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慢性偏头痛患者主动经颅磁刺激的随机、原理验证性临床试验

Randomized, proof-of-principle clinical trial of active transcranial magnetic stimulation in chronic migraine.

作者信息

Conforto Adriana B, Amaro Edson, Gonçalves André L, Mercante Juliane Pp, Guendler Vera Z, Ferreira Josione R, Kirschner Clara Cfb, Peres Mario Fp

机构信息

Instituto Israelita de Ensino e Pesquisa, Hospital Israelita Albert Einstein, Brazil.

出版信息

Cephalalgia. 2014 May;34(6):464-72. doi: 10.1177/0333102413515340. Epub 2013 Dec 10.

DOI:10.1177/0333102413515340
PMID:24326236
Abstract

BACKGROUND

High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex (rTMS-DLPFC) is an effective treatment for depression. Preliminary studies indicated beneficial effects of rTMS-DLPFC on pain relief in patients treated for depression, and in patients with chronic migraine.

METHODS

In this randomized, double-blind, parallel-group, single-center, proof-of-principle clinical trial, we tested the hypothesis that 23 sessions of active rTMS-DLPFC delivered over eight weeks would be feasible, safe and superior to sham rTMS to decrease the number of headache days in 18 patients with chronic migraine without severe depression. Per-protocol analysis was performed.

RESULTS

rTMS-DLPFC applied over eight weeks was feasible and safe in patients with chronic migraine. Contrary to our primary hypothesis, the number of headache days decreased significantly more in the sham group than in the group treated with active rTMS-DLPFC at eight weeks. Average decrease in headache days was >50% in the sham group, indicating a powerful placebo response. Pain intensity improved in both groups to a similar extent.

CONCLUSIONS

Positive results of M1 stimulation in other studies, and the absence of significant benefits of active high-frequency rTMS of the DLPFC in the present study, point to M1 as a more promising target than the DLPFC, for larger trials of noninvasive brain stimulation in patients with chronic migraine.

摘要

背景

高频重复经颅磁刺激左侧背外侧前额叶皮质(rTMS-DLPFC)是治疗抑郁症的一种有效方法。初步研究表明,rTMS-DLPFC对抑郁症患者以及慢性偏头痛患者的疼痛缓解具有有益作用。

方法

在这项随机、双盲、平行组、单中心的原理验证临床试验中,我们检验了以下假设:在八周内进行23次主动rTMS-DLPFC治疗对于减少18例无严重抑郁症的慢性偏头痛患者的头痛天数是可行、安全的,且优于假rTMS。进行了符合方案分析。

结果

在慢性偏头痛患者中,八周内应用rTMS-DLPFC是可行且安全的。与我们的主要假设相反,在八周时,假刺激组的头痛天数显著减少得比主动rTMS-DLPFC治疗组更多。假刺激组头痛天数的平均减少幅度>50%,表明存在强大的安慰剂效应。两组的疼痛强度改善程度相似。

结论

其他研究中M1刺激的阳性结果,以及本研究中DLPFC的主动高频rTMS未显示出显著益处,这表明对于慢性偏头痛患者的无创脑刺激更大规模试验而言,M1是比DLPFC更有前景的靶点。

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