Vagus nerve stimulator

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The vagus nerve stimulation (VNS) is approved in Europe for the treatment of drug-resistant epilepsy (MRE) and the refractory depression. Treatment is done by stimulating the vagus nerve. The vagus nerve is the tenth of a total of twelve cranial nerves and innervates several organs such as B. Heart, lungs, and gastrointestinal tract. VNS was first approved in the European Union in 1994 and three years later in the United States. A system for transcutaneous vagus nerve stimulation (t-VNS) was approved in Europe in 2010 .

VNS

In the VNS, a stimulation device similar to a pacemaker is implanted in the chest area under the skin during a minimally invasive procedure, which is usually connected to the left vagus nerve via an electrode . The generator sends regular electrical impulses (usually every 5 minutes for 30 seconds) via the vagus nerve to the brain and thus unfolds its anticonvulsant and antidepressant effects. The effectiveness and safety of the VNS in MDROs has been confirmed in hundreds of studies over 20 years. In 13 class III studies it was shown that VNS achieved a seizure reduction of 50% or more in 55% of patients with drug-resistant epilepsy. Long-term studies have shown that patients who have been treated with VNS for more than 2 years can expect higher seizure reductions of up to 76%. In addition to reducing seizure frequency, VNS can significantly reduce seizure duration, seizure severity, duration of the postictal phase, and frequency of status epilepticus. A Cochrane review of 4 randomized, double-blind studies of VNS found that high-dose VNS caused greater seizure reduction than low-dose VNS. The most common side effects of VNS are cough, hoarseness, and dysphonia, but these side effects usually only occur when the device is stimulating and decrease over time. In refractory depression, the long-term MADRS responder rate is around 50% and around 20% of patients achieve permanent remission after 2 years. The German Society for Epileptology recommends VNS for difficult-to-treat epilepsies, if 2 anti-epileptic drugs (or combinations of anti-epileptic drugs) have not achieved freedom from seizures and the patient is not a candidate for epilepsy surgery or rejects it.

Mechanism of action

Numerous human and animal studies describe different aspects of the VNS mechanisms. The nucleus tractus solitarii is the main recipient of vagal afferents and is functionally and stimulation-dependently modulated by VNS in animal models. The nucleus tractus solitarii projects directly to the raphe nuclei in the brain stem, the main source of serotonin in the brain, and to the locus caeruleus , the main source of norepinephrine in the brain. This may explain changes in neurotransmitter levels in the CSF of patients after VNS, which could result in an anticonvulsant effect. A significant increase in bilateral thalamic blood flow is observed in patients with refractory epilepsy, which could explain the known increase in vigilance in VNS patients, as well as an improvement in the interictal EEG (fewer spikes and larger spike-free periods) due to VNS.

Transcutaneous VNS (t-VNS)

Transcutaneous vagus nerve stimulation (t-VNS) is based on the fact that a branch of the vagus nerve, the so-called Ramus auricularis nervi vagi (RANV), sensitively supplies the skin of the auricle in the area of the concha. This branch can be stimulated transcutaneously, i.e. through the skin, with electrical impulses. A surgical intervention is not necessary here. In the first randomized, double-blind study with tVNS, neither a dose-response relationship nor a difference in the responder rates between the active and control group could be shown. The seizure reduction with tVNS in this study in the active group was 23.4%. It is assumed that the stimulation of the ramus auricularis nervi vagi causes an excitation of the vagus nerve, which, as with conventional VNS, reaches higher centers of the brain via the brain stem and that an anticonvulsant effect is achieved in this way. However, this must first be confirmed in studies. The therapy takes place with a device that generates electrical impulses and is about the size of a conventional smartphone. A special ear electrode, which is worn like headphones, sends the impulses through the skin to the branch of the vagus nerve.

Other areas of application

The effectiveness of the vagus nerve stimulator in the treatment of other psychiatric conditions such as e.g. B. Anxiety disorders , Alzheimer's disease , migraines and cluster headache studied. A pilot study on VNS in Crohn's disease showed effectiveness in a small group of patients, but this has to be confirmed in larger studies.

A randomized clinical study from 2014 confirmed that t-VNS is an effective form of therapy for the prophylaxis of migraines. The study was carried out with the approximately smartphone-sized VITOS therapy device from cerbotec GmbH. With this device, the patient can carry out the therapy independently from home. The procedure is mainly used in patients with severe or chronic migraines.

Another method of non-invasive transcutaneous vagus nerve stimulation is the generation of an electric field above the vagus nerve at the level of the carotid artery. The vagus nerve is stimulated for about 2 minutes by applying a hand-sized device to the neck. This method is approved in the European Union for the treatment of primary headache, depression, anxiety disorder and epilepsy. Studies on the therapy of migraines and cluster headaches have already been published.

Research is also looking at vagus nerve stimulation for detecting a minimal state of consciousness.

Web links

Vagus Nerve Stimulator , Freiburg University Hospital, Epileptology Section

Individual evidence

↑ Summary of Safety and Effectiveness Data. FDA.GOV, accessed September 27, 2016 .
↑ Morris et al .: Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy: report of the Guideline Development Subcommittee of the American Academy of Neurology . Ed .: Neurology. 2013, doi : 10.1212 / WNL.0b013e3182a393d1 .
↑ Elliott et al .: Efficacy of vagus nerve stimulation over time: review of 65 consecutive patients with treatment-resistant epilepsy treated with VNS> 10 years . Ed .: Epilepsy Behavior. 2011, doi : 10.1016 / j.yebeh.2010.12.042 .
↑ Orosz et al .: Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children . 2014, doi : 10.1111 / epi.12762 .
↑ Helmers: Clinical and economic impact of vagus nerve stimulation therapy in patients with drug-resistant epilepsy . Ed .: Epilepsy Behav. 2011, doi : 10.1016 / j.yebeh.2011.07.020 .
↑ Panebianco et al .: Vagus nerve stimulation for partial seizures . Ed .: Cochrane Database Syst Rev. 2015, doi : 10.1002 / 14651858 .
↑ Morris et al .: Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. In: Neurology (Ed.): Nov 10; 53 (8): 1731-1735 . 1999.
↑ Berry et al .: A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression . Ed .: Med Devices. Auckland 2013, doi : 10.2147 / MDER.S41017 .
^ Walter Fröscher, Theodor W May: Difficult to treat epilepsy 079 . Ed .: German Society for Epileptology. June 2016 (izepilepsie.de).
↑ Furmaga: Comparison of ΔFosB immunoreactivity induced by vagal nerve stimulation with did Caused by pharmacologically various antidepressants . Ed .: J Pharmacol Exp Ther. 2012, doi : 10.1124 / jpet.111.188953 .
↑ Ben-Menachem et al .: Effects of vagus nerve stimulation on amino acids and other metabolites in the CSF of patients with partial seizures . Ed .: Epilepsy Research. 1995.
^ Henry et al .: Significant bilateral changes in blood flow have been observed during VNS Therapy . Ed .: Epilepsia. 1998.
↑ Koo et al: VNS Therapy induces progressive EEG changes . Ed .: J Clin Neurophysiol. 2001.
^ Peuker ET, Filler TJ: The nerve supply of the human auricle . Clin Anat 2002; 15: 35-37.
↑ Bauer et al .: Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02). Ed .: Braim Stmul. 2016, doi : 10.1016 / j.brs.2015.11.0 .
^ Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care. Retrieved September 27, 2016 .
↑ Bonaz et al .: Chronic vagus nerve stimulation in Crohn's disease: a 6-month follow-up pilot study. Ed .: Neurogastroenterolog Motil. 2016, doi : 10.1111 / nmo.12792 .
↑ Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. Retrieved September 27, 2016 .
↑ Nesbitt et al .: Non-invasive vagus nerve stimulation for the treatment of cluster headache: a case series. The Journal of Headache and Pain 2013 1 (Suppl 1): P231.
↑ S40 Headache: Clinical Non-Invasive Vagus Nerve Stimulation (nVNS) for Acute Treatment of Migraine: An Open-Label Pilot Study (S40.004)
↑ Daniela Zeibig: Nerve stimulation brings back consciousness. In: Spektrum.de. September 25, 2017. Retrieved December 7, 2019 .
↑ P. Bourdillon, B. Hermann, JD Sitt, L. Naccache: Electromagnetic Brain Stimulation in Patients With Disorders of Consciousness . In: Frontiers in Neuroscience . tape 13 , 2019, pp. 223 , doi : 10.3389 / fnins.2019.00223 , PMID 30936822 , PMC 6432925 (free full text).

[1] Summary of Safety and Effectiveness Data. FDA.GOV, accessed September 27, 2016 .

[2] Morris et al .: Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy: report of the Guideline Development Subcommittee of the American Academy of Neurology . Ed .: Neurology. 2013, doi : 10.1212 / WNL.0b013e3182a393d1 .

[3] Elliott et al .: Efficacy of vagus nerve stimulation over time: review of 65 consecutive patients with treatment-resistant epilepsy treated with VNS> 10 years . Ed .: Epilepsy Behavior. 2011, doi : 10.1016 / j.yebeh.2010.12.042 .

[4] Orosz et al .: Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children . 2014, doi : 10.1111 / epi.12762 .

[5] Helmers: Clinical and economic impact of vagus nerve stimulation therapy in patients with drug-resistant epilepsy . Ed .: Epilepsy Behav. 2011, doi : 10.1016 / j.yebeh.2011.07.020 .

[6] Panebianco et al .: Vagus nerve stimulation for partial seizures . Ed .: Cochrane Database Syst Rev. 2015, doi : 10.1002 / 14651858 .

[7] Morris et al .: Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. In: Neurology (Ed.): Nov 10; 53 (8): 1731-1735 . 1999.

[8] Berry et al .: A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression . Ed .: Med Devices. Auckland 2013, doi : 10.2147 / MDER.S41017 .

[9] Walter Fröscher, Theodor W May: Difficult to treat epilepsy 079 . Ed .: German Society for Epileptology. June 2016 (izepilepsie.de).

[10] Furmaga: Comparison of ΔFosB immunoreactivity induced by vagal nerve stimulation with did Caused by pharmacologically various antidepressants . Ed .: J Pharmacol Exp Ther. 2012, doi : 10.1124 / jpet.111.188953 .

[11] Ben-Menachem et al .: Effects of vagus nerve stimulation on amino acids and other metabolites in the CSF of patients with partial seizures . Ed .: Epilepsy Research. 1995.

[12] Henry et al .: Significant bilateral changes in blood flow have been observed during VNS Therapy . Ed .: Epilepsia. 1998.

[13] Koo et al: VNS Therapy induces progressive EEG changes . Ed .: J Clin Neurophysiol. 2001.

[14] Peuker ET, Filler TJ: The nerve supply of the human auricle . Clin Anat 2002; 15: 35-37.

[15] Bauer et al .: Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02). Ed .: Braim Stmul. 2016, doi : 10.1016 / j.brs.2015.11.0 .

[16] Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care. Retrieved September 27, 2016 .

[17] Bonaz et al .: Chronic vagus nerve stimulation in Crohn's disease: a 6-month follow-up pilot study. Ed .: Neurogastroenterolog Motil. 2016, doi : 10.1111 / nmo.12792 .

[18] Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. Retrieved September 27, 2016 .

[19] Nesbitt et al .: Non-invasive vagus nerve stimulation for the treatment of cluster headache: a case series. The Journal of Headache and Pain 2013 1 (Suppl 1): P231.

[20] S40 Headache: Clinical Non-Invasive Vagus Nerve Stimulation (nVNS) for Acute Treatment of Migraine: An Open-Label Pilot Study (S40.004)

[21] Daniela Zeibig: Nerve stimulation brings back consciousness. In: Spektrum.de. September 25, 2017. Retrieved December 7, 2019 .

[22] P. Bourdillon, B. Hermann, JD Sitt, L. Naccache: Electromagnetic Brain Stimulation in Patients With Disorders of Consciousness . In: Frontiers in Neuroscience . tape 13 , 2019, pp. 223 , doi : 10.3389 / fnins.2019.00223 , PMID 30936822 , PMC 6432925 (free full text).