Cerebellar Continuous Theta Burst Stimulation for Insomnia Disorder: A Randomized Sham‐Controlled Trial
Xin‐Yao Liu, Dong Dong, Chang‐Geng Song, Yu‐Xuan Ma, Dian‐Wei Wu, Xuan Wang, Jian‐Min Hao, Hui Li, Jing‐Jing Zhao, Geng‐Yao Hu, Feng Xia, Wen JiangABSTRACT
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)