Veterans Affairs Ann Arbor Healthcare System, Mental Health Service (116B), Ann Arbor, MI, USA; University of Michigan, Department of Psychiatry, Ann Arbor, MI, USA.
University of Michigan, Department of Psychiatry, Ann Arbor, MI, USA.
Brain Stimul. 2018 Sep-Oct;11(5):991-997. doi: 10.1016/j.brs.2018.04.022. Epub 2018 May 4.
Transcranial direct current stimulation (tDCS) is an in-demand form of neuromodulation generally regarded as safe and well tolerated. However, few studies have examined the safety, tolerability, or blinding of High Definition (HD-) tDCS, especially in older adults and at stimulation intensities of 2 milliamps (mA) or greater.
We examined the rates of serious adverse events and common side effects to establish safety and tolerability, respectively, in HD-tDCS. Blinding was evaluated using participants' accuracy in correctly stating their condition (i.e., active or sham).
The sample included 101 older adults (M = 69.69, SD = 8.33; M = 16.27, SD = 2.42) who participated in our double blind randomized controlled studies or in case studies that used HD-tDCS for 20-30 min at 2 mA (n = 66, 31 active) or 3 mA (n = 35, 20 active). Participants completed a standardized side effect questionnaire and were asked whether they received active or sham stimulation at the end of each session.
There were no serious adverse events and no participants withdrew, suggesting that HD-tDCS meets basic safety parameters. Tolerability was comparable between active and sham HD-tDCS regardless of intensity (2 mA and 3 mA) in first session (allp > .09). Tingling was the most commonly endorsed item (59% active; 56% sham) followed by burning sensation (51% active; 50% sham), the majority of which were mild in nature. "Severe" ratings were reported in fewer than 4% of sessions. Blinding appeared adequate since there were no significant group differences between individuals correctly stating their stimulation condition (χ2 = 0.689, p = .679). The above tolerability and blinding findings generally persisted when multiple session data (i.e., 186 total sessions) were considered.
HD-tDCS appears well-tolerated and safe with effective sham-control in older adults, even at 3 mA. These data support the use of HD-tDCS in randomized controlled trials and clinical translation efforts.
经颅直流电刺激（tDCS）是一种需求较高的神经调节形式，通常被认为是安全且耐受良好的。然而，很少有研究检查高清晰度（HD-）tDCS 的安全性、耐受性或盲法，尤其是在老年人中以及刺激强度为 2 毫安（mA）或更高时。
我们分别检查严重不良事件和常见副作用的发生率，以确定 HD-tDCS 的安全性和耐受性。通过参与者正确陈述其状态（即活动或假）的准确性来评估盲法。
该样本包括 101 名老年人（M=69.69，SD=8.33；M=16.27，SD=2.42），他们参加了我们的双盲随机对照研究或使用 HD-tDCS 进行 20-30 分钟的案例研究，刺激强度为 2 mA（n=66，31 例为活动组）或 3 mA（n=35，20 例为活动组）。参与者完成了标准化的副作用问卷，并在每次治疗结束时被问及他们接受的是活动还是假刺激。
没有严重不良事件，也没有参与者退出，这表明 HD-tDCS 符合基本的安全性参数。在第一次治疗中，无论刺激强度（2 mA 和 3 mA）如何，活动组和假刺激组的耐受性均无差异（p>0.09）。刺痛是最常被认可的项目（59%的活动组；56%的假刺激组），其次是烧灼感（51%的活动组；50%的假刺激组），大多数是轻度的。不到 4%的治疗中报告了“严重”评分。由于个体正确陈述其刺激状态时，两组之间没有显著差异（χ2=0.689，p=0.679），因此盲法似乎是有效的。当考虑多个疗程的数据（即 186 个总疗程）时，上述耐受性和盲法发现基本保持不变。
即使在 3 mA 时，HD-tDCS 在老年人中耐受性良好且安全，并且具有有效的假刺激对照。这些数据支持在随机对照试验和临床转化研究中使用 HD-tDCS。
