Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects.
Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects.
复制标题
重复应用经颅电刺激的耐受性，对健康受试者的输出有限。
DOI：
10.1016/j.brs.2016.05.008
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发表时间：
2016-09
影响因子：
7.7
通讯作者：
Bikson M
中科院分区：
文献类型：
--
作者：
Paneri B;Adair D;Thomas C;Khadka N;Patel V;Tyler WJ;Parra L;Bikson M
临床人群中有限输出量经颅电刺激(TES)的安全性和耐受性支持非重大风险指定。健康人群对长期使用的耐受性仍未进行测试。我们测试了两种TES波形的耐受性和依从性，即经颅直流电刺激(TDC)和调制高频经颅脉冲电流刺激(MHF-TPCS)，与假TDC相比，在公共环境中每周应用3-5天(每天17-20分钟)，最长可达6周。MHF-TPC由峰值幅度为10-20 mA的非对称高频脉冲(7-11 kHz)组成，由受试者调整，平均电流为5-7 mA。将100名治疗盲健康受试者随机分为三组：TDCs组(n=33)、MHF-TPCS组(n=30)和Sham-tDCs组(n=37)。为了测试波形的作用，在TES和Sham-tDCS臂上安装了电极类型和蒙太奇：右侧额部和颈部后部的大容量自附着电极。在为期六周的时间里，我们在研究志愿者身上进行了1905次治疗(636次假TDC，623次TDC，646次MHF-TPCS)。常见的不良反应主要限于对皮肤的影响，包括皮肤刺痛、瘙痒和轻微的灼热感。主动TES治疗组(MHF-TPC，TDC)的这些事件的发生率与假TDC治疗组相同或显著低于假TES治疗组。其他不良事件很少见(发生率为5%)，不能在不同的治疗组中明显区分。一些受试者因不典型头痛(假TDCSn=2，tDCSn=2，MHF-TPCS n=3)、不典型不适(Sham-tDCSn=0，tDCSn=1，MHF-TPCS n=1)或不典型皮肤刺激(Sham-tDCSn=2，tDCSn=8，MHF-TPCS n=1)而退出研究。MHF-TPCS组的依从率(所选会话完成)显著高于Sham-TDCS组(p=0.007)。在任何治疗条件下都没有发生严重的不良事件。我们的结论是，在较长的时间内重复应用有限的输出量TES，仅限于这里测试的硬件、电极和方案，在健康受试者中是可以很好地耐受的，就像以前在临床人群中观察到的那样。
The safety and tolerability of limited output transcranial electrical stimulation (tES) in clinical populations support a non-significant risk designation. The tolerability of long-term use in a healthy population had remained untested. We tested the tolerability and compliance of two tES waveforms, transcranial direct current stimulation (tDCS) and modulated high frequency transcranial pulsed current stimulation (MHF-tPCS) compared to sham-tDCS, applied to healthy subjects for three to five days (17–20 minutes per day) per week for up to six weeks in a communal setting. MHF-tPCS consisted of asymmetric high-frequency pulses (7–11 kHz) having a peak amplitude of 10–20 mA peak, adjusted by subject, resulting in an average current of 5–7 mA. A total of 100 treatment blind healthy subjects were randomly assigned to one of three treatment groups: tDCS (n = 33), MHF-tPCS (n = 30), or sham-tDCS (n = 37). In order to test the role of waveform, electrode type and montage were fixed across tES and sham-tDCS arms: high-capacity self-adhering electrodes on the right lateral forehead and back of the neck. We conducted 1905 sessions (636 sham-tDCS, 623 tDCS, and 646 MHF-tPCS sessions) on study volunteers over a period of six weeks. Common adverse events were primarily restricted to influences upon the skin and included skin tingling, itching, and mild burning sensations. The incidence of these events in the active tES treatment arms (MHF-tPCS, tDCS) was equivalent or significantly lower than their incidence in the sham-tDCS treatment arm. Other adverse events had a rarity (<5% incidence) that could not be significantly distinguished across the treatment groups. Some subjects were withdrawn from the study due to atypical headache (sham-tDCS n = 2, tDCS n = 2, and MHF-tPCS n = 3), atypical discomfort (sham-tDCS n = 0, tDCS n = 1, and MHF-tPCS n = 1), or atypical skin irritation (sham-tDCS n = 2, tDCS n = 8, and MHF-tPCS n = 1). The rate of compliance, elected sessions completed, for the MHF-tPCS group was significantly greater than the sham-tDCS group’s compliance (p = 0.007). There were no serious adverse events in any treatment condition. We conclude that repeated application of limited output tES across extended periods, limited to the hardware, electrodes, and protocols tested here, is well tolerated in healthy subjects, as previously observed in clinical populations.
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影响因子：
7.7
作者：
Brunoni, Andre Russowsky;Nitsche, Michael A.;Bolognini, Nadia;Bikson, Marom;Wagner, Tim;Merabet, Lotfi;Edwards, Dylan J.;Valero-Cabre, Antoni;Rotenberg, Alexander;Pascual-Leone, Alvaro;Ferrucci, Roberta;Priori, Alberto;Boggio, Paulo Sergio;Fregni, Felipe
通讯作者：
Fregni, Felipe
影响因子：
2.5
作者：
Fricke, K.;Seeber, A. A.;Rothwell, J. C.
通讯作者：
Rothwell, J. C.
影响因子：
2.5
作者：
Gladwin, Thomas E.;den Uyl, Tess E.;Wiers, Reinout W.
通讯作者：
Wiers, Reinout W.
影响因子：
3
作者：
Guleyupoglu, Berkan;Schestatsky, Pedro;Edwards, Dylan;Fregni, Felipe;Bikson, Marom
通讯作者：
Bikson, Marom
影响因子：
5.3
作者：
Harty, Siobhan;Robertson, Ian H.;O'Connell, Redmond G.
通讯作者：
O'Connell, Redmond G.