Cerebellar Continuous Theta Burst Stimulation for Insomnia Disorder: A Randomized Sham-Controlled Trial

To evaluate the effects of cerebellar continuous theta burst stimulation (cTBS) in insomnia disorder (ID).

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.

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.

Cerebellar cTBS was well tolerated and promising for ID.

ClinicalTrials.gov (NCT05992285).