“Vagus nerve stimulation”的意思、由来-开放百科全书

VNS devices are used to treat drug-resistant epilepsy and treatment-resistant major depressive disorder (TR-MDD).^[2]^[3]^[5] Specifically it is used for treatment-resistant focal epilepsy.^[3] As of 2017 the efficacy of VNS for TR-MDD was unclear.^[2]^[4]

Adverse events

For the treatment of epilepsy generally the left vagus nerve is stimulated at mid-cervical region. The adverse effects of this stimulation include cardiac arrest,^[5] bradycardia,^[6] voice alteration and hoarseness, cough, shortness of breath, pain, a tingling sensation, nausea, and headache;^[3] difficulty swallowing has also been reported as common,^[7] as well as sleepiness.

In randomized controlled trials for epilepsy conducted in the United States, one-third of the subjects had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase, some had 100 percent increase or more.^[8]

Mechanism of action

As of 2017 little was understood about exactly how vagal nerve stimulation modulates mood and seizure control.^[2]

The vagus is the tenth cranial nerve and arises from the medulla; it carries both afferent and efferent fibers. The afferent vagal fibers connect to the nucleus of the solitary tract which in turn projects connections to other locations in the central nervous system.^[3] Proposed mechanisms include an anti-inflammatory effect,^[3] as well as changes in monoamines.

Devices and procedures

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.^[2]

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.^[4]^[9] 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.^[4]

"Wearable" devices are being tested and developed that involve transcutaneous stimulation and do not require surgery. Electrical impulses are targeted at the aurical (ear), at points where branches of the vagus nerve have cutaneous representation; such devices had been tested in clinical trials for treatment resistant major depressive disorder as of 2017.^[4]^[10]

History

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 renamed to LivaNova).^[2]

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.^[11]^[12] In January 2018, the FDA cleared a new user for that device for the treatment of migraine pain in adults under a 510(k) based on the de novo clearance.^[13]^[14]

Society and culture

Although the use of VNS for TRD has been endorsed by the American Psychiatric Association, the FDA's approval of VNS for TRD remains controversial. According to Dr. A. John Rush, vice chairman for research in the Department of Psychiatry at the University of Texas Southwestern Medical Center at Dallas, results of the VNS pilot study showed that 40 percent of the treated patients displayed at least a 50 percent or greater improvement in their condition, according to the Hamilton Depression Rating Scale.^[15]^[16] Many other studies concur that VNS is indeed efficacious in treating depression. However, these findings do not take into account improvements over time in patients without the device. In the only randomized controlled trial VNS failed to perform any better when turned on than in otherwise similar implanted patients whose device was not turned on.^[17]

Research

Because the vagus nerve is associated with many different functions and brain regions, clinical research has been done to determine its usefulness in treating other illnesses, including various anxiety disorders,^[18] obesity,^[19]^[20] alcohol addiction,^[21] chronic heart failure,^[22] prevention of arrhythmias that can cause sudden cardiac death,^[23] autoimmune disorders,^[24]^[25] and several chronic pain conditions.^[26]

VNS has also been studied in small trials of people with neurodevelopmental disorders, generally who also have had epilepsy, including Landau-Kleffner syndrome, Rett syndrome, and autism spectrum disorders.^[27]

As of 2015 VNS devices were being developed that were not implanted, but rather transmitted signals through the skin. Electrical impulses are targeted at the aurical (ear), at points where branches of the vagus nerve are close to the surface.^[4]^[10]

VNS is being studied as of 2018 as a treatment for migraines and fibromyalgia.^[28]^[29]

See also

References

1. ^¹{{cite web |title=Vagus Nerve Stimulation |url=https://my.clevelandclinic.org/health/treatments/17598-vagus-nerve-stimulation |website=Cleveland Clinic |accessdate=19 October 2018 |language=en}}
2. ^¹²³⁴{{cite journal|last1=Edwards|first1=CA|last2=Kouzani|first2=A|last3=Lee|first3=KH|last4=Ross|first4=EK|title=Neurostimulation Devices for the Treatment of Neurologic Disorders|journal=Mayo Clinic Proceedings|date=September 2017|volume=92|issue=9|pages=1427–1444|doi=10.1016/j.mayocp.2017.05.005|pmid=28870357}} {{open access}}
3. ^¹²³⁴{{cite journal |last1=Panebianco |first1=M|last2=Rigby |first2=A|last3=Weston |first3=J|last4=Marson |first4=AG |title=Vagus nerve stimulation for partial seizures|journal=The Cochrane Database of Systematic Reviews|date=3 April 2015 |issue=4 |pages=CD002896 |doi=10.1002/14651858.CD002896.pub2 |pmid=25835947}} {{open access}}
4. ^¹²³⁴⁵⁶{{cite journal|last1=Carreno|first1=FR|last2=Frazer|first2=A|title=Vagal Nerve Stimulation for Treatment-Resistant Depression|journal=Neurotherapeutics|date=July 2017|volume=14|issue=3|pages=716–727|doi=10.1007/s13311-017-0537-8|pmid=28585221|pmc=5509631}}
5. ^Lenzer, Jeanne (2017) The Danger Within Us pg.109 {{ISBN|9780316343763}}
6. ^Han p, frei mg, osorio i. Probable mechanisms of action of vagus nerve stimulation in humans with epilepsy: is a window into the brain [abstract]? epilepsia 1996;37 (5suppl):83s.
7. ^{{cite journal |last1=Howland |first1=RH |title=Vagus Nerve Stimulation |journal=Current Behavioral Neuroscience Reports |date=June 2014 |volume=1 |issue=2 |pages=64–73 |doi=10.1007/s40473-014-0010-5 |pmid=24834378 |pmc=4017164}}
8. ^{{cite web |title=Neurological Devices Panel: Tenth Meeting transcript |url=http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf |publisher=FDA |archiveurl=https://web.archive.org/web/20000819110902/http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf|archivedate=August 19, 2000 |date=June 27, 1997|page=125}}
9. ^{{cite journal|last1=Giordano|first1=F|last2=Zicca|first2=A|last3=Barba|first3=C|last4=Guerrini|first4=R|last5=Genitori|first5=L|title=Vagus nerve stimulation: Surgical technique of implantation and revision and related morbidity|journal=Epilepsia|date=April 2017|volume=58 Suppl 1|pages=85–90|doi=10.1111/epi.13678|pmid=28386925}}
10. ^¹{{cite journal |pages=287–95 |doi=10.3389/fpsyg.2015.00102 |title=Transcutaneous Vagal Nerve Stimulation (tVNS): a new neuromodulation tool in healthy humans? |year=2015 |last1=Leusden |first1=J |journal=Frontiers in Psychology |volume=6 |issue=102 |pmc=4322601 |last2=Sellare |first2=R |last3=Colzato |first3=L |display-authors=2 |pmid=25713547}}
11. ^{{cite news |last1=Brauser |first1=Deborah |title=FDA Approves Vagus Nerve Stimulation Device for Cluster Headache |url=https://www.medscape.com/viewarticle/878763 |work=Medscape |date=April 18, 2017}}
12. ^{{cite news |title=GammaCore Device Classification under Section 513(f)(2)(de novo) |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN150048 |accessdate=6 June 2018 |work=FDA}}
13. ^{{cite news |last1=Brauser |first1=Deborah |title=FDA Clears Vagus Nerve Stimulator for Migraine Pain |url=https://www.medscape.com/viewarticle/891930 |work=Medscape |date=January 29, 2018}}
14. ^{{cite web |title=GammaCore 510(k) Premarket Notification |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173442 |publisher=FDA |accessdate=6 June 2018}}
15. ^Doctor's Guide: Vagus Nerve Stimulation Successful For Depression
16. ^Neurology Channel: Vagus Nerve Stimulation {{webarchive |url=https://web.archive.org/web/20051027154834/http://www.neurologychannel.com/vagus/ |date=October 27, 2005 }}
17. ^FDA Summary of VNS Data
18. ^{{cite journal |doi=10.1016/j.neubiorev.2005.01.004 |pmid=15820552 |title=Vagal nerve stimulation: A review of its applications and potential mechanisms that mediate its clinical effects |year=2005 |last1=Groves |first1=Duncan A. |last2=Brown |first2=Verity J. |journal=Neuroscience & Biobehavioral Reviews |volume=29 |issue=3 |pages=493–500}}
19. ^{{cite journal |last1=de Lartigue |first1=G |title=Role of the vagus nerve in the development and treatment of diet-induced obesity |journal=The Journal of Physiology |date=15 October 2016 |volume=594 |issue=20 |pages=5791–5815 |doi=10.1113/JP271538 |pmid=26959077 |pmc=5063945}}
20. ^{{cite journal|last1=Göbel|first1=CH|last2=Tronnier|first2=VM|last3=Münte|first3=TF|title=Brain stimulation in obesity|journal=International Journal of Obesity|volume=41|issue=12|pages=1721–1727|date=30 June 2017|doi=10.1038/ijo.2017.150|pmid=28663570}}
21. ^{{cite journal |vauthors=Herremans SC, Baeken C |title=The current perspective of neuromodulation techniques in the treatment of alcohol addiction: a systematic review |journal=Psychiatria Danubina |volume=24 |issue=Suppl 1 |pages=S14–20 |date=September 2012 |pmid=22945180 |url=http://www.hdbp.org/psychiatria_danubina/pdf/dnb_vol24%20Suppl%201_no/dnb_vol24%20Suppl%201_no_S14.pdf}}
22. ^{{cite journal |vauthors=Abraham WT, Smith SA |title=Devices in the management of advanced, chronic heart failure |journal=Nature Reviews. Cardiology |volume=10 |issue=2 |pages=98–110 |date=February 2013 |pmid=23229137 |pmc=3753073 |doi=10.1038/nrcardio.2012.178}}
23. ^{{cite journal |last1=Sabbah |first1=HN |title=Electrical vagus nerve stimulation for the treatment of chronic heart failure |journal=Cleveland Clinic Journal of Medicine |date=August 2011 |volume=78 Suppl 1 |pages=S24–9 |doi=10.3949/ccjm.78.s1.04 |pmid=21972326 |pmc=3817894}}
24. ^{{Citation | last = Fox | first = Douglas | title = Can Zapping the Vagus Nerve Jump-Start Immunity? : An experimental procedure is exposing links between nervous and immune systems | url = https://www.scientificamerican.com/article/can-zapping-the-vagus-nerve-jump-start-immunity/ | publisher = Scientific American | date = 4 May 2017 }}
25. ^{{cite journal |last1=Koopman |first1=FA |last2=van Maanen |first2=MA |last3=Vervoordeldonk |first3=MJ |last4=Tak |first4=PP |title=Balancing the autonomic nervous system to reduce inflammation in rheumatoid arthritis |journal=J. Intern. Med. |date=2017 |volume=282(1) |pages=64–75 }}
26. ^{{cite journal |last1=Chakravarthy |first1=K |last2=Chaudhry |first2=H |last3=Williams |first3=K |last4=Christo |first4=PJ |title=Review of the Uses of Vagal Nerve Stimulation in Chronic Pain Management |journal=Current Pain and Headache Reports |date=December 2015 |volume=19 |issue=12 |pages=54 |doi=10.1007/s11916-015-0528-6 |pmid=26493698}}
27. ^{{cite journal|last1=Engineer|first1=CT|last2=Hays|first2=SA|last3=Kilgard|first3=MP|title=Vagus nerve stimulation as a potential adjuvant to behavioral therapy for autism and other neurodevelopmental disorders|journal=Journal of Neurodevelopmental Disorders|date=2017|volume=9|pages=20|doi=10.1186/s11689-017-9203-z|pmid=28690686|pmc=5496407}}
28. ^{{cite journal |last1=Johnson |first1=RL |last2=Wilson |first2=CG |title=A review of vagus nerve stimulation as a therapeutic intervention |journal=Journal of Inflammation Research |date=2018 |volume=11 |pages=203–213 |doi=10.2147/JIR.S163248 |pmid=29844694 |pmc=5961632}}
29. ^{{cite journal|last1=Puledda|first1=F|last2=Goadsby|first2=PJ|title=An Update on Non-Pharmacological Neuromodulation for the Acute and Preventive Treatment of Migraine|journal=Headache|date=April 2017|volume=57|issue=4|pages=685–691|doi=10.1111/head.13069|pmid=28295242}}

Medical use