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

Abstract

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)

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BibTeX RIS

BibTeX

@article{liu2026cerebellar,
  title = {{Cerebellar Continuous Theta Burst Stimulation for Insomnia Disorder: A Randomized Sham‐Controlled Trial}},
  author = {Xin‐Yao Liu and Dong Dong and Chang‐Geng Song and Yu‐Xuan Ma and Dian‐Wei Wu and Xuan Wang and Jian‐Min Hao and Hui Li and Jing‐Jing Zhao and Geng‐Yao Hu and Feng Xia and Wen Jiang},
  journal = {CNS Neuroscience \& Therapeutics},
  year = {2026},
  month = oct,
  doi = {10.1002/cns.71231},
  url = {https://doi.org/10.1002/cns.71231},
  note = {CC BY 4.0},
}

RIS

TY  - JOUR
TI  - Cerebellar Continuous Theta Burst Stimulation for Insomnia Disorder: A Randomized Sham‐Controlled Trial
AU  - Xin‐Yao Liu
AU  - Dong Dong
AU  - Chang‐Geng Song
AU  - Yu‐Xuan Ma
AU  - Dian‐Wei Wu
AU  - Xuan Wang
AU  - Jian‐Min Hao
AU  - Hui Li
AU  - Jing‐Jing Zhao
AU  - Geng‐Yao Hu
AU  - Feng Xia
AU  - Wen Jiang
PY  - 2026
DA  - 2026/10/01
JO  - CNS Neuroscience & Therapeutics
DO  - 10.1002/cns.71231
UR  - https://doi.org/10.1002/cns.71231
AB  - 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)
SN  - 1755-5930
SN  - 1755-5949
ER  -

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