Vagus nerve stimulation

Short description: Medical treatment that involves delivering electrical impulses to the vagus nerve.

Vagus nerve stimulation

Electrical stimulation of vagus nerve.

Other names| Vagal nerve stimulation

[edit on Wikidata]

Vagus nerve stimulation (VNS) is a medical treatment that involves delivering electrical impulses to the vagus nerve. It is used as an add-on treatment for certain types of intractable epilepsy, cluster headaches, treatment-resistant depression and stroke rehabilitation.

## Contents

* 1 Medical use
* 1.1 Epilepsy
* 1.2 Cluster headaches
* 1.3 Treatment-resistant depression
* 1.4 Stroke rehabilitation
* 2 Efficacy
* 2.1 Epilepsy
* 2.2 Depression
* 2.3 Wellbeing
* 2.4 Other possible efficacy areas
* 3 Mechanisms of action
* 3.1 Cortical desynchronization
* 3.2 Reducing inflammation
* 3.3 Changing neurotransmitter activity
* 3.4 Changing brain region connectivity
* 3.5 Impacting the gut-brain axis
* 3.6 Indirect stimulation of brain structures
* 4 Adverse events
* 4.1 Adverse events related to the surgical procedure
* 4.2 Side effects of VNS
* 5 Devices and procedures
* 5.1 Intravenous devices
* 5.1.1 Example of stimulation metrics
* 5.2 External devices
* 6 History
* 6.1 1880s - proposed use to reduce cerebral blood flow
* 6.2 1930s - research on effects on central nervous system
* 6.3 1980s - use for epilepsy
* 6.4 1997 onwards - approved medical uses
* 7 Research areas
* 8 See also
* 9 References
* 10 Further reading

## Medical use

### Epilepsy

VNS is used to treat drug-resistant epilepsy.[1]

In the United States, VNS is approved as adjunctive therapy for those 4 years of age or older with refractory focal onset seizures. In the European Union, VNS is approved as an adjunctive therapy for patients with either generalized or focal onset seizures without any age restrictions.[2] It is recommended that VNS is only pursued following an adequate trial of at least 2 appropriately chosen anti-seizure medications and that the patient is ineligible for epilepsy surgery.[3] This is because epilepsy surgery is associated with a higher probability of resulting in seizure freedom.[4] Patients who have poor adherence or tolerance of anti-seizure medications may be good candidates for VNS.[5]

VNS may provide benefit for particular epilepsy syndromes and seizure types such as Lennox-Gastaut syndrome, tuberous sclerosis complex related epilepsy, refractory absence seizures and atonic seizures.[6][7][8][9] There are also reports of VNS being successfully utilized in patients with refractory and super-refractory status epilepticus.[10]

### Cluster headaches

The UK National Institute for Health and Care Excellence (NICE) in the UK recommends VNS for cluster headaches.[11]

### Treatment-resistant depression

VNS is used to treat treatment-resistant major depressive disorder (TR-MDD). [12] The UK NICE guidance (from 2020) stated that "Evidence on its efficacy is limited in quality." and encouraged further research studies "in the form of randomised controlled trials with a placebo or sham stimulation arm."[13]

### Stroke rehabilitation

In 2021 the U.S. Food and Drug Administration approved the MicroTransponder Vivistim Paired VNS System (Vivistim System) to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke.[14][15]

## Efficacy

### Epilepsy

A meta-analysis of 74 clinical studies with 3321 patients found that VNS produced an average 51% reduction in seizures after 1 year of therapy.[16] Approximately 50% of patients had an equal to or greater than 50% reduction in seizures at the time of last follow-up.[16] Long-term studies have shown that response to VNS increases over time. For instance, a study that followed 74 patients for 10–17 years found a seizure frequency reduction of 50-90% in 38.4%, 51.4%, 63.6% and 77.8% of patients at 1-, 2-, 10- and 17-years following implantation, respectively.[17] Approximately, 8% have total resolution of seizures.[18] VNS has also been shown to reduce rates of sudden unexpected death in epilepsy (SUDEP) and to improve quality of life metrics.[19][20] A number of predictors of a favorable clinical response have been identified including epilepsy onset > 12 years of age, generalized epilepsy type, non-lesional epilepsy, posttraumatic epilepsy and those who have less than a 10-year history of seizures.[16][18][21]

Long-term cognitive outcomes are at least stable following VNS.[22]

One study of children with epilepsy found that a post hoc analysis revealed a dose–response correlation for VNS.[23]

### Depression

A 2022 narrative review concluded that "The use of VNS is an approved, effective and well-tolerated long-term therapy for chronic and treatment-resistant depression. Further sham-controlled studies over a longer observational period are desirable".[24][25] The review also found that, "Many studies and case series demonstrated the efficacy of VNS as an adjuvant procedure for TRD (treatment resistant depression). The effect occurs with a latency period of 3–12 months and possibly increases with the duration of VNS."[26] One study of only 10 weeks found no effect.[27]

A 2020 review concluded "Reviewed studies strongly suggest that VNS ameliorates depressive symptoms in drug-resistant epileptic patients and that the VNS effect on depression is uncorrelated to seizure response.[28]

In one study higher electrical dose parameters were associated with response durability.[29]

### Wellbeing

VNS may have positive wellbeing, mood and quality of life effects.[30][31]

Studies have found improvements in standard patient-reported mood assessment scales in adult patients with epilepsy after using VNS,[32] and some have found no association between mood change and reduction in seizure frequency.[33][34] Another study of epilepsy patients measured a general mood improvement, and suggested that VNS may improve unspecific states of indisposition and dysphoria.[35] Patients with comorbid depression have been found to have mood improvements with VNS therapy.[36]

Quality of life (QOL) improvement was also associated with VNS use.[37] One study of children with epilepsy found that better quality of life outcomes after VNS implantation were strongly associated with shorter duration of preoperative seizures and implantation at a young age.[38]

Anxiety reduction has been associated with VNS use.[39][40][41] Another study showed improvement in anxiety, depression and QOL scores that were not correlated with a reduction in seizure frequency.[42]

However these studies were small, and recommendations have been made that larger studies with randomised control groups be undertaken.[43]

### Other possible efficacy areas

Very small studies have shown possible efficacy of VNS for reduction of Sjogren's fatigue,[44][45] and for bowel inflammatory disease.[46]

## Mechanisms of action

The causes of VNS efficacy are not well understood.

Mechanisms which may account for the efficacy of VNS include:

### Cortical desynchronization

There is evidence that VNS results in cortical desynchronization in epilepsy patients who had a favorable clinical response relative to those who did not.[47][48][49] This makes sense given that seizures consist of abnormal hypersynchronous activity in the brain.

### Reducing inflammation

Multiple lines of evidence suggest that inflammation plays a significant role in epilepsy as well as associated neurobehavioral comorbidities such as depression, autism spectrum disorder and cognitive impairment.[50] There is evidence that VNS has an anti-inflammatory effect through both peripheral and central mechanisms.[51][46]

### Changing neurotransmitter activity

VNS can change the activity of several neurotransmitter systems involving serotonin, norepinephrine and GABA.[52][53] These neurotransmitters are involved in both epilepsy and other neuropsychiatric conditions such as depression and anxiety.

### Changing brain region connectivity

VNS may alter the functional connectivity in several brain regions and enhance synaptic plasticity to reduce excitatory activity involved in seizures.[54][55] It has also been shown to change the functional connectivity of the default mode network in depressed patients.[56]

### Impacting the gut-brain axis

VNS may influence the vagus nerve, which plays a role in the gut-brain axis.[57][58]

### Indirect stimulation of brain structures

Some believe that indirect stimulation of the thalamus may be a key mechanism in VNS efficacy.[59]

## Adverse events

### Adverse events related to the surgical procedure

A large 25-year retrospective study of 247 patients found a surgical complication rate of 8.6%.[60] The common adverse events included infection in 2.6%, hematoma at the surgical site in 1.9% and vocal cord palsy in 1.4%.[60]

### Side effects of VNS

The most common stimulation related side effect at 1 year following implantation are hoarseness in 28% and paraesthesias in the throat-chin region in 12%.[61] At the third year the rate of stimulation related adverse effects decreased substantially with shortness of breath being the most common and occurring in 3.2%.[61] In general, VNS is well tolerated and side effects diminish over time. Also, side effects can be controlled by changing the stimulation parameters.

One small study found sleep apnea in as many as 28% of adults with epilepsy treated with VNS.[62]

Another small study found significant daytime drowsiness, which could be relieved by reducing the stimulation intensity.[42]

A range of side effects are possible but rare.[63]

## Devices and procedures

### Intravenous devices

The device consists of a generator the size of a matchbox that is implanted under the skin below the person's collarbone. Lead wires from the generator are tunnelled up to the patient's neck and wrapped around the left vagus nerve at the carotid sheath, where it delivers electrical impulses to the nerve.[64]

Implantation of the VNS device is usually done as an out-patient procedure. The procedure goes as follows: an incision is made in the upper left chest and the generator is implanted into a little "pouch" on the left chest under the collarbone. A second incision is made in the neck, so that the surgeon can access the vagus nerve. The surgeon then wraps the leads around the left branch of the vagus nerve, and connects the electrodes to the generator. Once successfully implanted, the generator sends electric impulses to the vagus nerve at regular intervals. The left vagus nerve is stimulated rather than the right because the right plays a role in cardiac function such that stimulating it could have negative cardiac effects.[12][65] The "dose" administered by the device then needs to be set, which is done via a magnetic wand; the parameters adjusted include current, frequency, pulse width, and duty cycle.[12]

#### Example of stimulation metrics

The intravenous VNS system produced by LivaNova has stated default settings for use in depression of output power 1.25mA, freqency 20 Hz and pulse width 250µSec, with operation occurring for 30 seconds every 5 minutes (giving a work cycle of 10%).[66]

### External devices

External devices work by transcutaneous stimulation and do not require surgery. Electrical impulses are targeted at the vagus nerve in the neck, or aurical (ear), at points where branches of the vagus nerve have cutaneous representation. GammaCore is recommended by The National Institute for Health and Care Excellence (NICE) for cluster headaches.[67]

## History

### 1880s - proposed use to reduce cerebral blood flow

James L. Corning (1855-1923) was an American neurologist who developed the first device for stimulating the vagus nerve towards the end of the 19th century.[68] At this time a widely held theory was that excessive blood flow caused seizures.[68] In the 1880s Corning designed a pronged instrument called the “carotid fork” to compress the carotid artery for the acute treatment of seizures. In addition, he developed the “carotid truss” for prolonged compression of the carotid arteries as a long-term preventative treatment for epilepsy. Then he developed the “electrocompressor” which allowed for the compression of the bilateral carotid arteries as well as electrical stimulation of both the vagus and cervical sympathetic nerves. The idea was to reduce cardiac output and to stimulate cervical sympathetic nerves to constrict cerebral blood vessels. Corning reported dramatic benefits however it was not accepted by his colleagues and ultimately was forgotten.[68]

### 1930s - research on effects on central nervous system

In the 1930s Biley and Bremer demonstrated the direct influence of VNS on the central nervous system.[69] In the 1940s and 1950s vagal nerve stimulation was shown to affect EEG activity.[70]

### 1980s - use for epilepsy

In 1985 neuroscientist Jacob Zabara[71] proposed that VNS could be used to treat epilepsy.[72] He then demonstrated its efficacy in animal experiments.[73] The first human was implanted with a VNS for the treatment of epilepsy in 1988.[74]

### 1997 onwards - approved medical uses

In 1997, the US Food and Drug Administration's neurological devices panel met to consider approval of an implanted vagus nerve stimulator (VNS) for epilepsy, requested by Cyberonics (which was subsequently acquired by LivaNova).[64]

The FDA approved an implanted VNS for TR-MDD in 2005.[12]

In April 2017, the FDA cleared marketing of a handheld noninvasive vagus nerve stimulator, called "gammaCore" and made by ElectroCore LLC, for episodic cluster headaches, under the de novo pathway.[75][76] In January 2018, the FDA cleared a new use of that device, for the treatment of migraine pain in adults under a 510(k) based on the de novo clearance.[77][78]

In 2020, electroCore's non-invasive VNS was granted an Emergency Use Authorization for treating COVID-19 patients, given Research has shown this pulse train causes airways in the lungs to open its anti-inflammatory effect.[79]

## Research areas

Because the vagus nerve is associated with many different functions and brain regions, clinical research has been done to determine its usefulness in treating many illnesses. These include various anxiety disorders,[80] obesity,[81][82] alcohol addiction,[83] chronic heart failure,[84] prevention of arrhythmias that can cause sudden cardiac death,[85] autoimmune disorders,[86][87] irritable bowel syndrome,[88][89][90] Alzheimer's disease,[91][92] Parkinson's disease,[93] hypertension,[94][95] several chronic pain conditions,[96] inflammatory disorders, fibromyalgia and migraines.[97][98]

A 2022 study showed that chronic VNS showed strong antidepressant and anxiolytic effects, and improved memory performance in an Alzheimer's Disease animal model.[99]

## See also

* Cranial electrotherapy stimulation
* Deep brain stimulation
* Electrical brain stimulation
* Electrotherapy
* Low field magnetic stimulation
* Transcranial magnetic stimulation

## References

1. ↑ Panebianco, Mariangela; Rigby, Alexandra; Marson, Anthony G. (2022-07-14). "Vagus nerve stimulation for focal seizures". The Cochrane Database of Systematic Reviews 2022 (7): CD002896. doi:10.1002/14651858.CD002896.pub3. ISSN 1469-493X. PMID 35833911.
2. ↑ Wheless, James W.; Gienapp, Andrew J.; Ryvlin, Phillippe (2018-11-01). "Vagus nerve stimulation (VNS) therapy update" (in English). Epilepsy & Behavior 88: 2–10. doi:10.1016/j.yebeh.2018.06.032. ISSN 1525-5050. PMID 30017839. https://www.epilepsybehavior.com/article/S1525-5050(18)30487-6/abstract.
3. ↑ Morris, G. L.; Gloss, D.; Buchhalter, J.; Mack, K. J.; Nickels, K.; Harden, C. (2013-08-28). "Evidence-based guideline update: Vagus nerve stimulation for the treatment of epilepsy: Report of the Guideline Development Subcommittee of the American Academy of Neurology". Neurology 81 (16): 1453–1459. doi:10.1212/wnl.0b013e3182a393d1. ISSN 0028-3878. PMID 23986299.
4. ↑ Fisher, R. S.; Handforth, A. (1999-09-11). "Reassessment: vagus nerve stimulation for epilepsy: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology". Neurology 53 (4): 666–669. doi:10.1212/wnl.53.4.666. ISSN 0028-3878. PMID 10489023.
5. ↑ Helmers, Sandra L.; Duh, Mei Sheng; Guérin, Annie; Sarda, Sujata P.; Samuelson, Thomas M.; Bunker, Mark T.; Olin, Bryan D.; Jackson, Stanley D. et al. (2011-10-01). "Clinical and economic impact of vagus nerve stimulation therapy in patients with drug-resistant epilepsy". Epilepsy & Behavior 22 (2): 370–375. doi:10.1016/j.yebeh.2011.07.020. ISSN 1525-5069. PMID 21872534.
6. ↑ Grioni, Daniele; Landi, Andrea (2019-01-01). "Does Vagal Nerve Stimulation Treat Drug-Resistant Epilepsy in Patients with Tuberous Sclerosis Complex?". World Neurosurgery 121: 251–253. doi:10.1016/j.wneu.2018.10.077. ISSN 1878-8750. PMID 30347295.
7. ↑ Braakman, Hilde M.; Creemers, Joke; Hilkman, Danny M.; Klinkenberg, Sylvia; Koudijs, Suzanne M.; Debeij-van Hall, Mariette; Cornips, Erwin M. (2018). "Improved seizure control and regaining cognitive milestones after vagus nerve stimulation revision surgery in Lennox–Gastaut syndrome". Epilepsy & Behavior Case Reports 10: 111–113. doi:10.1016/j.ebcr.2018.08.002. ISSN 2213-3232. PMID 30364578.
8. ↑ Arya, Ravindra; Greiner, Hansel M.; Lewis, Amanda; Mangano, Francesco T.; Gonsalves, Cornelia; Holland, Katherine D.; Glauser, Tracy A. (2013-05-01). "Vagus nerve stimulation for medically refractory absence epilepsy". Seizure 22 (4): 267–270. doi:10.1016/j.seizure.2013.01.008. ISSN 1059-1311. PMID 23391567.
9. ↑ Rolston, John D.; Englot, Dario J.; Wang, Doris D.; Garcia, Paul A.; Chang, Edward F. (2015-10-01). "Corpus callosotomy versus vagus nerve stimulation for atonic seizures and drop attacks: A systematic review". Epilepsy & Behavior 51: 13–17. doi:10.1016/j.yebeh.2015.06.001. ISSN 1525-5050. PMID 26247311.
10. ↑ Dibué-Adjei, Maxine; Brigo, Francesco; Yamamoto, Takamichi; Vonck, Kristl; Trinka, Eugen (2019-09-01). "Vagus nerve stimulation in refractory and super-refractory status epilepticus – A systematic review" (in English). Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation 12 (5): 1101–1110. doi:10.1016/j.brs.2019.05.011. ISSN 1935-861X. PMID 31126871. https://www.brainstimjrnl.com/article/S1935-861X(19)30218-9/abstract.
11. ↑ https://www.nice.org.uk/guidance/mtg46/documents/final-scope The Nurosym/Parasym device was used in these studies; https://www.sciencedirect.com/science/article/pii/S1094715922012636 , https://www.medrxiv.org/content/10.1101/2022.11.08.22281807v1
12. ↑ 12.0 12.1 12.2 12.3 "Vagal Nerve Stimulation for Treatment-Resistant Depression". Neurotherapeutics 14 (3): 716–727. July 2017. doi:10.1007/s13311-017-0537-8. PMID 28585221.
13. ↑ "1 Recommendations | Implanted vagus nerve stimulation for treatment-resistant depression | Guidance | NICE". 12 August 2020. https://www.nice.org.uk/guidance/ipg679/chapter/1-Recommendations.
14. ↑ "FDA Approves First-of-Its-Kind Stroke Rehabilitation System". 31 August 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-stroke-rehabilitation-system#:~:text=“Today's approval of the Vivistim,limbs due to ischemic stroke.”.
15. ↑ Liu, Charles Y.; Russin, Jonathan; Adelson, David P.; Jenkins, Alistair; Hilmi, Omar; Brown, Benjamin; Lega, Bradley; Whitworth, Tony et al. (2022). "Vagus nerve stimulation paired with rehabilitation for stroke: Implantation experience from the VNS-REHAB trial". Journal of Clinical Neuroscience 105: 122–128. doi:10.1016/j.jocn.2022.09.013. PMID 36182812. https://www.sciencedirect.com/science/article/abs/pii/S0967586822003745.
16. ↑ 16.0 16.1 16.2 Englot, Dario J.; Chang, Edward F.; Auguste, Kurtis I. (2011-12-01). "Vagus nerve stimulation for epilepsy: a meta-analysis of efficacy and predictors of response". Journal of Neurosurgery 115 (6): 1248–1255. doi:10.3171/2011.7.JNS11977. ISSN 1933-0693. PMID 21838505.
17. ↑ Chrastina, Jan; Novák, Zdeněk; Zeman, Tomáš; Kočvarová, Jitka; Pail, Martin; Doležalová, Irena; Jarkovský, Jiří; Brázdil, Milan (2018-07-01). "Single-center long-term results of vagus nerve stimulation for epilepsy: A 10–17 year follow-up study". Seizure 59: 41–47. doi:10.1016/j.seizure.2018.04.022. ISSN 1059-1311. PMID 29738985.
18. ↑ 18.0 18.1 Englot, Dario J.; Rolston, John D.; Wright, Clinton W.; Hassnain, Kevin H.; Chang, Edward F. (2016-09-01). "Rates and Predictors of Seizure Freedom With Vagus Nerve Stimulation for Intractable Epilepsy". Neurosurgery 79 (3): 345–353. doi:10.1227/NEU.0000000000001165. ISSN 1524-4040. PMID 26645965.
19. ↑ Englot, Dario J.; Hassnain, Kevin H.; Rolston, John D.; Harward, Stephen C.; Sinha, Saurabh R.; Haglund, Michael M. (2017-01-01). "Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data". Epilepsy & Behavior 66: 4–9. doi:10.1016/j.yebeh.2016.10.005. ISSN 1525-5050. PMID 27974275.
20. ↑ Ryvlin, Philippe; So, Elson L.; Gordon, Charles M.; Hesdorffer, Dale C.; Sperling, Michael R.; Devinsky, Orrin; Bunker, Mark T.; Olin, Bryan et al. (2018-01-16). "Long-term surveillance of SUDEP in drug-resistant epilepsy patients treated with VNS therapy". Epilepsia 59 (3): 562–572. doi:10.1111/epi.14002. ISSN 0013-9580. PMID 29336017.
21. ↑ Englot, Dario J.; Rolston, John D.; Wang, Doris D.; Hassnain, Kevin H.; Gordon, Charles M.; Chang, Edward F. (2012-09-14). "Efficacy of vagus nerve stimulation in posttraumatic versus nontraumatic epilepsy". Journal of Neurosurgery 117 (5): 970–977. doi:10.3171/2012.8.jns122. ISSN 0022-3085. PMID 22978542.
22. ↑ Lam, Jordan; Williams, Marcus; Ashla, Mark; Lee, Darrin J. (2021). "Cognitive outcomes following vagus nerve stimulation, responsive neurostimulation and deep brain stimulation for epilepsy: A systematic review". Epilepsy Research 172. doi:10.1016/j.eplepsyres.2021.106591. PMID 33711711. https://www.sciencedirect.com/science/article/abs/pii/S0920121121000449.
23. ↑ Orosz, Iren; McCormick, David; Zamponi, Nelia; Varadkar, Sophia; Feucht, Martha; Parain, Dominique; Griens, Roger; Vallée, Louis et al. (2014). "Vagus nerve stimulation for drug-resistant epilepsy: A European long-term study up to 24 months in 347 children". Epilepsia 55 (10): 1576–1584. doi:10.1111/epi.12762. PMID 25231724.
24. ↑ Reif-Leonhard, C.; Reif, A.; Baune, B. T.; Kavakbasi, E. (5 April 2022). "Vagusnervstimulation bei schwer zu behandelnden Depressionen" (in de). Der Nervenarzt (Springer Science and Business Media LLC) 93 (9): 921–930. doi:10.1007/s00115-022-01282-6. ISSN 0028-2804. PMID 35380222.
25. ↑ Kron, Thomas (5 May 2022). "Vagus Nerve Stimulation: A Little-Known Option for Depression". https://www.medscape.com/viewarticle/973508?uac=88149SY&faf=1&sso=true&impID=4234975&src=mkm_ret_220511_mscpmrk_icymi-ous_int.
26. ↑ Reif-Leonhard, C.; Reif, A.; Baune, B. T.; Kavakbasi, E. (2022). "Vagusnervstimulation bei schwer zu behandelnden Depressionen". Der Nervenarzt 93 (9): 921–930. doi:10.1007/s00115-022-01282-6. PMID 35380222.
27. ↑ Rush, A. J.; Marangell, L. B.; Sackeim, H. A.; George, M. S.; Brannan, S. K.; Davis, S. M.; Howland, R.; Kling, M. A. et al. (2005). "Vagus nerve stimulation for treatment-resistant depression: A randomized, controlled acute phase trial". Biological Psychiatry 58 (5): 347–354. doi:10.1016/j.biopsych.2005.05.025. PMID 16139580. https://pubmed.ncbi.nlm.nih.gov/16139580/.
28. ↑ Assenza, Giovanni; Tombini, Mario; Lanzone, Jacopo; Ricci, Lorenzo; Di Lazzaro, Vincenzo; Casciato, Sara; Morano, Alessandra; Giallonardo, Anna Teresa et al. (2020-11-01). "Antidepressant effect of vagal nerve stimulation in epilepsy patients: a systematic review" (in en). Neurological Sciences 41 (11): 3075–3084. doi:10.1007/s10072-020-04479-2. ISSN 1590-3478. PMID 32524324. https://doi.org/10.1007/s10072-020-04479-2.
29. ↑ Aaronson, S. T.; Carpenter, L. L.; Conway, C. R.; Reimherr, F. W.; Lisanby, S. H.; Schwartz, T. L.; Moreno, F. A.; Dunner, D. L. et al. (2013). "Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: Acute and chronic effects". Brain Stimulation 6 (4): 631–640. doi:10.1016/j.brs.2012.09.013. PMID 23122916. https://pubmed.ncbi.nlm.nih.gov/23122916/.
30. ↑ Arredondo, Kristen; Patel, Anup D. (2023). "Quality of life, neurocognitive outcomes, and mood effects with neurostimulation devices". Neurostimulation for Epilepsy. pp. 229–244. doi:10.1016/B978-0-323-91702-5.00004-9. ISBN 9780323917025. https://www.sciencedirect.com/science/article/abs/pii/B9780323917025000049.
31. ↑ https://www.epilepsybehavior.com/article/S1525-5050(03)00320-2/fulltext
32. ↑ Morris, G. L.; Gloss, D.; Buchhalter, J.; Mack, K. J.; Nickels, K.; Harden, C. (2013). "Evidence-based guideline update: Vagus nerve stimulation for the treatment of epilepsy: Report of the Guideline Development Subcommittee of the American Academy of Neurology". Neurology 81 (16): 1453–1459. doi:10.1212/WNL.0b013e3182a393d1. PMID 23986299. PMC 3806910. https://n.neurology.org/content/81/16/1453.
33. ↑ Elger, G.; Hoppe, C.; Falkai, P.; Rush, A. J.; Elger, C. E. (2000). "Vagus nerve stimulation is associated with mood improvements in epilepsy patients". Epilepsy Research 42 (2–3): 203–210. doi:10.1016/s0920-1211(00)00181-9. PMID 11074193. https://pubmed.ncbi.nlm.nih.gov/11074193/?dopt=Abstract.
34. ↑ Harden, C. L.; Pulver, M. C.; Ravdin, L. D.; Nikolov, B.; Halper, J. P.; Labar, D. R. (2000). "A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation". Epilepsy & Behavior 1 (2): 93–99. doi:10.1006/ebeh.2000.0046. PMID 12609137. https://pubmed.ncbi.nlm.nih.gov/12609137/?dopt=Abstract.
35. ↑ Hoppe, Christian; Helmstaedter, Christoph; Scherrmann, Judith; Elger, Christian E. (2001). "Self-Reported Mood Changes following 6 Months of Vagus Nerve Stimulation in Epilepsy Patients". Epilepsy & Behavior 2 (4): 335–342. doi:10.1006/ebeh.2001.0194. PMID 12609210. https://www.sciencedirect.com/science/article/abs/pii/S1525505001901945.
36. ↑ Fan, Jing-Jing; Shan, Wei; Wu, Jian-Ping; Wang, Qun (2019-08-19). "Research progress of vagus nerve stimulation in the treatment of epilepsy". CNS Neuroscience & Therapeutics 25 (11): 1222–1228. doi:10.1111/cns.13209. ISSN 1755-5949. PMID 31429206.
37. ↑ Ryvlin, Philippe; Gilliam, Frank G.; Nguyen, Dang K.; Colicchio, Gabriella; Iudice, Alfonso; Tinuper, Paolo; Zamponi, Nelia; Aguglia, Umberto et al. (2014). "The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: The PuLsE (Open Prospective Randomized Long-term Effectiveness) trial". Epilepsia 55 (6): 893–900. doi:10.1111/epi.12611. PMID 24754318.
38. ↑ Knorr, Corine; Greuter, Ladina; Constantini, Shlomi; Fried, Itzhak; Kremer, Uri; Datta, Alexandre N.; Guzman, Raphael; Soleman, Jehuda (2021). "Subgroup analysis of seizure and cognitive outcome after vagal nerve stimulator implantation in children". Child's Nervous System 37 (1): 243–252. doi:10.1007/s00381-020-04628-0. PMID 32361930.
39. ↑ George, M. S.; Ward Jr, H. E.; Ninan, P. T.; Pollack, M.; Nahas, Z.; Anderson, B.; Kose, S.; Howland, R. H. et al. (2008). "A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders". Brain Stimulation 1 (2): 112–121. doi:10.1016/j.brs.2008.02.001. PMID 20633378. https://pubmed.ncbi.nlm.nih.gov/20633378/.
40. ↑ Peña, David Frausto; Childs, Jessica E.; Willett, Shawn; Vital, Analicia; McIntyre, Christa K.; Kroener, Sven (2014). "Vagus nerve stimulation enhances extinction of conditioned fear and modulates plasticity in the pathway from the ventromedial prefrontal cortex to the amygdala". Frontiers in Behavioral Neuroscience 8: 327. doi:10.3389/fnbeh.2014.00327. PMID 25278857.
41. ↑ Breit, Sigrid; Kupferberg, Aleksandra; Rogler, Gerhard; Hasler, Gregor (2018). "Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders". Frontiers in Psychiatry 9: 44. doi:10.3389/fpsyt.2018.00044. PMID 29593576.
42. ↑ 42.0 42.1 "A controlled trial of transcutaneous vagus nerve stimulation for the treatment of pharmacoresistant epilepsy". Epilepsy Behav 39: 105–10. October 2014. doi:10.1016/j.yebeh.2014.08.005. PMID 25240121.
43. ↑ https://www.seizure-journal.com/article/S1059-1311(12)00274-9/fulltext
44. ↑ Tarn, Jessica; Evans, Evelyn; Traianos, Emmanuella; Collins, Alexis; Stylianou, Mryto; Parikh, Jehill; Bai, Yang; Guan, Yu et al. (2023). "The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue in Participants with Primary Sjögren's Syndrome". Neuromodulation: Technology at the Neural Interface 26 (3): 681–689. doi:10.1016/j.neurom.2022.08.461. PMID 37032583.
45. ↑ Inflammation has been associated with both fatigue (see the Wikipedia article on fatigue) and possible VNS mechanism (see below).
46. ↑ 46.0 46.1 Sahn, Benjamin; Pascuma, Kristine; Kohn, Nina; Tracey, Kevin J.; Markowitz, James F. (2023). "Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: A proof-of-concept clinical trial". Bioelectronic Medicine 9 (1): 23. doi:10.1186/s42234-023-00124-3. PMID 37849000.
47. ↑ Fraschini, Matteo; Puligheddu, Monica; Demuru, Matteo; Polizzi, Lorenzo; Maleci, Alberto; Tamburini, Giorgio; Congia, Socrate; Bortolato, Marco et al. (2013-03-01). "VNS induced desynchronization in gamma bands correlates with positive clinical outcome in temporal lobe pharmacoresistant epilepsy". Neuroscience Letters 536: 14–18. doi:10.1016/j.neulet.2012.12.044. ISSN 0304-3940. PMID 23333601.
48. ↑ Sangare, Aude; Marchi, Angela; Pruvost-Robieux, Estelle; Soufflet, Christine; Crepon, Benoit; Ramdani, Céline; Chassoux, Francine; Turak, Baris et al. (2020-12-01). "The Effectiveness of Vagus Nerve Stimulation in Drug-Resistant Epilepsy Correlates with Vagus Nerve Stimulation-Induced Electroencephalography Desynchronization". Brain Connectivity 10 (10): 566–577. doi:10.1089/brain.2020.0798. ISSN 2158-0014. PMID 33073582.
49. ↑ Joseph, Navya Mary; Steffan, Paul; Becker, Danielle; Wernovsky, Magda; Datta, Proleta; Ernst, Lia (2022-05-27). "Effects of VNS stimulation on electrocorticography in patients with dual neuro- stimulation devices". Journal of Neurology, Neurosurgery & Psychiatry 93 (6): A3.3–A4. doi:10.1136/jnnp-2022-abn.9. ISSN 0022-3050.
50. ↑ Paudel, Yam Nath; Shaikh, Mohd. Farooq; Shah, Sadia; Kumari, Yatinesh; Othman, Iekhsan (2018-10-15). "Role of inflammation in epilepsy and neurobehavioral comorbidities: Implication for therapy". European Journal of Pharmacology 837: 145–155. doi:10.1016/j.ejphar.2018.08.020. ISSN 0014-2999. PMID 30125565.
51. ↑ Wang, Yue; Zhan, Gaofeng; Cai, Ziwen; Jiao, Bo; Zhao, Yilin; Li, Shiyong; Luo, Ailin (2021-08-01). "Vagus nerve stimulation in brain diseases: Therapeutic applications and biological mechanisms". Neuroscience & Biobehavioral Reviews 127: 37–53. doi:10.1016/j.neubiorev.2021.04.018. ISSN 0149-7634. PMID 33894241.
52. ↑ Manta, Stella; El Mansari, Mostafa; Debonnel, Guy; Blier, Pierre (2012-04-17). "Electrophysiological and neurochemical effects of long-term vagus nerve stimulation on the rat monoaminergic systems". International Journal of Neuropsychopharmacology 16 (2): 459–470. doi:10.1017/s1461145712000387. ISSN 1469-5111. PMID 22717062.
53. ↑ Furmaga, Havan; Shah, Aparna; Frazer, Alan (2011-11-15). "Serotonergic and noradrenergic pathways are required for the anxiolytic-like and antidepressant-like behavioral effects of repeated vagal nerve stimulation in rats". Biological Psychiatry 70 (10): 937–945. doi:10.1016/j.biopsych.2011.07.020. ISSN 1873-2402. PMID 21907323.
54. ↑ Alexander, Georgia M.; Huang, Yang Zhong; Soderblom, Erik J.; He, Xiao-Ping; Moseley, M. Arthur; McNamara, James O. (2016-12-14). "Vagal nerve stimulation modifies neuronal activity and the proteome of excitatory synapses of amygdala/piriform cortex". Journal of Neurochemistry 140 (4): 629–644. doi:10.1111/jnc.13931. ISSN 0022-3042. PMID 27973753.
55. ↑ Zhu, Jin; Xu, Cuiping; Zhang, Xi; Qiao, Liang; Wang, Xueyuan; Zhang, Xiaohua; Yan, Xiaoming; Ni, Duanyu et al. (2020-08-17). "A resting-state functional MRI study on the effect of vagal nerve stimulation on spontaneous regional brain activity in drug-resistant epilepsy patients". Behavioural Brain Research 392: 112709. doi:10.1016/j.bbr.2020.112709. ISSN 0166-4328. PMID 32479850.
56. ↑ Fang, Jiliang; Rong, Peijing; Hong, Yang; Fan, Yangyang; Liu, Jun; Wang, Honghong; Zhang, Guolei; Chen, Xiaoyan et al. (2016-02-15). "Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder". Biological Psychiatry 79 (4): 266–273. doi:10.1016/j.biopsych.2015.03.025. ISSN 0006-3223. PMID 25963932.
57. ↑ Breit, S.; Kupferberg, A.; Rogler, G.; Hasler, G. (2018). "Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders". Frontiers in Psychiatry 9: 44. doi:10.3389/fpsyt.2018.00044. PMID 29593576.
58. ↑ https://www.sciencedirect.com/science/article/pii/S1094715922012636 "Directly after device use, fatigue levels correlate with measures of alpha reactivity, suggesting modulation of cholinergic system integrity as a mechanism of action for nVNS."
59. ↑ "The exact mechanism of [VNS] action is not fully known; however, several theories of its effect on seizures have been proposed. Indirect stimulation of the thalamus likely occurs which may also impact cognition and mood, which can both impact quality of life." 2023. https://www.sciencedirect.com/science/article/abs/pii/B9780323917025000049
60. ↑ 60.0 60.1 Révész, David; Rydenhag, Bertil; Ben-Menachem, Elinor (2016-07-01). "Complications and safety of vagus nerve stimulation: 25 years of experience at a single center". Journal of Neurosurgery: Pediatrics 18 (1): 97–104. doi:10.3171/2016.1.peds15534. ISSN 1933-0707. PMID 27015521.
61. ↑ 61.0 61.1 Coughlin, Maryanne K. (2001-10-01). "Long-Term Treatment with Vagus Nerve Stimulation in Patients with Refractory Epilepsy". AORN Journal 74 (4): 554. doi:10.1016/s0001-2092(06)61692-x. ISSN 0001-2092.
62. ↑ Salvadé, Aude; Ryvlin, Philippe; Rossetti, Andrea O. (2018-02-01). "Impact of vagus nerve stimulation on sleep-related breathing disorders in adults with epilepsy". Epilepsy & Behavior 79: 126–129. doi:10.1016/j.yebeh.2017.10.040. ISSN 1525-5050. PMID 29287215. https://serval.unil.ch/notice/serval:BIB_A91CA09B347D.
63. ↑ "The most common side effect of VNS associated with stimulation is hoarseness, which occurs in about 60% of patients and is still noticed in about half of patients during stimulation 12 months postoperatively [ 32 ] . Other typical side effects in the 12-month follow-up include dyspnea (30%), pain (28%), cough (26%), paraesthesia (23%), headache (22%), dysphagia (16%) and Sleep disorders (11%; [ 33 ]). Other side effects may include laryngism, sore throat and neck, hypertension, nausea and pharyngitis [ 31 ]. By reducing the stimulation intensity or lowering the stimulation frequency or pulse width, the stimulation-associated side effects can be alleviated or even eliminated. A further minor surgical procedure may be necessary due to broken cables or to replace the battery, which has a lifespan of 3 to 8 years depending on the setting of the stimulation parameters [ 31 ] ." https://link.springer.com/article/10.1007/s00115-022-01282-6
64. ↑ 64.0 64.1 "Neurostimulation Devices for the Treatment of Neurologic Disorders". Mayo Clinic Proceedings 92 (9): 1427–1444. September 2017. doi:10.1016/j.mayocp.2017.05.005. PMID 28870357.
65. ↑ "Vagus nerve stimulation: Surgical technique of implantation and revision and related morbidity". Epilepsia 58 (Suppl 1): 85–90. April 2017. doi:10.1111/epi.13678. PMID 28386925.
66. ↑ https://link.springer.com/article/10.1007/s00115-022-01282-6/figures/3 , Diagram 3 in https://link.springer.com/article/10.1007/s00115-022-01282-6
67. ↑ https://www.nice.org.uk/guidance/mtg46/documents/final-scope
68. ↑ 68.0 68.1 68.2 Lanska, D. J. (2002-02-12). "J.L. Corning and vagal nerve stimulation for seizures in the 1880s". Neurology 58 (3): 452–459. doi:10.1212/wnl.58.3.452. ISSN 0028-3878. PMID 11839848.
69. ↑ Bailey, Percival; Bremer, Frédéric (1938-09-01). "A Sensory Cortical Representation of the Vagus Nerve: With a Note on the Effects of Low Blood Pressure on the Cortical Electrogram". Journal of Neurophysiology 1 (5): 405–412. doi:10.1152/jn.1938.1.5.405. ISSN 0022-3077.
70. ↑ George, M. S.; Sackeim, H. A.; Rush, A. J.; Marangell, L. B.; Nahas, Z.; Husain, M. M.; Lisanby, S.; Burt, T. et al. (2000-02-15). "Vagus nerve stimulation: a new tool for brain research and therapy". Biological Psychiatry 47 (4): 287–295. doi:10.1016/s0006-3223(99)00308-x. ISSN 0006-3223. PMID 10686263.
71. ↑ https://www.washingtonpost.com/wp-srv/national/health/daily/march98/epilepsy.htm
72. ↑ Zabara, J. (1985-09-01). "Peripheral control of hypersynchronous discharge in epilepsy". Electroencephalography and Clinical Neurophysiology 61 (3): S162. doi:10.1016/0013-4694(85)90626-1. ISSN 0013-4694.
73. ↑ Zabara, Jacob (1992-11-01). "Inhibition of Experimental Seizures in Canines by Repetitive Vagal Stimulation". Epilepsia 33 (6): 1005–1012. doi:10.1111/j.1528-1157.1992.tb01751.x. ISSN 0013-9580. PMID 1464256.
74. ↑ Penry, J. Kiffin; Dean, J. Christine (1990-06-01). "Prevention of Intractable Partial Seizures by Intermittent Vagal Stimulation in Humans: Preliminary Results". Epilepsia 31 (s2): S40–S43. doi:10.1111/j.1528-1157.1990.tb05848.x. ISSN 0013-9580. PMID 2121469.
75. ↑ "FDA Approves Vagus Nerve Stimulation Device for Cluster Headache". Medscape. April 18, 2017. https://www.medscape.com/viewarticle/878763.
76. ↑ "GammaCore Device Classification under Section 513(f)(2)(de novo)". FDA. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN150048.
77. ↑ "FDA Clears Vagus Nerve Stimulator for Migraine Pain". Medscape. January 29, 2018. https://www.medscape.com/viewarticle/891930.
78. ↑ "GammaCore 510(k) Premarket Notification". FDA. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173442.
79. ↑ "Handheld Vagus Nerve Stimulator Gets Emergency Approval for COVID-19 Use" (in en). 2020-07-22. https://spectrum.ieee.org/handheld-vagus-nerve-stimulator-gets-emergency-approval-for-covid19-use.
80. ↑ "Vagal nerve stimulation: a review of its applications and potential mechanisms that mediate its clinical effects". Neuroscience and Biobehavioral Reviews 29 (3): 493–500. May 2005. doi:10.1016/j.neubiorev.2005.01.004. PMID 15820552.
81. ↑ "Role of the vagus nerve in the development and treatment of diet-induced obesity". The Journal of Physiology 594 (20): 5791–5815. October 2016. doi:10.1113/JP271538. PMID 26959077.
82. ↑ "Brain stimulation in obesity". International Journal of Obesity 41 (12): 1721–1727. December 2017. doi:10.1038/ijo.2017.150. PMID 28663570.
83. ↑ "The current perspective of neuromodulation techniques in the treatment of alcohol addiction: a systematic review". Psychiatria Danubina 24 (Suppl 1): S14–S20. September 2012. PMID 22945180. http://www.hdbp.org/psychiatria_danubina/pdf/dnb_vol24 Suppl 1_no/dnb_vol24 Suppl 1_no_S14.pdf. Retrieved 2014-08-30.
84. ↑ "Devices in the management of advanced, chronic heart failure". Nature Reviews. Cardiology 10 (2): 98–110. February 2013. doi:10.1038/nrcardio.2012.178. PMID 23229137.
85. ↑ "Electrical vagus nerve stimulation for the treatment of chronic heart failure". Cleveland Clinic Journal of Medicine 78 (8 suppl 1): S24–S29. August 2011. doi:10.3949/ccjm.78.s1.04. PMID 21972326.
86. ↑ Can Zapping the Vagus Nerve Jump-Start Immunity?: An experimental procedure is exposing links between nervous and immune systems, Scientific American, 4 May 2017, https://www.scientificamerican.com/article/can-zapping-the-vagus-nerve-jump-start-immunity/
87. ↑ "Balancing the autonomic nervous system to reduce inflammation in rheumatoid arthritis". Journal of Internal Medicine 282 (1): 64–75. July 2017. doi:10.1111/joim.12626. PMID 28547815.
88. ↑ "Therapeutic Potential of Vagus Nerve Stimulation for Inflammatory Bowel Diseases". Frontiers in Neuroscience 15: 650971. 2021. doi:10.3389/fnins.2021.650971. PMID 33828455.
89. ↑ "Anti-inflammatory Effects of Abdominal Vagus Nerve Stimulation on Experimental Intestinal Inflammation". Frontiers in Neuroscience 13: 418. 2019. doi:10.3389/fnins.2019.00418. PMID 31133776.
90. ↑ "Non-Invasive Nerve Stimulation Shows Promise for Younger IBD Patients" (in en). 2021-12-15. https://www.medpagetoday.com/meetingcoverage/aibd/96225.
91. ↑ Merrill, Charley A.; Jonsson, Michael A. G.; Minthon, Lennart; Ejnell, Hasse; C-son Silander, Hans; Blennow, Kaj; Karlsson, Mats; Nordlund, Arto et al. (2006-08-01). "Vagus nerve stimulation in patients with Alzheimer's disease: Additional follow-up results of a pilot study through 1 year". The Journal of Clinical Psychiatry 67 (8): 1171–1178. doi:10.4088/jcp.v67n0801. ISSN 0160-6689. PMID 16965193.
92. ↑ Broncel, A.; Bocian, R.; Kłos-Wojtczak, P.; Kulbat-Warycha, K.; Konopacki, J. (2020-02-01). "Vagal nerve stimulation as a promising tool in the improvement of cognitive disorders" (in en). Brain Research Bulletin 155: 37–47. doi:10.1016/j.brainresbull.2019.11.011. ISSN 0361-9230. PMID 31790720. https://www.sciencedirect.com/science/article/pii/S0361923019308135.
93. ↑ "Noninvasive Vagus Nerve Stimulation for Parkinson Disease Shows Safety, Efficacy" (in en). 3 June 2021. https://www.neurologylive.com/view/noninvasive-vagus-nerve-stimulation-parkinson-shows-safety-efficacy.
94. ↑ Gierthmuehlen, Mortimer; Plachta, Dennis T. T. (2016-02-01). "Effect of selective vagal nerve stimulation on blood pressure, heart rate and respiratory rate in rats under metoprolol medication". Hypertension Research 39 (2): 79–87. doi:10.1038/hr.2015.122. ISSN 1348-4214. PMID 26581776.
95. ↑ Annoni, Elizabeth M.; Van Helden, Dusty; Guo, Yugene; Levac, Brett; Libbus, Imad; KenKnight, Bruce H.; Osborn, John W.; Tolkacheva, Elena G. (2019). "Chronic Low-Level Vagus Nerve Stimulation Improves Long-Term Survival in Salt-Sensitive Hypertensive Rats". Frontiers in Physiology 10: 25. doi:10.3389/fphys.2019.00025. ISSN 1664-042X. PMID 30766489.
96. ↑ "Review of the Uses of Vagal Nerve Stimulation in Chronic Pain Management". Current Pain and Headache Reports 19 (12): 54. December 2015. doi:10.1007/s11916-015-0528-6. PMID 26493698.
97. ↑ "A review of vagus nerve stimulation as a therapeutic intervention". Journal of Inflammation Research 11: 203–213. 2018. doi:10.2147/JIR.S163248. PMID 29844694.
98. ↑ "An Update on Non-Pharmacological Neuromodulation for the Acute and Preventive Treatment of Migraine". Headache 57 (4): 685–691. April 2017. doi:10.1111/head.13069. PMID 28295242.
99. ↑ Yesiltepe, Metin; Cimen, Bariscan; Sara, Yildirim (15 September 2022). "Effects of chronic vagal nerve stimulation in the treatment of β-amyloid-induced neuropsychiatric symptoms". European Journal of Pharmacology 931: 175179. doi:10.1016/j.ejphar.2022.175179. PMID 35973478.

## Further reading

* "Report casts doubt on VNS approval. - Free Online Library". http://www.thefreelibrary.com/Report+casts+doubt+on+VNS+approval.-a0149222466.
* "Battle Lines in Treating Depression". The New York Times. September 10, 2006. https://www.nytimes.com/2006/09/10/business/yourmoney/10cyber.html.

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