小脑连续θ爆发刺激治疗失眠障碍：一项随机假刺激对照试验。
完整摘要 · 中文译文
目的：评估小脑连续θ脉冲刺激（cTBS）对失眠障碍（ID）的疗效。 方法：在这项随机假刺激对照试验中，失眠障碍患者接受了为期2周的活动性或假性小脑cTBS治疗。主要结局指标为治疗后匹兹堡睡眠质量指数（PSQI）评分改善≥3分。次要结局指标包括睡眠、情绪及静息态功能磁共振成像的变化。 结果：意向性治疗分析纳入了72例患者（其中女性51例；平均年龄44.3±11.6岁）。活动性组治疗后PSQI评分改善≥3分的患者比例高于假刺激组（75.0% 对 33.3%；校正后OR，6.06；95% CI，2.17-18.50；p < 0.001）。与假刺激相比，活动性cTBS在治疗后（校正后平均差异，-3.34；95% CI，-4.57至-2.12；p < 0.001）及1个月时（-3.70；95% CI，-4.93至-2.48；p < 0.001）均降低了PSQI评分，并且在两个时间点均改善了失眠严重程度指数、汉密尔顿焦虑量表和汉密尔顿抑郁量表评分（均p < 0.01）。探索性功能磁共振成像分析发现了两组间治疗后若干连接性的差异，但仅右侧杏仁核-右侧眶额叶连接性显示出显著的组别与时间交互作用（FDR校正后p = 0.038）。未发生严重不良事件。 结论：小脑cTBS耐受性良好，对失眠障碍具有治疗前景。 试验注册：ClinicalTrials.gov（NCT05992285）。
完整摘要 · 英文原文
OBJECTIVE: To evaluate the effects of cerebellar continuous theta burst stimulation (cTBS) in insomnia disorder (ID). METHODS: In this randomized sham-controlled trial, patients with ID received 2 weeks of active or sham cerebellar cTBS. The primary outcome was a ≥ 3-point improvement in Pittsburgh Sleep Quality Index (PSQI) score after treatment. Secondary outcomes included changes in sleep, mood, and resting-state fMRI. RESULTS: Seventy-two patients (51 women; mean age, 44.3 ± 11.6 years) were included in the intention-to-treat analysis. More patients in the active than sham group achieved a ≥ 3-point PSQI improvement after treatment (75.0% vs. 33.3%; adjusted OR, 6.06; 95% CI, 2.17-18.50; p < 0.001). Active cTBS reduced PSQI scores versus sham both post-treatment (adjusted mean difference, -3.34; 95% CI, -4.57 to -2.12; p < 0.001) and at 1 month (-3.70; 95% CI, -4.93 to -2.48; p < 0.001), and also improved Insomnia Severity Index, Hamilton Anxiety Scale, and Hamilton Depression Scale at both time points (all p < 0.01). Exploratory fMRI analyses identified several post-treatment connectivity differences between groups, but only right amygdala-right orbitofrontal connectivity showed a significant group-by-time interaction (FDR-adjusted p = 0.038). No serious adverse events occurred. CONCLUSION: Cerebellar cTBS was well tolerated and promising for ID. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05992285).