What question did this study set out to answer?

The study aims to identify neural mechanisms and predictive biomarkers for treatment response to taVNS in primary insomnia patients.

January 10, 2026BMC Psychiatry0 citationsOpen Access

Predicting treatment response to transcutaneous auricular vagus nerve stimulation in patients with insomnia: resting-state functional connectivity based multivoxel pattern analysis

MQMeng QiGuangzhou University of Chinese Medicine SLSongna LiGuangzhou University of Chinese Medicine XWXiao WuUniversity of Electronic Science and Technology of China

Key Result

Transcutaneous auricular vagus nerve stimulation improved clinical outcomes in primary insomnia patients, with baseline left insula-visual/auditory connectivity predicting treatment response.

Key Points

The study aims to identify neural mechanisms and predictive biomarkers for treatment response to taVNS in primary insomnia patients.
Conducted a double-blind trial with 67 primary insomnia patients receiving taVNS or sham treatment.
Performed resting-state fMRI to assess functional connectivity at baseline and after 4 weeks.
Analyzed treatment-induced changes in bilateral insula-cortical connectivity and predictive value of baseline connectivity.
The taVNS group showed significant improvement in clinical assessments compared to the sham group.
Decreased resting-state functional connectivity was noted between the left insula and other brain areas.
Baseline functional connectivity in the left insula-visual/auditory circuit correlated with improvement in sleep disturbances.

Structured PICO

Does transcutaneous auricular vagus nerve stimulation improve sleep quality in patients with primary insomnia?

Population

67 patients with primary insomnia (aged 18-65 years, right-handed, PSQI > 7, SAS < 59, SDS < 62), mean age 42.88-44.91, predominantly female.

Intervention

Transcutaneous auricular vagus nerve stimulation (taVNS) at the left cymba conchae and cavity of conchae (20 Hz for 10 s, 4 Hz for 5 s), 30 minutes per session, twice daily, 5 days a week for 4 weeks.

Comparator

Sham transcutaneous auricular vagus nerve stimulation (staVNS) at the left tail of the helix with identical stimulation parameters, 30 minutes per session, twice daily, 5 days a week for 4 weeks.

Outcome

Pittsburgh Sleep Quality Index (PSQI) total score at 4 weeks.patient reported

Transcutaneous auricular vagus nerve stimulation significantly improves sleep quality in primary insomnia, with baseline insula functional connectivity serving as a potential predictive biomarker.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

BACKGROUND: The salience network, with the insula as its central hub, plays a pivotal role in the pathophysiology of primary insomnia (PI). Transcutaneous auricular vagus nerve stimulation (taVNS) shows therapeutic potential, its neural mechanisms and predictive biomarkers remain uncharacterized. METHODS: In a double-blind trial, 67 PI patients (taVNS = 34, sham = 33) underwent clinical assessments and resting-state fMRI at baseline and after 4-week treatment. We analyzed:1)Treatment-induced changes in bilateral insula-cortical functional connectivity (FC); 2)Predictive value of baseline FC using support vector regression. RESULTS: TaVNS group showed significantly improved clinical assessment compared with staVNS. Decreased rs-FCs were found between the left insula and areas involved in DMN(superior parietal gyrus, SPG), Visual/Auditory (superior occipital gyrus, SOG; middle occipital gyrus, MOG; calcarine and middle temporal gyrus, MTG) and cingulo-opercular network(middle frontal gyrus, MFG and cerebellum).In addition, decreased FC between left insula and left cerebellum correlated negatively with sleep disturbances score improvement ( CONCLUSIONS: TaVNS may alleviate PI symptoms by reducing FCs between the salience and task-positive networks and within the cingulo-opercular network to reduce visual-related overactivity and hypervigilance.The baseline functional connectivity in the left insula-visual/auditory circuit could act as a candidate biomarker for predicting taVNS treatment response, which enable the screen of therapy-responsive insomnia patients before treatment. CLINICAL TRIALS REGISTRATION: Chinese Clinical Trial Registry (ChiCTR 1900022535, 2019-04-16). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12888-025-07484-x.

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