Trial reportEuropean archives of psychiatry and clinical neuroscience2015
Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study.
Trial report in European archives of psychiatry and clinical neuroscience, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 5 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials.Frontiers in neuroscience · 2023Pooled it
- Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis.Scientific reports · 2022Pooled it
- Pooled it
- Auricular Vagus Neuromodulation-A Systematic Review on Quality of Evidence and Clinical Effects.Frontiers in neuroscience · 2021Pooled it
- Vagus nerve stimulation in psychiatry: a systematic review of the available evidence.Journal of neural transmission (Vienna, Austria : 1996) · 2017Pooled it
- Efficacy and safety of transcutaneous auricular vagus nerve stimulation for patients with treatment-resistant schizophrenia with predominantly negative symptoms: a randomized clinical trial and efficacy sensitivity biomarkers.Molecular psychiatry · 2025Trial
- Transcutaneous auricular vagus nerve stimulation modifies cortical excitability in middle-aged and older adults.Psychophysiology · 2025Trial
- Autonomic and neural responses to varying transcutaneous cervical electrical stimulation parameters.Bioelectronic medicine · 2026Article
- Effect of transcutaneous auricular vagus nerve stimulation on the improvement of cognitive function in older patients with schizophrenia: A randomised controlled study.General psychiatry · 2026Article
- Unraveling the mysteries of schizophrenia: Insights into prefrontal cortex dysfunction and therapeutic implications.World journal of psychiatry · 2025Review
- Article
- Three Hundred Hertz Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Impacts Pupil Size Non-Linearly as a Function of Intensity.Psychophysiology · 2025Article
- Mechanisms of vagus nerve stimulation for the treatment of neurodevelopmental disorders: a focus on microglia and neuroinflammation.Frontiers in neuroscience · 2024Review
- Pairing transcutaneous vagus nerve stimulation with an intensive bimanual training in children and adolescents with cerebral palsy: study protocol of a randomized sham-controlled trial.Frontiers in neurology · 2024Article
- Self-Regulatory Neuronal Mechanisms and Long-Term Challenges in Schizophrenia Treatment.Brain sciences · 2023Review
- Noninvasive Vagal Nerve Stimulation for Opioid Use Disorder.Annals of depression and anxiety · 2023Article
- "The Wandering Nerve Linking Heart and Mind" - The Complementary Role of Transcutaneous Vagus Nerve Stimulation in Modulating Neuro-Cardiovascular and Cognitive Performance.Frontiers in neuroscience · 2022Review
- Role of the Cholinergic Anti-Inflammatory Reflex in Central Nervous System Diseases.International journal of molecular sciences · 2021Review
- Autonomic nervous system dysfunction in schizophrenia: impact on cognitive and metabolic health.NPJ schizophrenia · 2021Review
- Vagus nerve stimulation as a potential modulator of periictal psychotic episodes: A report of four cases.Epilepsy & behavior reports · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite many pharmacological and psychosocial treatment options, schizophrenia remains a debilitating disorder. Thus, new treatment strategies rooted in the pathophysiology of the disorder are needed. Recently, vagus nerve stimulation (VNS) has been proposed as a potential treatment option for various neuropsychiatric disorders including schizophrenia. The objective of this study was to investigate for the first time the feasibility, safety and efficacy of transcutaneous VNS in stable schizophrenia. A bicentric randomized, sham-controlled, double-blind trial was conducted from 2010 to 2012. Twenty schizophrenia patients were randomly assigned to one of two treatment groups. The first group (active tVNS) received daily active stimulation of the left auricle for 26 weeks. The second group (sham tVNS) received daily sham stimulation for 12 weeks followed by 14 weeks of active stimulation. Primary outcome was defined as change in the Positive and Negative Symptom Scale total score between baseline and week 12. Various other secondary measures were assessed to investigate safety and efficacy. The intervention was well tolerated with no relevant adverse effects. We could not observe a statistically significant difference in the improvement of schizophrenia psychopathology during the observation period. Neither psychopathological and neurocognitive measures nor safety measures showed significant differences between study groups. Application of tVNS was well tolerated, but did not improve schizophrenia symptoms in our 26-week trial. While unsatisfactory compliance questions the feasibility of patient-controlled neurostimulation in schizophrenia, the overall pattern of symptom change might warrant further investigations in this population.
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