Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder: a nonrandomized controlled pilot study
Open accessAbstract
Background Depression presents a significant burden to both patients and society. One treatment that has emerged is vagus nerve stimulation (VNS), an FDA-approved physical treatment for depressive disorders. However, the application of this intervention has been limited by the involvement of surgery and potential side effects. The aim of this study is to explore the effectiveness of stimulating the superficial branches of the vagus nerve as a solo treatment for MDD.Methods This is a nonrandomized, controlled study. The first cohort of patients (n=91) only received transcutaneous auricular VNS (taVNS) for 12 weeks. In the second cohort (n=69), patients first received 4 weeks of sham taVNS followed by 8 weeks of taVNS. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary outcome measurement was the 24-item Hamilton Depression Rating Scale measured at weeks 0, 4, 8, and 12. Data analysis included a timelag analysis comparing (1) real and sham taVNS groups at week 4; (2) the real taVNS group at week 4 vs the sham taVNS group at week 8 (fourth week of real taVNS following 4 weeks of sham); and (3) the real taVNS group at week 8 vs the sham taVNS group at week 12 (eighth week of real taVNS following sham).Results After four weeks of treatment, MDD patients in the taVNS group showed greater improvement than patients in the sham taVNS group as indicated by Hamilton score changes as well as response and remission rates at week four. In addition, we also found that the clinical improvements continued until week 12 during taVNS.Limitations Patients were not randomized in this study.Conclusions Our results suggest that taVNS is a promising, safe, and cost-effective therapeutic method for mild and moderate MDD.
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Transcutaneous VNS allows for a non-invasive stimulation of the vagus nerve without any surgical procedure, with the stimulator usually attached to the auricular concha via ear clips and delivering electrical impulses at the subcutaneous course of the afferent auricular branch of the vagus nerve.
“In contrast to iVNS, transcutaneous VNS (tVNS) allows for a non-invasive stimulation of the vagus nerve without any surgical procedure. Here, the stimulator is usually attached to the auricular concha via ear clips and delivers electrical impulses at the subcutaneous course of the afferent auricular branch of the vagus nerve (77).”
From Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders (2018) · cites this paper as [77]
Decreased hippocampal activity after VNS has been reported in depression and schizophrenia.
“Decreased hippocampal activity after VNS has been reported in a number of other studies in other conditions such as depression (77, 167) or schizophrenia (168).”
From Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders (2018) · cites this paper as [77]
One study reported that 2 patients who underwent taVNS and 3 patients who underwent sham taVNS had mild tinnitus side effects but recovered quickly after cessation of the taVNS intervention.
“One study reported that 2 patients who underwent taVNS and 3 patients who underwent sham taVNS had mild tinnitus side effects but recovered quickly after cessation of the taVNS intervention.[14]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [14]
The interventions used in the control groups were all sham taVNS.
“The interventions used in the control groups were all sham taVNS.[13–15]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [14]
Confounding bias was not reported in the two non-RCT studies.
“In contrast, the confounding bias was not reported in any of these 2 trials.[14,15]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [14]
Among the 3 included studies, there was one randomized controlled trial and 2 nonrandomized controlled trials.
“Among the 3 included studies, there was one randomized controlled trial and 2 nonrandomized controlled trials.[13–15]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [14]
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Self-citationNon-invasive vagal nerve stimulation enhances cognitive emotion regulation
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Self-citationControl of inflammation using non-invasive neuromodulation: past, present and promise
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- Authors
- Rong, P., Liu, J., Wang, L., Liu, R., Fang, J., Zhao, J., Zhao, Y., Wang, H., Vangel, M., Sun, S., Ben, H., Park, J., Li, S., Meng, H., Zhu, B., & Kong, J.
- Affiliations
- China Academy of Chinese Medical Sciences (CN)
- Beijing University of Chinese Medicine (CN)
- Harvard University (US)
- Corresponding author
- Rong, Peijing
- Kong, Jian
- ORCID
- Venue
- Journal of Affective Disorders
- Publisher
- Elsevier BV
- Published
- 2016-05
- Volume
- 195
- Pages
- 172-179
- ISSN
- 0165-0327 (ISSN-L)
- PMC
- PMC4828906
- OpenAlex
- W2270807063
- Cited by
- 297
- References
- 43
- Citations by year
- 2026: 36 · 2025: 41 · 2024: 42 · 2023: 32 · 2022: 31 · 2021: 41 · 2020: 24 · 2019: 13 · 2018: 16 · 2017: 14 · 2016: 7
- FWCI
- 9.13
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Affective Disorders (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Chinese Medicine of the National Basic Research Program of China (2012CB518503)
- National Science and Technology Support Program of China (2012BAF14B10)
- Beijing Natural Science Foundation of China (7111007)
- NCCIH/NIH (R01AT006364, R01AT008563, R21AT008707, P01 AT006663)
- Topics
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- transcutaneous auricular vagus nerve stimulation, major depressive disorder, vagus nerve stimulation, sham stimulation, Hamilton Depression Rating Scale, treatment response and remission
- MeSH terms
- Adult, Major Depressive Disorder, Depressive Disorder, Major, Transcutaneous Electric Nerve Stimulation, Female, Humans, Male, Middle Aged, Pilot Projects, Psychiatric Status Rating Scales, Remission Induction, Self Administration, Cohort Studies, Treatment Outcome, Ear Auricle, Vagus Nerve Stimulation
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