译：

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经颅直流电刺激与假手术治疗成人注意力缺陷/多动症注意力不集中的比较：TUNED 随机临床试验。

重要性 经颅直流电刺激 (tDCS) 可以改善患有注意力缺陷/多动障碍 (ADHD) 的成人注意力不集中的症状。然而，之前的试验具有样本量小、方法异质性以及使用基于临床的 tDCS 治疗周期短的特点。目的 确定家庭 tDCS 治疗成年 ADHD 患者注意力不集中症状的有效性和安全性。设计、设置和参与者 随机、双盲、平行、假对照临床试验（用于治疗成人 ADHD 患者注意力不集中症状的 tDCS [TUNED]），于 2019 年 7 月至 2021 年 7 月在单中心门诊患者中进行学术环境。通过电话筛选了 277 名潜在参与者，其中 150 人接受了现场资格评估，最终纳入 64 人。参与者是患有多动症、注意力不集中或混合亚型的成年人。排除标准包括当前的兴奋剂药物治疗、当前的中度至重度抑郁或焦虑症状、诊断为去年有躁狂或抑郁发作的双相情感障碍、诊断为精神分裂症或其他精神障碍，以及诊断为自闭症谱系障碍；55 名参与者在 4 周后完成了随访。干预措施 每天 30 分钟的家庭 tDCS，持续 4 周，使用 35 cm2 碳电极进行 2 mA 阳极右前额叶刺激和阴极左前额叶刺激。主要结果和措施 临床医生管理的成人多动症自我报告量表 1.1 版 (CASRS-I) 中的注意力不集中评分。结果 本试验包括 64 名 ADHD 参与者（31 名 [48%] 表现为注意力不集中，33 名 [52%] 为合并表现为），平均 (SD) 年龄为 38.3 (9.6) 岁。30 名参与者 (47%) 为女性，34 名参与者 (53%) 为男性。五十五完成审判。第 4 周时，使用 CASRS-I 测量的平均注意力不集中评分（SD）在主动 tDCS 组中为 18.88 (5.79)，在假 tDCS 组中为 23.63 (3.97)。线性混合效应模型显示，CASRS-I 的时间交互作用具有统计学显着性（β交互作用 = -3.18；95% CI，-4.60 至 -1.75；P < .001），显示活动 tDCS 组的注意力不集中症状有所减轻。与假 tDCS 组相比的 3 项评估。轻度不良事件在主动 tDCS 组中更为常见，特别是皮肤发红、头痛和头皮烧伤。结论和相关性 在这项随机临床试验中，每天使用家用 tDCS 设备进行治疗超过 4 周，改善了未服用兴奋剂药物的成年 ADHD 患者的注意力。对于 ADHD 患者来说，家庭 tDCS 可能是一种非药物替代方案。试验注册 ClinicalTrials.gov 标识符：NCT04003740。