突破性脑磁刺激疗法获FDA批准用于PTSD治疗，缓解率达68%

德州农工大学与Wave Neuroscience公司合作开发的个性化脑磁刺激疗法（MeRT）已获得FDA批准，用于治疗创伤后应激障碍（PTSD）。1这是首个获批的PTSD非药物治疗方案，临床试验结果显示患者症状减轻52%，68%的患者达到缓解，远超现有药物治疗效果。1相比之下，目前仅有的两种FDA批准PTSD药物——舍曲林和氟西汀（均为SSRI类）——的缓解率仅为10.9%。1

该疗法采用脑电图结合人工智能算法，根据患者个体脑活动定制个性化治疗方案。1患者每周接受5次治疗，疗程为5至6周。1德州农工大学精神病学教授Israel Liberzon表示："这是第一次，除了药物治疗外，我们有了非药物选择。"1Wave Neuroscience首席医疗官Erik Won指出，相比现有药物治疗，该疗法的症状减少52%，效能提高四倍以上，称之为"量子跃变"。1

美国约有1300万PTSD患者。1该项目从疫情期间启动至获得FDA批准仅用时两年多，远快于医疗器械的常规批准周期。1

A personalized brain stimulation therapy developed by Texas A&M University and Wave Neuroscience has received FDA approval for treating post-traumatic stress disorder, marking a significant milestone in non-pharmaceutical PTSD treatment 1. The therapy, known as magnetic e-resonance therapy (MeRT), demonstrated substantial clinical efficacy: patients experienced a 52% reduction in symptoms, with 68% achieving remission 1. These results vastly exceed outcomes from existing pharmaceutical approaches, which show symptom improvement of 6.8 to 10.1 points and remission rates as high as 10.9% 1.

MeRT uses electroencephalography and artificial intelligence algorithms to customize treatment protocols based on each patient's individual brain activity 1. Patients undergo five weekly sessions over a five- to six-week period 1. The breakthrough designation and FDA approval came remarkably quickly—within just over two years from project initiation during the COVID-19 pandemic, compared to the typical ten-year timeline for such approvals 1. Wave Neuroscience's Chief Medical Officer Erik Won emphasized the advancement, stating that the trial demonstrated "symptom reduction of 52%, more than four times the efficacy" of existing treatments, adding "we see 68% remission rates. This really is a quantum leap" 1. Israel Liberzon, a psychiatry professor at Texas A&M University, underscored the therapeutic significance: "This is the first time, beyond medication, we have a non-drug option" 1.

Currently, only two FDA-approved medications exist for PTSD treatment, both selective serotonin reuptake inhibitors—sertraline and fluoxetine 1. The new therapy addresses an urgent clinical need: approximately 13 million Americans live with PTSD, while roughly 17.5 military veterans die by suicide daily, with about 7% of veterans receiving a PTSD diagnosis annually 1.