Trial reportBMC medicine2025
Baseline functional connectivity of the basal forebrain-cortical circuit predict taVNS treatment response in primary insomnia: a randomized controlled trial and fMRI study.
Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Auricular Press-Needle Acupuncture Induces Specific Brain Functional Reorganization and Modulates Autonomic Nervous Activity: A Randomized Sham-Controlled Trial
Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Emergence Agitation and Delirium After Pediatric Tonsillectomy and Adenoidectomy: A Randomized, Double-Blind, Interventional Study
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy of auriculotherapies for primary insomnia: A systematic review and network meta-analysis.Medicine · 2026Pooled it
- Default mode network and visual network responsiveness to transcutaneous auricular vagus nerve stimulation predict its variable efficacy in primary insomnia disorder.Frontiers in neurology · 2025Trial
- A Multiscale Spatiotemporal Causal Mapping Algorithm for Revealing Neural Network Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation.Human brain mapping · 2026Article
- Article
- Physical factor therapies for insomnia: a narrative review of mechanisms, clinical evidence, and phenotype-guided applications.Frontiers in psychiatry · 2026Review
- Vagus Nerve Stimulation for Sleep Disorders: Emerging Evidence and Future Directions.Nature and science of sleep · 2026Review
- Transcutaneous auricular vagus nerve stimulation: mechanisms, applications, and research progress.Frontiers in neuroscience · 2026Review
- From Therapeutic Heterogeneity to Precision Neuromodulation: Non-Invasive Brain Stimulation for Chronic Insomnia.Nature and science of sleep · 2026Review
- Clinical efficacy and mechanisms of transcutaneous auricular vagus nerve stimulation targeting the gut-brain axis for postoperative complications of aortic dissection: study protocol for a randomized controlled trial.Frontiers in medicine · 2025Article
- Continuous auricular acupuncture and daytime intermittent electroacupuncture as a complementary therapeutic improve glycemic variability and stability under Continuous Glycemic Monitoring System in hospitalized diabetic patients.Frontiers in endocrinology · 2025Article
- Microbiota-gut-brain axis pathogenesis and targeted therapeutics in sleep disorders.Frontiers in neurology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundDysfunctional basal forebrain (BF) connectivity contributes to primary insomnia (PI). This study investigated whether transcutaneous auricular vagus nerve stimulation (taVNS) modulates BF functional connectivity (FC) in patients with PI and whether baseline FC predicts taVNS treatment response.
methodsSeventy patients with PI were randomized to real or sham taVNS for 4 weeks. Clinical assessments-including Pittsburgh Sleep Quality Index (PSQI], Insomnia Severity Index (ISI] and Zung's Self-Rating Anxiety (SAS], and Depression Scale (SDS)-and resting-state fMRI data were collected at baseline and after treatment. FC of the bilateral BF subregions (Ch_123, Ch_4) was analyzed, and pre-to-post intervention changes in FC and clinical scores were compared between groups. Baseline FC was used to predict treatment response using a support vector regression (SVR) model, validated on an independent dataset.
resultsSixty-seven patients completed the study (33 real taVNS, 34 sham taVNS). Changes in clinical outcomes showed that real taVNS significantly reduce PSQI, ISI, and SAS scores compared to sham. FC analysis revealed reduced connectivity between bilateral BF and areas involved in visual (superior occipital gyrus, SOG; middle occipital gyrus, MOG; fusiform gyrus, FFG), somatosensory (supplementary motor area, SMA) cortex and medial prefrontal cortex (mPFC) after taVNS treatment. Reduced FC between bilateral BF and left MOG correlated positively with ISI improvement (r = 0.490, p = 0.008, Bonferroni correction). The SVR model effectively predicted treatment response based on BF-visual circuit connectivity (r = 0.520, p = 0.0014, 5000 permutation test) and generalized well to an independent dataset (r = 0.443, p = 0.0354, 5000 permutation test).
conclusionsOur findings suggest that taVNS may alleviate symptoms of primary insomnia through modulation of basal forebrain connectivity with visual, sensorimotor, and medial prefrontal cortical regions. Preliminary investigations indicate that baseline functional connectivity in the BF-visual circuit could represent a candidate biomarker for taVNS response, potentially informing personalized treatment strategies.
trial registrationThe study was registered with the China Clinical Trial Registry (Clinical Trial No. ChiCTR1900022535).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.