Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps.
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps.
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4x1高清经颅直流电流刺激（HD-TDC）的耐受性和盲目性为两毫安。
DOI：
10.1016/j.brs.2018.04.022
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发表时间：
2018-09
影响因子：
7.7
通讯作者：
Hampstead BM
中科院分区：
文献类型：
--
作者：
Reckow J;Rahman-Filipiak A;Garcia S;Schlaefflin S;Calhoun O;DaSilva AF;Bikson M;Hampstead BM
经颅直流电刺激（tDCS）是一种需求形式的神经调节，通常被认为是安全和耐受性良好的。然而，很少有研究检查了高清晰度（HD-）tDCS的安全性、耐受性或盲性，特别是在老年人和2毫安（mA）或更高刺激强度下。我们检查了严重不良事件和常见副作用的发生率，以分别确定HD-tDCS的安全性和耐受性。使用参与者正确陈述其病情的准确性（即，活性或假的）。样本包括101名老年人（法师= 69.69，SD = 8.33; Meduc = 16.27，SD = 2.42），他们参与了我们的双盲随机对照研究或在2 mA（n = 66，31例活动）或3 mA（n = 35，20例活动）下使用HD-tDCS 20-30分钟的病例研究。参与者完成了一份标准化的副作用问卷，并在每次会议结束时询问他们是否接受了主动或假刺激。没有严重的不良事件，也没有参与者退出，这表明HD-tDCS符合基本的安全性参数。在第一阶段，无论强度（2 mA和3 mA）如何，活性和假HD-tDCS之间的耐受性相当（所有p> 0.09）。刺痛是最常认可的项目（59%活性; 56%假），其次是烧灼感（51%活性; 50%假），其中大多数性质为轻度。“严重”评级报告在不到4%的会议。由于正确陈述其刺激条件的个体之间没有显著的组间差异（χ2 = 0.689，p = 0.679），因此设盲似乎足够。当多次治疗数据（即，共186次会议）。HD-tDCS在老年人中表现出良好的耐受性和安全性，即使在3 mA下也具有有效的假对照。这些数据支持在随机对照试验和临床翻译工作中使用HD-tDCS。
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 (Mage = 69.69, SD = 8.33; Meduc = 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 minutes 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 (all p>.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.
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DOI：
10.1016/j.trci.2017.04.008
发表时间：
2017-09
期刊：
Alzheimer's & dementia (New York, N. Y.)
影响因子：
--
作者：
Hampstead BM;Sathian K;Bikson M;Stringer AY
通讯作者：
Stringer AY
影响因子：
5.7
作者：
Edwards, Dylan;Cortes, Mar;Datta, Abhishek;Minhas, Preet;Wassermann, Eric M.;Bikson, Marom
通讯作者：
Bikson, Marom
影响因子：
1.7
作者：
Hampstead BM;Briceño EM;Mascaro N;Mourdoukoutas A;Bikson M
通讯作者：
Bikson M
重新思考经颅直流刺激的临床试验：参与者和评估者的盲目性在2MA的强度下不足。
影响因子：
3.7
作者：
O'Connell NE;Cossar J;Marston L;Wand BM;Bunce D;Moseley GL;De Souza LH
通讯作者：
De Souza LH
影响因子：
7.7
作者：
Garnett, Emily O.;den Ouden, Dirk-Bart
通讯作者：
den Ouden, Dirk-Bart