Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study
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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To date, only one small pilot study has employed VNS in schizophrenia and showed the intervention was well tolerated with an overall trend towards improved schizophrenia symptoms; however, compliance was low which questions the feasibility of a patient-controlled neurostimulation intervention.
“To date, only one small pilot study has employed VNS in SCZ and showed the intervention was well tolerated with an overall trend towards improved SCZ symptoms; however, compliance was low which questions the feasibility of a patient-controlled neurostimulation intervention112.”
From Autonomic nervous system dysfunction in schizophrenia: impact on cognitive and metabolic health (2021) · cites this paper as [112]
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- Authors
- Hasan, A., Wolff-Menzler, C., Pfeiffer, S., Falkai, P., Weidinger, E., Jobst, A., Hoell, I., Malchow, B., Yeganeh-Doost, P., Strube, W., Quast, S., Müller, N., & Wobrock, T.
- Affiliations
- Ludwig-Maximilians-Universität München (DE)
- University of Göttingen (DE)
- Corresponding author
- Hasan, Alkomiet
- ORCID
- Venue
- European Archives of Psychiatry and Clinical Neuroscience
- Published
- 2015-07-26
- Volume
- 265
- Issue
- 7
- Pages
- 589-600
- ISSN
- 0003-9373 (ISSN-L)
- 0940-1334
- 1433-8491
- OpenAlex
- W1921350334
- Cited by
- 80
- References
- 54
- Citations by year
- 2026: 1 · 2025: 10 · 2024: 10 · 2023: 8 · 2022: 10 · 2021: 12 · 2020: 11 · 2019: 2 · 2018: 5 · 2017: 4 · 2016: 3 · 2015: 4
- FWCI
- 2.84
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- European Archives of Psychiatry and Clinical Neuroscience (publishedVersion)
- PubMed (publishedVersion)
- GRO (submittedVersion)
- MPG.PuRe (Max Planck Society) (submittedVersion)
- OPUS (Augsburg University) (submittedVersion)
- Funders
- CerboMed GmbH
- Topics
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- transcutaneous vagus nerve stimulation, schizophrenia, auricular stimulation, neuromodulation, treatment efficacy, safety and tolerability, PANSS, medication adherence, neuropsychological outcomes
- MeSH terms
- Adult, Double-Blind Method, Transcutaneous Electric Nerve Stimulation, Female, Humans, Male, Middle Aged, Pilot Projects, Schizophrenia, Schizophrenic Psychology, Treatment Outcome, Cross-Over Studies, Vagus Nerve Stimulation, Young Adult
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