Safety and efficacy of low intensity transcranial ultrasound stimulation for depression: A single-blind randomized controlled clinical study

作者：Xin Cai, Wei Sun, Xiaodan Zheng, Ningding Ding, M. Luo, Yiting Tu, Qingqing Meng, Yang Liu, Shuangfei Ding, Bo Yuan, Xiaojing Long · 发表于：Journal of Affective Disorders · 年份：2025 · DOI：10.1016/j.jad.2025.120666 · 被引用次数：2 · 研究领域：Ultrasound and Hyperthermia Applications、Vagus Nerve Stimulation Research、Transcranial Magnetic Stimulation Studies

AIMS: This study aimed to confirm the safety and effectiveness of transcranial ultrasound stimulation (TUS) in treating depression by targeting a subregion of the left dorsolateral prefrontal cortex (dlPFC). METHODS: A single-blind, randomized, sham-controlled clinical study was conducted involving 24 patients with depression in the TUS group and 12 in the sham group. Participants underwent psychiatric assessments and functional MRI scans. We employed an MR-compatible transducer, integrating dual navigation through optical guidance and MR acoustic radiation force imaging, to accurately target Brodmann area 46 (BA46) of the left dlPFC. The treatment group received active TUS, while the sham group received identical treatment without energy output, followed by actual TUS treatment. RESULTS: Following treatment, the TUS group exhibited significant improvements in depression and anxiety scores, as well as sleep quality, with benefits lasting up to four weeks. The sham group showed minor improvements after sham stimulation, but these became significant after subsequent real TUS treatment. Functional connectivity analysis revealed changes in the TUS group, particularly in connectivity with regions implicated in emotion processing, including the subgenual anterior cingulate cortex, ventral posterior cingulate cortex, and precuneus, all of which correlated with symptom improvements. Adverse effects of TUS were minimal and well-tolerated. CONCLUSION: This study underscores the potenti...