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Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study
Abstract
Invasive vagus nerve stimulation has been demonstrated to be an effective treatment in major depressive episodes. Recently, a novel non-invasive method of stimulating the vagus nerve on the outer canal of the ear has been proposed. In healthy subjects, a prominent fMRI BOLD signal deactivation in the limbic system was found. The present pilot study investigates the effects of this novel technique of auricular transcutaneous electric nerve stimulation in depressed patients for the first time. A total of 37 patients suffering from major depression were included in two randomized sham controlled add-on studies. Patients were stimulated five times a week on a daily basis for the duration of 2 weeks. On days 0 and 14, the Hamilton Depression Rating Scale (HAMD) and the Beck Depression Inventory (BDI) were assessed. In contrast to sham-treated patients, electrically stimulated persons showed a significantly better outcome in the BDI. Mean decrease in the active treatment group was 12.6 (SD 6.0) points compared to 4.4 (SD 9.9) points in the sham group. HAMD score did not change significantly in the two groups. An antidepressant effect of a new transcutaneous auricular nerve stimulation technique has been shown for the first time in this controlled pilot study. Regarding the limitations of psychometric testing, the risk of unblinding for technical reasons, and the small sample size, further studies are necessary to confirm the present results and verify the practicability of tVNS in clinical fields.
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“One randomized controlled trial[13] reported adequate random sequence generation (selection bias), while concealment of allocation was unclear in this RCT study.”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [13]
In the citing paper
“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 [13]
In the citing paper
“One randomized controlled trial[13] reported adequate random sequence generation (selection bias), while concealment of allocation was unclear in this RCT study.”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [13]
In the citing paper
“Another study reported that there were no adverse side effects after the taVNS intervention.[13]”
From Transcutaneous auricular vagus nerve stimulation in treating major depressive disorder: A systematic review and meta-analysis (2018) · cites this paper as [13]
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Metadata
- Authors
- Hein, E., Nowak, M., Kiess, O., Biermann, T., Bayerlein, K., Kornhuber, J., & Kraus, T.
- Affiliations
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Corresponding author
- Hein, Ernst
- Venue
- Journal of Neural Transmission
- Published
- 2012-11-02
- Volume
- 120
- Issue
- 5
- Pages
- 821-827
- ISSN
- 0300-9564 (ISSN-L)
- 1435-1463
- OpenAlex
- W2024665687
- Cited by
- 282
- References
- 34
- Citations by year
- 2026: 14 · 2025: 29 · 2024: 33 · 2023: 37 · 2022: 31 · 2021: 39 · 2020: 22 · 2019: 13 · 2018: 20 · 2017: 14 · 2016: 13 · 2015: 9 · 2014: 8
- FWCI
- 2.73
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Journal of Neural Transmission (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Keywords
- major depressive disorder, non-invasive vagus nerve stimulation, antidepressant effects, BOLD signal, depression rating scales
- MeSH terms
- Adult, Aged, Antidepressive Agents, Brain, Depression, Transcutaneous Electric Nerve Stimulation, Female, Humans, Male, Middle Aged, Pilot Projects, Psychiatric Status Rating Scales, Vagus Nerve, Statistics, Nonparametric
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