Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Advanced Mental Health Care Inc., Royal Palm Beach, Florida, USA.
JCI Insight. 2023 Feb 22;8(4):e165271. doi: 10.1172/jci.insight.165271.
BACKGROUNDMajor depressive disorder (MDD) can benefit from novel interventions and personalization. Deep transcranial magnetic stimulation (Deep TMS) targeting the lateral prefrontal cortex (LPFC) using the H1 coil was FDA cleared for treatment of MDD. However, recent preliminary data indicate that targeting the medial prefrontal cortex (MPFC) using the H7 coil might induce outcomes that are as good or even better. Here, we explored whether Deep TMS targeting the MPFC is noninferior to targeting the LPFC and whether electrophysiological or clinical markers for patient selection can be identified.METHODSThe present prospective, multicenter, randomized study enrolled 169 patients with MDD for whom antidepressants failed in the current episode. Patients were randomized to receive 24 Deep TMS sessions over 6 weeks, using either the H1 coil or the H7 coil. The primary efficacy endpoint was the change from baseline to week 6 in Hamilton Depression Rating Scale scores.RESULTSClinical efficacy and safety profiles were similar and not significantly different between groups, with response rates of 60.9% for the H1 coil and 64.2% for the H7 coil. Moreover, brain activity measured by EEG during the first treatment session correlated with clinical outcomes in a coil-specific manner, and a cluster of baseline clinical symptoms was found to potentially distinguish between patients who can benefit from each Deep TMS target.CONCLUSIONThis study provides a treatment option for MDD, using the H7 coil, and initial guidance to differentiate between patients likely to respond to LPFC versus MPFC stimulation targets, which require further validation studies.TRIAL REGISTRATIONClinicalTrials.gov NCT03012724.FUNDINGBrainsWay Ltd.
重度抑郁症(MDD)可以从新的干预措施和个性化治疗中获益。使用 H1 线圈针对外侧前额叶皮层(LPFC)的深部经颅磁刺激(Deep TMS)已获得美国食品和药物管理局(FDA)批准,用于治疗 MDD。然而,最近的初步数据表明,使用 H7 线圈针对内侧前额叶皮层(MPFC)进行治疗可能会产生同样甚至更好的效果。在这里,我们探讨了针对 MPFC 的 Deep TMS 是否不劣于针对 LPFC 的治疗,以及是否可以确定用于患者选择的电生理或临床标志物。
本前瞻性、多中心、随机研究纳入了 169 名在当前发作中抗抑郁药治疗失败的 MDD 患者。患者被随机分为两组,分别接受 6 周的 24 次 Deep TMS 治疗,使用 H1 线圈或 H7 线圈。主要疗效终点是从基线到第 6 周汉密尔顿抑郁评定量表(HAMD)评分的变化。
两组的临床疗效和安全性特征相似,无显著性差异,H1 线圈的反应率为 60.9%,H7 线圈的反应率为 64.2%。此外,在第一次治疗过程中通过 EEG 测量的脑活动以线圈特异性的方式与临床结果相关,并且发现一组基线临床症状可能有助于区分每个 Deep TMS 靶点的受益患者。
这项研究为 MDD 提供了一种使用 H7 线圈的治疗选择,并初步指导区分可能对 LPFC 与 MPFC 刺激靶点有反应的患者,这需要进一步的验证研究。
ClinicalTrials.gov NCT03012724。
BrainsWay Ltd.