Mahdavi Kennedy D, Jordan Sheldon E, Jordan Kaya G, Rindner Elisabeth S, Haroon Jonathan M, Habelhah Barshen, Becerra Sergio A, Surya Jean Rama, Venkatraman Victoria, Zielinski Margaret A, Spivak Norman M, Bystritsky Alexander, Kuhn Taylor P
The Regenesis Project, 2811 Wilshire Blvd, Suite 790, Los Angeles, CA, 90403, USA.
The Regenesis Project, 2811 Wilshire Blvd, Suite 790, Los Angeles, CA, 90403, USA; Department of Neurology, University of California, Los Angeles, 760 Westwood Plaza, B8-169, Los Angeles, CA, 90025, USA.
J Psychiatr Res. 2023 Oct 19;168:125-132. doi: 10.1016/j.jpsychires.2023.10.039.
This study intended to evaluate a possible therapeutic effect among patients with treatment-refractory generalized anxiety disorder (trGAD) by using transcranial focused ultrasound (tfUS) to modulate amygdalar activity.
Twenty-five participants with severe trGAD as outlined in the DSM-V were recruited from Los Angeles neurology and psychiatry clinics. All participants completed eight weekly 10-min tfUS sessions targeting the right amygdala. Functional and structural neuroimaging were used to navigate individual targets. Outcome measures including the Hamilton Anxiety Inventory (HAM-A, primary outcome) and Beck Anxiety Inventory (BAI) were collected at baseline and protocol completion. Upon study completion, participants were asked to report perceived change in clinical status using the Patient Global Impression - Improvement (PGI-I) scale. Data was collected from May 2020 through January 2023.
All participants were able to tolerate treatment without notable side effects. No adverse events were reported. A Wilcoxon Signed-Rank Test was conducted to compare pre- and post-tfUS measures of anxiety. tfUS resulted in a significant decrease in anxiety as measured by the HAM-A (W = -3.69, p < 0.001, pre-post-Δ = -12.64 ± 12.51) and the BAI (W = -3.94, p < 0.001, pre-post-Δ = -12.88 ± 10.42). Sixteen (16) of twenty-five (25) total participants indicated clinically significant benefit on PGI-I scores at completion.
This study provides preliminary evidence supporting the safety and efficacy of tfUS as a clinical intervention. These results warrant further investigation of tfUS as a therapeutic intervention for anxiety and other psychiatric and neurological disorders.
NCT04250441.
本研究旨在通过使用经颅聚焦超声（tfUS）调节杏仁核活动，评估其对难治性广泛性焦虑症（trGAD）患者的潜在治疗效果。
从洛杉矶的神经科和精神科诊所招募了25名符合《精神疾病诊断与统计手册》第五版（DSM-V）中重度trGAD标准的参与者。所有参与者均完成了为期八周、每周一次、每次10分钟、针对右侧杏仁核的tfUS治疗。使用功能和结构神经成像技术来确定个体治疗靶点。在基线和治疗方案结束时收集包括汉密尔顿焦虑量表（HAM-A，主要结局指标）和贝克焦虑量表（BAI）在内的结局指标。研究结束时，要求参与者使用患者整体印象改善量表（PGI-I）报告其临床状态的感知变化。数据收集时间为2020年5月至2023年1月。
所有参与者均能耐受治疗，且无明显副作用。未报告不良事件。采用Wilcoxon符号秩检验比较tfUS治疗前后的焦虑量表测量值。tfUS治疗后，HAM-A量表（W = -3.69，p < 0.001，治疗前后差值 = -12.64 ± 12.51）和BAI量表（W = -3.94，p < 0.001，治疗前后差值 = -12.88 ± 10.42）测量的焦虑水平显著降低。25名参与者中有16名在治疗结束时PGI-I评分显示出临床显著改善。
本研究提供了初步证据，支持tfUS作为一种临床干预措施的安全性和有效性。这些结果值得进一步研究tfUS作为焦虑症及其他精神和神经疾病的治疗干预手段。
NCT04250441。
