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A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms.

作者信息

Badran Bashar W, Huffman Sarah M, Dancy Morgan, Austelle Christopher W, Bikson Marom, Kautz Steven A, George Mark S

机构信息

Medical University of South Carolina.

City College of the City University of New York: The City College of New York.

出版信息

Res Sq. 2022 Jun 21:rs.3.rs-1716096. doi: 10.21203/rs.3.rs-1716096/v1.


DOI:10.21203/rs.3.rs-1716096/v1
PMID:35765566
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9238186/
Abstract

Background Although the coronavirus disease 19 (COVID-19) pandemic has now impacted the world for over two years, the persistent secondary neuropsychiatric effects are still not fully understood. These "long COVID" symptoms, also referred to as post-acute sequelae of SARS-CoV-2 infection (PASC), can persist for months after infection without any effective treatments. Long COVID involves a complex heterogenous symptomology and can lead to disability and limit work. Long COVID symptoms may be due to sustained inflammatory responses and prolonged immune response after infection. Interestingly, vagus nerve stimulation (VNS) may have anti-inflammatory effects, however, until recently, VNS could not be self-administered, at-home, noninvasively. Methods We created a double-blind, noninvasive transcutaneous auricular VNS (taVNS) system that can be self-administered at home with simultaneous remote monitoring of physiological biomarkers and video supervision by study staff. Subsequently, we carried out a pilot (n = 13) randomized, sham-controlled, trial with this system for four weeks to treat nine predefined long covid symptoms (anxiety, depression, vertigo, anosmia, ageusia, headaches, fatigue, irritability, brain fog). No in-person patient contact was needed, with informed consent, trainings, ratings, and all procedures being conducted remotely during the pandemic (2020-2021) and equipment being shipped to individuals' homes. This trial was registered onClinicalTrials.gov under the identifier: NCT04638673. Results Four-weeks of at-home self-administered taVNS (two, one-hour sessions daily, delivered at suprathreshold intensities) was feasible and safe. Although our trial was not powered to determine efficacy as an intervention in a heterogenous population, the trends in the data suggest taVNS may have a mild to moderate effect in reducing mental fatigue symptoms in a subset of individuals. This innovative study demonstrates the safety and feasibility of supervised self-administered taVNS under a fully contactless protocol and suggests that future studies can safely investigate this novel form of brain stimulation at-home for a variety of neuropsychiatric and motor recovery applications.

摘要

相似文献

[1]
A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms.

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本文引用的文献

[1]
Non-invasive Vagus Nerve Stimulation for COVID-19: Results From a Randomized Controlled Trial (SAVIOR I).

Front Neurol. 2022-4-8

[2]
The effect of transcutaneous auricular vagus nerve stimulation on HRV in healthy young people.

PLoS One. 2022

[3]
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS).

Brain Stimul. 2021

[4]
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BMJ. 2021-7-26

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Front Microbiol. 2021-6-23

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Viruses. 2021-4-18

[8]
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Front Hum Neurosci. 2021-3-23

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Signs and symptoms to determine if a patient presenting in primary care or hospital outpatient settings has COVID-19.

Cochrane Database Syst Rev. 2021-2-23

[10]
Applications of Non-invasive Neuromodulation for the Management of Disorders Related to COVID-19.

Front Neurol. 2020-11-25

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