Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization.
Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization.
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高清经颅直流刺激对纤维肌痛疼痛的临床有效治疗：II期开放标签剂量优化。
DOI：
10.1016/j.jpain.2015.09.009
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发表时间：
2016-01
期刊：
影响因子：
--
通讯作者：
Fregni F
中科院分区：
文献类型：
--
作者：
Castillo-Saavedra L;Gebodh N;Bikson M;Diaz-Cruz C;Brandao R;Coutinho L;Truong D;Datta A;Shani-Hershkovich R;Weiss M;Laufer I;Reches A;Peremen Z;Geva A;Parra LC;Fregni F
尽管在治疗纤维肌痛（FM）疼痛方面取得了有希望的初步结果，但由于疗效有限、应答率低或耐受性差，在临床实践中尚未采用神经调节技术。这项II期开放标签试验旨在通过建立治疗方案和筛选程序来确定临床有效治疗FM疼痛的方法，以最大限度地提高疗效和缓解率。高清经颅直流电刺激（HD-tDCS）提供靶向阈下脑刺激，结合了耐受性和特异性。我们的目的是确定达到50% FM疼痛减轻所需的HD-tDCS会话数量，并表征反应的生物特征，包括接触热诱发电位的脑网络激活疼痛评分。我们报告了一半（n = 7）患者（N = 14）疼痛减轻50%的临床显著益处，应答者和无应答者都受益于治疗的累积效应，反映在随着时间的推移疼痛显著减轻（P = 0.035）以及生活质量改善（P = 0.001）。我们还报告了50%患者的6周总缓解率，并估计15次HD-tDCS治疗的中位次数可达到临床有意义的结局。因此，支持采用个体化治疗的关键FM神经调节临床试验的方法。
Despite promising preliminary results in treating fibromyalgia (FM) pain, no neuromodulation technique has been adopted in clinical practice because of limited efficacy, low response rate, or poor tolerability. This phase II open-label trial aims to define a methodology for a clinically effective treatment of pain in FM by establishing treatment protocols and screening procedures to maximize efficacy and response rate. High-definition transcranial direct current stimulation (HD-tDCS) provides targeted subthreshold brain stimulation, combining tolerability with specificity. We aimed to establish the number of HD-tDCS sessions required to achieve a 50% FM pain reduction, and to characterize the biometrics of the response, including brain network activation pain scores of contact heat-evoked potentials. We report a clinically significant benefit of a 50% pain reduction in half (n = 7) of the patients (N = 14), with responders and nonresponders alike benefiting from a cumulative effect of treatment, reflected in significant pain reduction (P = .035) as well as improved quality of life (P = .001) over time. We also report an aggregate 6-week response rate of 50% of patients and estimate 15 as the median number of HD-tDCS sessions to reach clinically meaningful outcomes. The methodology for a pivotal FM neuromodulation clinical trial with individualized treatment is thus supported.
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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：
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影响因子：
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影响因子：
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作者：
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影响因子：
3.5
作者：
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通讯作者：
Galhardo V
影响因子：
3
作者：
Minhas, Preet;Bansal, Varun;Patel, Jinal;Ho, Johnson S.;Diaz, Julian;Datta, Abhishek;Bikson, Marom
通讯作者：
Bikson, Marom