School of Physics, Faculty of Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
THESS, Thessaloniki Software Solution S.A., Thessaloniki, Greece.
PLoS One. 2022 Aug 30;17(8):e0263145. doi: 10.1371/journal.pone.0263145. eCollection 2022.
The FDA cleared deep transcranial magnetic stimulation (Deep TMS) with the H7 coil for obsessive-compulsive disorder (OCD) treatment, following a double-blinded placebo-controlled multicenter trial. Two years later the FDA cleared TMS with the D-B80 coil on the basis of substantial equivalence. In order to investigate the induced electric field characteristics of the two coils, these were placed at the treatment position for OCD over the prefrontal cortex of a head phantom, and the field distribution was measured. Additionally, numerical simulations were performed in eight Population Head Model repository models with two sets of conductivity values and three Virtual Population anatomical head models and their homogeneous versions. The H7 was found to induce significantly higher maximal electric fields (p<0.0001, t = 11.08) and to stimulate two to five times larger volumes in the brain (p<0.0001, t = 6.71). The rate of decay of electric field with distance is significantly slower for the H7 coil (p < 0.0001, Wilcoxon matched-pairs test). The field at the scalp is 306% of the field at a 3 cm depth with the D-B80, and 155% with the H7 coil. The H7 induces significantly higher intensities in broader volumes within the brain and in specific brain regions known to be implicated in OCD (dorsal anterior cingulate cortex (dACC), dorsolateral prefrontal cortex (dlPFC), inferior frontal gyrus (IFG), orbitofrontal cortex (OFC) and pre-supplementary motor area (pre-SMA)) compared to the D-B80. Significant field ≥ 80 V/m is induced by the H7 (D-B80) in 15% (1%) of the dACC, 78% (29%) of the pre-SMA, 50% (20%) of the dlPFC, 30% (12%) of the OFC and 15% (1%) of the IFG. Considering the substantial differences between the two coils, the clinical efficacy in OCD should be tested and verified separately for each coil.
美国食品药品监督管理局(FDA)在一项双盲安慰剂对照多中心试验后,批准了使用 H7 线圈的深层经颅磁刺激(Deep TMS)治疗强迫症(OCD)。两年后,FDA 根据实质等同性批准了使用 D-B80 线圈的 TMS。为了研究这两个线圈的感应电场特性,将它们放置在头模型的前额皮质 OCD 治疗位置,测量了场分布。此外,还在八个人群头部模型存储库模型中进行了数值模拟,使用了两组电导率值和三个虚拟人群解剖头部模型及其均匀版本。结果发现 H7 线圈可显著诱导更高的最大电场(p<0.0001,t = 11.08),并刺激大脑中的体积增加两到五倍(p<0.0001,t = 6.71)。H7 线圈的电场随距离衰减的速度明显较慢(p < 0.0001,Wilcoxon 配对检验)。D-B80 线圈头皮处的电场是 3 cm 深处电场的 306%,而 H7 线圈则为 155%。H7 线圈在大脑中更广泛的体积和已知与 OCD 相关的特定脑区(背侧前扣带回皮层(dACC)、背外侧前额叶皮层(dlPFC)、下额回(IFG)、眶额皮层(OFC)和补充运动区(pre-SMA))中诱导出显著更高的强度。与 D-B80 相比,H7 线圈可在 15%(1%)的 dACC、78%(29%)的 pre-SMA、50%(20%)的 dlPFC、30%(12%)的 OFC 和 15%(1%)的 IFG 中诱导出显著的电场≥80 V/m。考虑到两个线圈之间存在显著差异,应分别针对每个线圈对 OCD 的临床疗效进行测试和验证。