The DOI matches its Crossref record; 51 of the 51 references it cites were found in a registry or an index.
Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review
Open accessAbstract
BACKGROUND Transcutaneous Vagus Nerve stimulation (tVNS) may be an alternative to surgically implanted VNS for epilepsy and other diseases. However, its safety and tolerability profile is unclear. OBJECTIVE We performed a systematic review of treatment harms from tVNS in humans. METHODS A systematic published and grey literature search was carried out to identify studies which deployed tVNS in human subjects. Study authors were contacted for safety/tolerability data if these were not available in the publication. Databases were searched from 1966 to May 2017. We noted study type, population, stimulation parameters, type and prevalence of side effects and/or serious adverse events (SAE). We also noted whether side effects/SAE were considered to be related to the tVNS and the proportion of participants dropping out of studies due to side effects. RESULTS 51 studies were included comprising a total of 1322 human subjects receiving tVNS. The most common side effects were: local skin irritation from electrode placement (240 participants, 18.2%), headache (47, 3.6%) and nasopharyngitis (23, 1.7%). Whilst heterogeneity in overall side effect event rates between studies was not accounted for by the frequency (Hz) or pulse width (ms) of stimulation, a minority (35 participants (2.6%)) dropped out of studies due to side effects. Overall, 30 SAE occurred but only 3 were assessed by the relevant researchers to be possibly caused by tVNS. CONCLUSION tVNS is safe and well tolerated at the doses tested in research studies to date.
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Cites
1 retracted
Steenbergen, L., Sellaro, R., Stock, A., Verkuil, B., Beste, C., & Colzato, L. S. (2015) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2015.03.015 · Cited by 115
RetractedPRISMA harms checklist: improving harms reporting in systematic reviews
Zorzela, L., Loke, Y. K., Ioannidis, J. P., Golder, S., Santaguida, P., Altman, D. G., Moher, D., Vohra, S., & PRISMA harms group (2016) · BMJ · doi:10.1136/bmj.i157 · Cited by 557
Non-invasive Vagus Nerve Stimulation in Healthy Humans Reduces Sympathetic Nerve Activity
Clancy, J. A., Mary, D. A., Witte, K. K., Greenwood, J. P., Deuchars, S. A., & Deuchars, J. (2014) · Brain Stimulation · doi:10.1016/j.brs.2014.07.031 · Cited by 539
Kraus, T., Hösl, K., Kiess, O., Schanze, A., Kornhuber, J., & Forster, C. (2007) · Journal of Neural Transmission · doi:10.1007/s00702-007-0755-z · Cited by 408
Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part III
Yuan, H., & Silberstein, S. D. (2016) · Headache: The Journal of Head and Face Pain · doi:10.1111/head.12649 · Cited by 381
Zhang, Y., Popović, Z. B., Bibevski, S., Fakhry, I., Sica, D. A., Van Wagoner, D. R., & Mazgalev, T. N. (2009) · Circulation: Heart Failure · doi:10.1161/circheartfailure.109.873968 · Cited by 375
Low-Level Transcutaneous Electrical Vagus Nerve Stimulation Suppresses Atrial Fibrillation
Stavrakis, S., Humphrey, M. B., Scherlag, B. J., Hu, Y., Jackman, W. M., Nakagawa, H., Lockwood, D., Lazzara, R., & Po, S. S. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.12.026 · Cited by 334
Straube, A., Ellrich, J., Eren, O., Blum, B., & Ruscheweyh, R. (2015) · The Journal of Headache and Pain · doi:10.1186/s10194-015-0543-3 · Cited by 316
Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II
Yuan, H., & Silberstein, S. D. (2016) · Headache: The Journal of Head and Face Pain · doi:10.1111/head.12650 · Cited by 303
Rong, P., Liu, J., Wang, L., Liu, R., Fang, J., Zhao, J., Zhao, Y., Wang, H., Vangel, M., Sun, S., et al. (2016) · Journal of Affective Disorders · doi:10.1016/j.jad.2016.02.031 · Cited by 297
Cited by
Yap, J. Y. Y., Keatch, C., Lambert, E., Woods, W., Stoddart, P. R., & Kameneva, T. (2020) · Frontiers in Neuroscience · doi:10.3389/fnins.2020.00284 · Cited by 432
Farmer, A. D., Strzelczyk, A., Finisguerra, A., Gourine, A. V., Gharabaghi, A., Hasan, A., Burger, A. M., Jaramillo, A. M., Mertens, A., Majid, A., et al. (2021) · Frontiers in Human Neuroscience · doi:10.3389/fnhum.2020.568051 · Cited by 355
Self-citation
Metadata
- Authors
- Redgrave, J., Day, D., Leung, H., Laud, P. J., Ali, A., Lindert, R., & Majid, A.
- Venue
- Brain Stimulation
- Publisher
- Elsevier BV
- Published
- 2018-11
- Volume
- 11
- Issue
- 6
- Pages
- 1225-1238
- ISSN
- 1876-4754 (ISSN-L)
- 1935-861X
- OpenAlex
- W2888348079
- Cited by
- 320
- References
- 51
- FWCI
- 1.81
- Type
- journal article
- Language
- en
- Open access
- green
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- Redgrave, J., Day, D., Leung, H., Laud, P. J., Ali, A., Lindert, R., & Majid, A. (2018). Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimulation. https://doi.org/10.1016/j.brs.2018.08.010
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