Surgically implanted and non-invasive vagus nerve stimulation: A review of efficacy, safety and tolerability

European Journal of Neurology

Volumn 22, Issue 9, 2015, Pages 1260-1268

  Ben Menachem, E ^a   Revesz, D ^a   Simon, B J ^b   Silberstein, S ^c  

^a UNIVERSITY OF GOTHENBURG   (Sweden)

^b ElectroCore LLC   (United States)

^c THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Depression; Epilepsy; Headache; Implantable; Migraine; Safety; Transcutaneous; Vagus nerve stimulation

Indexed keywords

ALZHEIMER DISEASE; ANXIETY DISORDER; BRADYCARDIA; CLUSTER HEADACHE; COGNITIVE DEFECT; COMPLETE HEART BLOCK; COUGH HEADACHE; DEPRESSION; DEVICE SAFETY; DRUG RESISTANT EPILEPSY; DYSPNEA; ELECTRODE IMPLANTATION; EPILEPSY; FACIAL NERVE PARALYSIS; FATIGUE; GASTROINTESTINAL DISEASE; HEADACHE; HEART ARREST; HEART FAILURE; HUMAN; IMPLANTATION; IMPLANTED VAGUS NERVE STIMULATOR; MIGRAINE; NERVE FUNCTION; OBESITY; PARESTHESIA; PHARYNGITIS; POSTOPERATIVE COMPLICATION; POSTOPERATIVE INFECTION; POSTOPERATIVE PAIN; PRIORITY JOURNAL; PSYCHOMOTOR RETARDATION; REVIEW; SUICIDAL IDEATION; SURGICAL TECHNIQUE; TREATMENT RESISTANT DEPRESSION; VAGUS NERVE STIMULATION; VOCAL CORD PARALYSIS; VOICE CHANGE; ADVERSE EFFECTS; DEVICES; ELECTRODE IMPLANT; PROCEDURES; STANDARDS;

ELECTRODES, IMPLANTED; EQUIPMENT AND SUPPLIES; HUMANS; VAGUS NERVE STIMULATION;

EID: 84939469667     PISSN: 13515101     EISSN: 14681331     Source Type: Journal    
DOI: 10.1111/ene.12629     Document Type: Review

References (61)

1. Beekwilder JP, Beems T. Overview of the clinical applications of vagus nerve stimulation. J Clin Neurophysiol 2010; 27: 130-138.
2. Ben-Menachem E, Manon-Espaillat R, Ristanovic R, et al. Vagus nerve stimulation for treatment of partial seizures: 1. A controlled study of effect on seizures. First International Vagus Nerve Stimulation Study Group. Epilepsia 1994; 35: 616-626.
3. Ben-Menachem E. Vagus nerve stimulation, side effects, and long-term safety. J Clin Neurophysiol 2001; 18: 415-418.
4. Goadsby P, Lipton R, Cady R, Mauskop A, Grosberg B. Non-invasive vagus nerve stimulation (nVNS) for acute treatment of migraine: an open-label pilot study [abstract S40.004]. Presented at Annual Meeting of the American Academy of Neurology, 16-23 March 2013, San Diego, CA.
5. Jurgens TP, Leone M. Pearls and pitfalls: neurostimulation in headache. Cephalalgia 2013; 33: 512-525.
6. Hatton KW, McLarney JT, Pittman T, Fahy BG. Vagal nerve stimulation: overview and implications for anesthesiologists. Anesth Analg 2006; 103: 1241-1249.
7. Krahl SE. Vagus nerve stimulation for epilepsy: a review of the peripheral mechanisms. Surg Neurol Int 2012; 3: S47-S52.
8. Foley JO, Dubois F. Quantitative studies of the vagus nerve in the cat, I: The ratio of sensory and motor studies. J Comp Neurol 1937; 67: 49-67.
9. Massey BT. Physiology of oral cavity, pharynx and upper esophageal sphincter. GI Motility Online 2006. http://www.nature.com/gimo/contents/pt1/full/gimo2.html (accessed 09/26/2014).
10. Tewfik TL, Meyers AD. Vagus nerve anatomy. http://emedicine.medscape.com/article/1875813-overview (accessed 01/29/2014).
11. Ruffoli R, Giorgi FS, Pizzanelli C, Murri L, Paparelli A, Fornai F. The chemical neuroanatomy of vagus nerve stimulation. J Chem Neuroanat 2011; 42: 288-296.
12. Berthoud HR, Neuhuber WL. Functional and chemical anatomy of the afferent vagal system. Auton Neurosci 2000; 85: 1-17.
13. Lockard JS, Congdon WC, DuCharme LL. Feasibility and safety of vagal stimulation in monkey model. Epilepsia 1990; 31 (Suppl. 2): S20-S26.
14. Woodbury DM, Woodbury JW. Effects of vagal stimulation on experimentally induced seizures in rats. Epilepsia 1990; 31 (Suppl. 2): S7-S19.
15. Woodbury JW, Woodbury DM. Vagal stimulation reduces the severity of maximal electroshock seizures in intact rats: use of a cuff electrode for stimulating and recording. Pacing Clin Electrophysiol 1991; 14: 94-107.
16. Zabara J. Inhibition of experimental seizures in canines by repetitive vagal-stimulation. Epilepsia 1992; 33: 1005-1012.
17. Vagus Nerve Stimulation Study Group. A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. Neurology 1995; 45: 224-230.
18. Uthman BM, Wilder BJ, Penry JK, et al. Treatment of epilepsy by stimulation of the vagus nerve. Neurology 1993; 43: 1338-1345.
19. Cyberonics Inc. 2013 Annual Report. http://ir.cyberonics.com/annuals.cfm (accessed 03/05/2014).
20. Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res 2000; 42: 203-210.
21. Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A pilot study of mood in epilepsy patients treated with vagus nerve stimulation. Epilepsy Behav 2000; 1: 93-99.
22. Rush AJ, Marangell LB, Sackeim HA, et al. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry 2005; 58: 347-354.
23. Rush AJ, Sackeim HA, Marangell LB, et al. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study. Biol Psychiatry 2005; 58: 355-363.
24. VNS Therapy System Physician's Manual. Houston, TX: Cyberonics Inc., 2013. http://dynamic.cyberonics.com/manuals/ (accessed 01/05/2015).
25. Sadler RM, Purdy RA, Rahey S. Vagal nerve stimulation aborts migraine in patient with intractable epilepsy. Cephalalgia 2002; 22: 482-484.
26. Mauskop A. Vagus nerve stimulation relieves chronic refractory migraine and cluster headaches. Cephalalgia 2005; 25: 82-86.
27. Schwartz PJ, De Ferrari GM, Sanzo A, et al. Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail 2008; 10: 884-891.
28. Merrill CA, Jonsson MA, Minthon L, et al. Vagus nerve stimulation in patients with Alzheimer's disease: additional follow-up results of a pilot study through 1 year. J Clin Psychiatry 2006; 67: 1171-1178.
29. Sjogren MJ, Hellstrom PT, Jonsson MA, Runnerstam M, Silander HC, Ben-Menachem E. Cognition-enhancing effect of vagus nerve stimulation in patients with Alzheimer's disease: a pilot study. J Clin Psychiatry 2002; 63: 972-980.
30. George MS, Ward HE Jr, Ninan PT, et al. A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders. Brain Stimul 2008; 1: 112-121.
31. Roslin M, Kurian M. VNS in the treatment of morbid obesity. In: Schacter SC, Schmidt D, eds. VNS. Martin-Dunitz: London, 2012: 113-121.
32. Ben-Menachem E. Vagus-nerve stimulation for the treatment of epilepsy. Lancet Neurol 2002; 1: 477-482.
33. Handforth A, DeGiorgio CM, Schachter SC, et al. Vagus nerve stimulation therapy for partial-onset seizures: a randomized active-control trial. Neurology 1998; 51: 48-55.
34. Morris GL III, Mueller WM, the Vagus Nerve Stimulation Study Group E01-E05. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. Neurology 1999; 53: 1731-1735.
35. Tatum WO, Moore DB, Stecker MM, et al. Ventricular asystole during vagus nerve stimulation for epilepsy in humans. Neurology 1999; 52: 1267-1269.
36. Ali II, Pirzada NA, Kanjwal Y, et al. Complete heart block with ventricular asystole during left vagus nerve stimulation for epilepsy. Epilepsy Behav 2004; 5: 768-771.
37. Ardesch JJ, Buschman HP, van der Burgh PH, Wagener-Schimmel LJ, van der Aa HE, Hageman G. Cardiac responses of vagus nerve stimulation: intraoperative bradycardia and subsequent chronic stimulation. Clin Neurol Neurosurg 2007; 109: 849-852.
38. Schuurman PR, Beukers RJ. Ventricular asystole during vagal nerve stimulation. Epilepsia 2009; 50: 967-968.
39. Amark P, Stodberg T, Wallstedt L. Late onset bradyarrhythmia during vagus nerve stimulation. Epilepsia 2007; 48: 1023-1024.
40. Borusiak P, Zilbauer M, Cagnoli S, Heldmann M, Jenke A. Late-onset cardiac arrhythmia associated with vagus nerve stimulation. J Neurol 2009; 256: 1578-1580.
41. Iriarte J, Urrestarazu E, Alegre M, et al. Late-onset periodic asystolia during vagus nerve stimulation. Epilepsia 2009; 50: 928-932.
42. Ben-Menachem E, Hellstrom K, Waldton C, Augustinsson LE. Evaluation of refractory epilepsy treated with vagus nerve stimulation for up to 5 years. Neurology 1999; 52: 1265-1267.
43. Husain MM, Stegman D, Trevino K. Pregnancy and delivery while receiving vagus nerve stimulation for the treatment of major depression: a case report. Ann Gen Psychiatry 2005; 4: 16.
44. CardioFit Pilot Study. Promising results from the CardioFit pilot study. http://www.biocontrol-medical.com/health_pros.php?ID=23 (accessed 02/10/2014).
45. Sabbah HN. Electrical vagus nerve stimulation for the treatment of chronic heart failure. Clevel Clin J Med 2011; 78 (Suppl. 1): S24-S29.
46. Abraham WT, De Ferrari GM. Novel non-pharmacological approaches to heart failure. J Cardiovasc Transl Res 2014; 7: 263-265.
47. De Ferrari GM, Crijns HJ, Borggrefe M, et al. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J 2011; 32: 847-855.
48. ® t-VNS for treatment of drug-resistant epilepsy. http://cerbomed.com/upload/Brochure_Epilepsy_Patients_EN.pdf (accessed 01/29/2014).
49. Stefan H, Kreiselmeyer G, Kerling F, et al. Transcutaneous vagus nerve stimulation (t-VNS) in pharmacoresistant epilepsies: a proof of concept trial. Epilepsia 2012; 53: e115-e118.
50. Busch V, Zeman F, Heckel A, Menne F, Ellrich J, Eichhammer P. The effect of transcutaneous vagus nerve stimulation on pain perception - an experimental study. Brain Stimul 2013; 6: 202-209.
51. Napadow V, Edwards RR, Cahalan CM, et al. Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med 2012; 13: 777-789.
52. Nesbitt AD, Marin JCA, Tomkins E, Ruttledge MH, Goadsby PJ. Non-invasive vagus nerve stimulation for the treatment of cluster headache: a cohort series with extended follow-up [abstract; oral presentation]. Presented at Biennial World Congress of the International Neuromodulation Society, 8-13 June 2013, Berlin, Germany.
53. Nesbitt AD, Marin JCA, Tomkins E, Ruttledge MH, Goadsby PJ. Non-invasive vagus nerve stimulation for the treatment of cluster headache: a cohort study [abstract P141]. Cephalalgia 2013; 33: 107.
54. Goadsby P, Grosberg B, Mauskop A, Cady R, Simmons K. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia 2014; 34: 986-993.
55. Moscato D, Moscato FR. Treatment of chronic migraine by means of vagal stimulator [abstract]. J Headache Pain 2013; 14 (Suppl): 56-57.
56. El Tahry R, Raedt R, Mollet L, et al. A novel implantable vagus nerve stimulation system (ADNS-300) for combined stimulation and recording of the vagus nerve: pilot trial at Ghent University Hospital. Epilepsy Res 2010; 92: 231-239.
57. Ben-Menachem E, Rydenhag B, Silander H. Preliminary experience with a new system for vagus nerve stimulation for the treatment of refractory focal onset seizures. Epilepsy Behav 2013; 29: 416-419.
58. Hein E, Nowak M, Kiess O, et al. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm 2013; 120: 821-827.
59. Nahas Z, Marangell LB, Husain MM, et al. Two-year outcome of vagus nerve stimulation (VNS) for treatment of major depressive episodes. J Clin Psychiatry 2005; 66: 1097-1104.
60. Siddiqui F, Herial NA, Ali II. Cumulative effect of vagus nerve stimulators on intractable seizures observed over a period of 3 years. Epilepsy Behav 2010; 18: 299-302.
61. Ryzi M, Brazdil M, Novak Z, et al. Long-term vagus nerve stimulation in children with focal epilepsy. Acta Neurol Scand 2013; 127: 316-322.