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Draft:Non-Invasive Vagus Nerve Stimulation Devices

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Non-Invasive Vagus Nerve Stimulation Devices

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Non-invasive vagus nerve stimulation (nVNS) devices are emerging technologies designed to stimulate the vagus nerve without surgical implantation. They have been investigated for their potential roles in stress reduction, anxiety management, sleep improvement, and autonomic nervous system regulation.[1]

While interest in these devices has grown, many public resources and reviews are paid advertisements or sponsored content, which may present biased or incomplete information.[2] Peer-reviewed, large-scale clinical studies are limited for many of the commercially available products.

Classifications

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Non-invasive VNS devices can be categorized based on stimulation modality and anatomical target.

Device Type Device Manufacturer Method of Stimulation Primary Target
Cervical Electrical VNS gammaCore ElectroCore Electrical stimulation Cervical vagus nerve
Cervical Electrical VNS TruVaga TruVaga Electrical stimulation Cervical vagus nerve
Cervical Electrical VNS Pulsetto Pulsetto Electrical stimulation Cervical vagus nerve
Cervical Electrical VNS TENS units (adapted) Various Electrical stimulation Variable (cervical region)
Auricular Electrical VNS Alpha-Stim Electromedical Products International Cranial electrotherapy stimulation (CES) Auricular branch of vagus nerve
Auricular Electrical VNS Nurosym Nurosym Electrical stimulation Auricular branch of vagus nerve
Auricular Electrical VNS Parasym Parasym Ltd Electrical stimulation Auricular branch of vagus nerve
Auricular Electrical VNS Xen Neuvana Electrical stimulation paired with audio Auricular branch of vagus nerve
Mechanical Vibration VNS Apollo Neuro Apollo Neuroscience Vibration General vagal pathways
Mechanical Vibration VNS Sensate BioSelf Technology Infrasonic vibration Chest/thoracic stimulation of vagus nerve
Auricular Ultrasound VNS ZenBud NeurGear Low-intensity ultrasound Auricular branch of vagus nerve

Cervical Electrical Vagus Nerve Stimulation

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Cervical electrical VNS devices deliver transcutaneous electrical impulses to the cervical vagus nerve through the neck.

  • ElectroCore (gammaCore): gammaCore is an FDA-cleared handheld device indicated for the acute treatment of migraine and cluster headaches.[3]
  • TruVaga: TruVaga provides a portable cervical stimulator designed to reduce stress and anxiety through vagus nerve activation.[4]
  • Pulsetto: Pulsetto offers a wearable system that claims to promote relaxation and parasympathetic nervous system engagement through vagal stimulation.[5]
  • TENS Devices: Traditional TENS units, typically used for musculoskeletal pain, have been adapted in some contexts to target vagus nerve pathways.[6]

Auricular Electrical Vagus Nerve Stimulation

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Auricular electrical stimulation targets the vagus nerve fibers accessible through the outer ear.

  • Alpha-Stim: Alpha-Stim delivers microcurrents through electrodes clipped to the earlobes and is marketed for treating anxiety, insomnia, and depression.[7]
  • Nurosym: Nurosym is a wearable auricular stimulator claimed to regulate autonomic function through low-level electrical stimulation.[8]
  • Parasym: Parasym offers a transcutaneous auricular VNS device designed to deliver micro-pulses to the tragus area.[9]
  • Xen by Neuvana: Xen integrates music-based relaxation with concurrent auricular electrical stimulation.[10]

Mechanical Vibration Vagus Nerve Stimulation

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Devices using mechanical vibration aim to stimulate vagal pathways indirectly via vibratory signals.

  • Apollo Neuro: Apollo Neuro delivers low-frequency vibrations to various body sites, purportedly activating vagus nerve-related pathways.[11]
  • Sensate: Sensate generates infrasonic vibrations through the chest area, intended to stimulate vagal tone.[12]

Auricular Ultrasound Vagus Nerve Stimulation

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Auricular ultrasound stimulation represents a novel approach using low-intensity sound waves to activate vagus nerve fibers through the outer ear.

  • ZenBud (NeurGear): ZenBud is an auricular ultrasound VNS device designed to deliver focused ultrasound energy non-invasively to the auricular branch of the vagus nerve.[13]

Criticisms and Considerations

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While non-invasive vagus nerve stimulation technologies have expanded in consumer markets, there remains a lack of robust, independent clinical evidence validating many claims.[14] Most consumer-facing reviews and information sources are financially tied to manufacturers, potentially introducing bias.[15]

Healthcare providers recommend cautious evaluation of claims and consultation with medical professionals before beginning nVNS treatments, particularly for individuals with underlying medical or psychiatric conditions.[16]

See Also

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References

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  1. ^ Yap, J.Y.Y. (2020). "Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice". Frontiers in Neuroscience. 14: 284. doi:10.3389/fnins.2020.00284. PMC 7199464. PMID 32410932.
  2. ^ Farmer, A.D. (2020). "International Consensus Based Review and Recommendations for Minimum Reporting Standards in Clinical Studies of transcutaneous Vagus Nerve Stimulation (tVNS)". Brain Stimulation. 13 (3): 688–700. doi:10.1016/j.brs.2020.01.002. PMID 32289677.
  3. ^ "510(k) Summary: gammaCore Sapphire Non-invasive Vagus Nerve Stimulator" (PDF). FDA Premarket Notification Database.
  4. ^ "Evaluation of a Non-invasive Device for Stress and Anxiety Reduction". ClinicalTrials.gov.
  5. ^ Yap, J.Y.Y. (2020). "Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice". Frontiers in Neuroscience. 14: 284. doi:10.3389/fnins.2020.00284. PMC 7199464. PMID 32410932.
  6. ^ Clancy, J.A. (2013). "The wonders of the Wanderer: What has vagus nerve stimulation taught us about autonomic control of inflammation?". The Journal of Physiology. 591 (2): 4085–4096. doi:10.1113/jphysiol.2013.254920. PMC 3779107. PMID 23753525.
  7. ^ Barclay, T.H. (2014). "A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression". Journal of Affective Disorders. 164: 171–177. doi:10.1016/j.jad.2014.05.053. PMID 25069082.
  8. ^ Farmer, A.D. (2020). "International Consensus Based Review and Recommendations for Minimum Reporting Standards in Clinical Studies of transcutaneous Vagus Nerve Stimulation (tVNS)". Brain Stimulation. 13 (3): 688–700. doi:10.1016/j.brs.2020.01.002. PMID 32289677.
  9. ^ Farmer, A.D. (2020). "International Consensus Based Review and Recommendations for Minimum Reporting Standards in Clinical Studies of transcutaneous Vagus Nerve Stimulation (tVNS)". Brain Stimulation. 13 (3): 688–700. doi:10.1016/j.brs.2020.01.002. PMID 32289677.
  10. ^ Farmer, A.D. (2020). "International Consensus Based Review and Recommendations for Minimum Reporting Standards in Clinical Studies of transcutaneous Vagus Nerve Stimulation (tVNS)". Brain Stimulation. 13 (3): 688–700. doi:10.1016/j.brs.2020.01.002. PMID 32289677.
  11. ^ Rabin, D. (2022). "Impact of a Wearable Vibrational Neurotechnology on Heart Rate Variability and Sympathetic Nervous System Activity: Feasibility Study". Frontiers in Psychiatry. 13. doi:10.3389/fpsyt.2022.791518 (inactive 29 April 2025).{{cite journal}}: CS1 maint: DOI inactive as of April 2025 (link)
  12. ^ Yap, J.Y.Y. (2020). "Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice". Frontiers in Neuroscience. 14: 284. doi:10.3389/fnins.2020.00284. PMC 7199464. PMID 32410932.
  13. ^ Hacker, J. (2024). "Non-invasive ultrasound stimulation of the auricular vagus nerve for stress, anxiety, and sleep: Pilot randomized controlled trial". JMIR Preprints.
  14. ^ Yap, J.Y.Y. (2020). "Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice". Frontiers in Neuroscience. 14: 284. doi:10.3389/fnins.2020.00284. PMC 7199464. PMID 32410932.
  15. ^ Farmer, A.D. (2020). "International Consensus Based Review and Recommendations for Minimum Reporting Standards in Clinical Studies of transcutaneous Vagus Nerve Stimulation (tVNS)". Brain Stimulation. 13 (3): 688–700. doi:10.1016/j.brs.2020.01.002. PMID 32289677.
  16. ^ Farmer, A.D. (2020). "International Consensus Based Review and Recommendations for Minimum Reporting Standards in Clinical Studies of transcutaneous Vagus Nerve Stimulation (tVNS)". Brain Stimulation. 13 (3): 688–700. doi:10.1016/j.brs.2020.01.002. PMID 32289677.