The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; BrainsWay Ltd, Israel.
The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; BrainsWay Ltd, Israel; Advanced Mental Health Care, 11903 Southern Blvd. Royal Palm Beach, FL 33411, USA.
J Psychiatr Res. 2021 May;137:667-672. doi: 10.1016/j.jpsychires.2020.11.009. Epub 2020 Nov 4.
Deep transcranial magnetic stimulation (dTMS) with the H7-coil was FDA cleared for obsessive-compulsive disorder (OCD) in August 2018 based on multicenter sham-controlled studies. Here we look at the efficacy of dTMS for OCD in real world practices.
All dTMS clinics were asked to supply their data on treatment details and outcome measures. The primary outcome measure was response, defined by at least a 30% reduction in the Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline to endpoint. Secondary outcome measures included first response, defined as the first time the YBOCS score has met response criteria, and at least one-month sustained response. Analyses included response rate at the endpoint (after 29 dTMS sessions), number of sessions and days required to reach first response and sustained response.
Twenty-two clinical sites with H7-coils provided data on details of treatment and outcome (YBOCS) measures from a total of 219 patients. One-hundred-sixty-seven patients who had at least one post-baseline YBOCS measure were included in the main analyses. Overall first and sustained response rates were 72.6% and 52.4%, respectively. The response rate was 57.9% in patients who had YBOCS scores after 29 dTMS sessions. First response was achieved in average after 18.5 sessions (SD = 9.4) or 31.6 days (SD = 25.2). Onset of sustained one-month response was achieved in average after 20 sessions (SD = 9.8) or 32.1 days (SD = 20.5). Average YBOCS scores demonstrated continuous reduction with increasing numbers of dTMS sessions.
In real-world clinical practice, the majority of OCD patients benefitted from dTMS, and the onset of improvement usually occurs within 20 sessions. Extending the treatment course beyond 29 sessions results in continued reduction of OCD symptoms, raising the prospect of value for extended treatment protocols in non-responders.
基于多中心假刺激对照研究,H7 线圈的深部经颅磁刺激(dTMS)于 2018 年 8 月获得美国食品药品监督管理局(FDA)批准用于强迫症(OCD)的治疗。在此,我们观察了 dTMS 在真实世界实践中的 OCD 治疗效果。
所有进行 dTMS 治疗的诊所均被要求提供治疗细节和结果测量的数据。主要结局指标为反应,定义为从基线到终点时耶鲁布朗强迫症量表(YBOCS)评分至少降低 30%。次要结局指标包括首次反应,定义为 YBOCS 评分首次达到反应标准的时间,以及至少持续一个月的反应。分析包括终点(29 次 dTMS 治疗后)时的反应率、达到首次反应和持续反应所需的治疗次数和天数。
22 个配备 H7 线圈的临床中心提供了关于 219 例患者治疗细节和 YBOCS 测量结果的资料。共有 167 例至少有一次基线后 YBOCS 测量值的患者被纳入主要分析。总的首次和持续反应率分别为 72.6%和 52.4%。在接受 29 次 dTMS 治疗后的患者中,反应率为 57.9%。平均在 18.5 次治疗(SD=9.4)或 31.6 天(SD=25.2)后达到首次反应。平均在 20 次治疗(SD=9.8)或 32.1 天(SD=20.5)后达到持续一个月的反应。随着 dTMS 治疗次数的增加,YBOCS 评分呈持续下降趋势。
在真实世界的临床实践中,大多数 OCD 患者从 dTMS 中获益,改善通常在 20 次治疗内出现。将治疗疗程延长至 29 次以上会导致 OCD 症状持续减轻,这为非应答者延长治疗方案提供了价值。