The Parasym tVNS Device, Scientific Publications

The Parasym tVNS (Transcutaneous Vagus Nerve Stimulation) device, uses the methodology of noninvasive stimulation of the vagus nerve, which has been assessed in many scientific publications. The Parasym tVNS device, as well as other tVNS devices have been assessed for their safety and efficacy in a number of therapeutic applications. References of these studies are below. 

 

[1] Terry R. Vagus nerve stimulation: a proven therapy for treatment of epilepsy strives to improve efficacy and expand applications. In: Conf Proc . Annu Int Conf IEEE Eng Med Biol Soc IEEE Eng Med Biol Soc Annu Conf, 2009; 2009. p. 4631e4. https://doi.org/10.1109/IEMBS.2009.5332676.

 

[2] Andersson U, Tracey KJ. A new approach to rheumatoid arthritis: treating inflammation with computerized nerve stimulation. Cerebrum 2012;2012:3.

 

[3] Zhang Y, Popovi c ZB, Bibevski S, Fakhry I, Sica DA, Van Wagoner DR, et al.Chronic vagus nerve stimulation improves autonomic control and attenuates systemic inflammation and heart failure progression in a canine high-rate pacing model. Circ Heart Fail 2009;2:692e9. https://doi.org/10.1161/CIRCHEARTFAILURE.109.873968.

                    

[4]  Giordano F, Zicca A, Barba C, Guerrini R, Genitori L. Vagus nerve stimulation:surgical technique of implantation and revision and related morbidity. Epilepsia 2017. https://doi.org/10.1111/epi.13678.

                        

[5]  Yuan H, Silberstein SD. Vagus nerve and vagus nerve stimulation, a comprehensive review: part II. Headache 2016. https://doi.org/10.1111/head.12650.

 

[6]  Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ 2016;352. https://doi.org/10.1136/bmj.i157.

    

[7]  Loke YK, Price D, Herxheimer A. Systematic reviews of adverse effects: framework for a structured approach. BMC Med Res Meth 2007;7. https://doi.org/10.1186/1471-2288-7-32.

 

 

[8]  Tan J-Y, Molassiotis A, Wang T, Suen LKP. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med 2014. https://doi.org/10.1155/2014/506758.

                        

[9]  Laud PJ. Equal-tailed confidence intervals for comparison of rates. Pharmaceut Stat 2017;16:334e48. https://doi.org/10.1002/pst.1813.

 

[10]  Aihua L, Lu S, Liping L, Xiuru W, Hua L, Yuping W. A controlled trial of transcutaneous vagus nerve stimulation for the treatment of pharmacoresistant epilepsy. Epilepsy Behav 2014;39:105e10. https://doi.org/10.1016/ j.yebeh.2014.08.005.

                        

[11]  Altavilla R, Paolucci M, Altamura C, Vernieri F. P038. Effects of non-invasive vagus nerve stimulation on cerebral vasomotor reactivity in patients with chronic migraine during intercritical phase: a pilot study. J Headache Pain 2015;16:A62. https://doi.org/10.1186/1129-2377-16-S1-A62.

 

[12]  Assenza G, Campana C, Colicchio G, Tombini M, Assenza F, Di Pino G, et al. Transcutaneous and invasive vagal nerve stimulations engage the same neural pathways: in-vivo human evidence. Brain Stimul 2017;10:853e4. https:// doi.org/10.1016/j.brs.2017.03.005.

 

 

[13]  Badran BW, Glusman CE, Badran AW, Austelle C, DeVries WH, Borckardt JJ, George MS. Development, safety and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS); a novel form of noninvasive vagus nerve stimulation. Neuropsychopharmacology 2015;40(Suppl:S518e9).

 

 

[14]  Barbanti P, Grazzi L, Egeo G, Padovan AM, Liebler E, Bussone G. Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study. J Headache Pain 2015;16:61. https://doi.org/ 10.1186/s10194-015-0542-4.

 

                        

[15]  Bauer S, Baier H, Baumgartner C, Bohlmann K, Fauser S, Graf W, et al. Transcutaneous vagus nerve stimulation (tVNS) for treatment of drug- resistant epilepsy: a randomized, double-blind clinical trial (cMPsE02). Brain Stimul 2016:1e8. https://doi.org/10.1016/j.brs.2015.11.003.

 

[16]  Burger AM, Verkuil B, Van Diest I, Van der Does W, Thayer JF, Brosschot JF. The effects of transcutaneous vagus nerve stimulation on conditioned fear extinction in humans. Neurobiol Learn Mem 2016;132:49e56. https://doi.org/ 10.1016/j.nlm.2016.05.007.

 

 

[17]  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;6:202e9. https://doi.org/10.1016/j.brs.2012.04.006.

 

 

[18]  Capone F, Assenza G, Di Pino G, Musumeci G, Ranieri F, Florio L, et al. The effect of transcutaneous vagus nerve stimulation on cortical excitability. J Neural Transm 2014;122:679e85. https://doi.org/10.1007/s00702-014- 1299-7.                                                     

[19]  Cha WW, Song K, Lee HY. Persistent geotropic direction-changing positional nystagmus treated with transcutaneous vagus nerve stimulation. Brain Stimul 2016;9:469e70. https://doi.org/10.1016/j.brs.2016.03.011.

                        

[20]  Davies, B. and Chatterton K. Non-invasive vagus nerve stimulation for hemicrania continua: a case series of 3 patients. Cephalalgia, n.d., p. 93.

 

 

[21]  Dietrich S, Smith J, Scherzinger C, Hofmann-Preiß K, Freitag T, Eisenkolb A, et al. A novel transcutaneous vagus nerve stimulation leads to brainstem and cerebral activations measured by functional MRI. Biomed Tech 2008;53: 104e11. https://doi.org/10.1515/BMT.2008.022.

 

                        

[22]  Finetti C. No Title. Transcutaneous vagus nerve stimulation a child with dravet syndrome a case report 2015;28(2):161e164.

 

                        

[23]  Gaul C, Diener H-C, Silver N, Magis D, Reuter U, Andersson A, et al. Non- invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): a randomised controlled study. Cephalalgia 2015. https://doi.org/10.1177/0333102415607070.

 

[24]  Goadsby PJ, Grosberg BM, Mauskop A, Cady R, Simmons KA. Effect of non invasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia 2014;34:986e93. https://doi.org/10.1177/0333102414524494.

       

[25]  Grazzi L, Usai S, Bussone G. Gammacore device for treatment of migraine attack: preliminary report. Neurology 2014;82(10 Supp). I9-2.

 

[26]  Grazzi L, Egeo G, Calhoun AH, McClure CK, Liebler E, Barbanti P. Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/ menstrually related migraine: an open-label study. J Headache Pain 2016;17: 91. https://doi.org/10.1186/s10194-016-0684-z.

 

[27]  Grazzi L, Egeo G, Liebler E, Barbanti P. NON-INVASIVE vagus nerve stimulation (nvns) for the acute treatment of migraine without aura in adolescents: PRELIMINARY clinical experience. Cephalalgia 2016;36:104.

 

                        

[28]  Hasan A, Wolff-Menzler C, Pfeiffer S, Falkai P, Weidinger E, Jobst A, et al. Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study. Eur Arch Psychiatry Clin Neurosci 2015. https://doi.org/10.1007/s00406-015-0618-9.

                                            

[29] He W, Jing X, Wang X, Rong P, Li L, Shi H, et al. Transcutaneous auricular vagus nerve stimulation as a complementary therapy for pediatric epilepsy: a pilot trial. Epilepsy Behav 2013;28:343e6. https://doi.org/10.1016/ j.yebeh.2013.02.001.

                    

[30] Hein E, Nowak M, Kiess O, Biermann T, Bayerlein K, Kornhuber J, et al. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm 2013;120:821e7. https:// doi.org/10.1007/s00702-012-0908-6.

                    

[31] Huang F, Dong J, Kong J, Wang H, Meng H, Spaeth RB, et al. Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study. BMC Compl Alternative Med 2014;14:203. https:// doi.org/10.1186/1472-6882-14-203.

                    

[32] Jacobs HIL, Riphagen JM, Razat CM, Wiese S, Sack AT. Transcutaneous vagus nerve stimulation boosts associative memory in older individuals. Neurobiol Aging 2015;36:1860e7. https://doi.org/10.1016/ j.neurobiolaging.2015.02.023.

                    

[33] Kinfe TM, Pintea B, Güresir E, Vatter H. Brain stimulation partial response of intractable cluster-tic syndrome treated by cervical non-invasive vagal nerve stimulation ( nVNS ). Brain Stimul 2015;8:3e5. https://doi.org/10.1016/ j.brs.2015.01.002.

                    

[34] Kinfe TM, Pintea B, Muhammad S, Zaremba S, Roeske S, Simon BJ, et al. Cervical non-invasive vagus nerve stimulation (nVNS) for preventive and acute treatment of episodic and chronic migraine and migraine-associated sleep disturbance: preliminary findings from a prospective observational cohort study. J Headache Pain 2015;16:101. https://doi.org/10.1186/s10194-015- 0582-9.

                    

[35] KrausT,Ho€slK,Kiess O,Schanze A,Kornhuber J,Forster C .BOLD fMRI deactivation of limbic and temporal brain structures and mood enhancing effect by transcutaneous vagus nerve stimulation. J Neural Transm 2007;114: 1485e93. https://doi.org/10.1007/s00702-007-0755-z.

                    

[36] Kreuzer PPM, Landgrebe M, Resch M, Husser O, Schecklmann M, Geisreiter F, et al. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study. Brain Stimul 2014;7(14):00173e9. https://doi.org/10.1016/j.brs.2014.05.003. pii: S1935-861X.

                    

[37] Laqua R, Leutzow B, Wendt M, Usichenko T. Transcutaneous vagal nerve stimulation may elicit anti- and pro-nociceptive effects under experimentally- induced pain - a crossover placebo-controlled investigation. Auton Neurosci 2014;185:120e2. https://doi.org/10.1016/j.autneu.2014.07.008.

                    

[38] Lehtimaki J, Hyvarinen P, Ylikoski M, Bergholm M, M€akel€a JP, Aarnisalo A, et al. Transcutaneous vagus nerve stimulation in tinnitus: a pilot study. Acta Otolaryngol 2013;133:378e82. https://doi.org/10.3109/ 00016489.2012.750736.

                    

[39] Lerman I, Hauger R, Sorkin L, Proudfoot J, Davis B, Huang A, et al. Noninvasive transcutaneous vagus nerve stimulation decreases whole blood culture- derived cytokines and chemokines: a randomized, blinded, healthy control pilot trial. Neuromodulation Technol Neural Interface 2016;19:283e90. https://doi.org/10.1111/ner.12398.

                    

[40] MagisD,Ge rardP,Schoenen J.Transcutaneous Vagus Nerve Stimulation (tVNS) for headache prophylaxis: initial experience. J Headache Pain 2013;14: P198. https://doi.org/10.1186/1129-2377-14-S1-P198.

                    

[41] Marin J, Consiglio E, McClure C, Liebler E. NON-INVASIVE vagus nerve stimulation (nvns) for treatment of cluster headache: EARLY UK clinical experience. Cephalalgia 2016;36:99e100.

                    

[42] Napadow V, Edwards RR, Cahalan CM, Mensing G, Greenbaum S, Valovska A, et al. Evoked pain analgesia in chronic pelvic pain patients using respiratory- gated auricular. Pain Med 2012;13:777e89. https://doi.org/10.1111/j.1526- 4637.2012.01385.x.

                    

[43] Paulon E, Nastou D, Jaboli MF, Epstein O. Non-invasive afferent vagus nerve stimulation (nvns) using gammacore (gc) in patients with treatment refractory gastroparesis awaiting enterra gastric neurostimulation. Gut 2015;64(Suppl):A35.

                    

[44] Rong P, Liu A, Zhang J, Wang Y, Yang A, Li LL, et al. An alternative therapy for drug-resistant epilepsy: transcutaneous auricular vagus nerve stimulation. Chin Med J (Taipei) 2014;127:300e4.

                    

[45] Rong P, Liu J, Wang L, Liu R, Fang J, Zhao J, et al. Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder: a non- randomized controlled pilot study. J Affect Disord 2016;195:172e9. https:// doi.org/10.1016/j.jad.2016.02.031.

                    

[46] Schulz-Stübner S, Kehl F. Treatment of persistent hiccups with transcutaneous phrenic and vagal nerve stimulation. Intensive Care Med 2011;37:1048e9. https://doi.org/10.1007/s00134-011-2150-3.

                    

[47] Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, et al. Chronic migraine headache prevention with non invasive vagus nerve stimulation. Neurology 2016;87:529e38. https://doi.org/10.1212/ WNL.0000000000002918.

                    

[48] Silberstein SD, Mechtler LL, Kudrow DB, Calhoun AH, McClure C, Saper JR, et al. Non-invasive vagus nerve stimulation for the ACute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study. Headache 2016;56:1317e32. https://doi.org/10.1111/ head.12896.

                    

[49] Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, et al. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol 2015;65:867e75. https://doi.org/10.1016/ j.jacc.2014.12.026.

                

[50]  Steenbergen L, Sellaro R, Stock A-K, Verkuil B, Beste C, Colzato LS. Transcutaneous vagus nerve stimulation (tVNS) enhances response selection during action cascading processes. Eur Neuropsychopharmacol 2015. https://doi.org/ 10.1016/j.euroneuro.2015.03.015.

                        

[51]  Stefan H, Kreiselmeyer G, Kerling F, Kurzbuch K, Rauch C, Heers M, et al. Transcutaneous vagus nerve stimulation (t-VNS) in pharmacoresistant epilepsy: a proof of concept trial. Epilepsia 2012;53:e115e8. https://doi.org/ 10.1111/j.1528-1167.2012.03492.x.

                        

[52]  Steyn E, Mohamed Z, Husselman C. Non-invasive vagus nerve stimulation for the treatment of acute asthma exacerbations results from an initial case series. Int J Emerg Med 2013;6:7. https://doi.org/10.1186/1865-1380-6-7.

                        

[53]  Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain 2015;16:543. https://doi.org/10.1186/s10194-015-0543-3.

                        

[54]  Trevizol AP, Taiar I, Barros MD, Liquidatto B, Cordeiro Q, Shiozawa P. Transcutaneous vagus nerve stimulation (tVNS) protocol for the treatment of major depressive disorder: a case study assessing the auricular branch of the vagus nerve. Epilepsy Behav 2015;53:166e7. https://doi.org/10.1016/ j.yebeh.2015.10.002.

                        

[55]  Trevizol AP, Shiozawa P, Taiar I, Soares A, Gomes JS, Barros MD, et al. Transcutaneous vagus nerve stimulation (taVNS) for major depressive disorder: an open label proof-of-concept trial. Brain Stimul 2016;9:453e4. https://doi.org/ 10.1016/j.brs.2016.02.001.

 

[56] Clancy JA, Mary DA, Witte KK, Greenwood JP, Deuchars SA, Deuchars J. Non- invasive vagus nerve stimulation in healthy humans reduces sympathetic nerve activity. Brain Stimul 2014;7:871e7. https://doi.org/10.1016/ j.brs.2014.07.031.

                    

[57] Frangos E, Komisaruk BR. Access to vagal projections via cutaneous electrical stimulation of the neck: fMRI evidence in healthy humans. Brain Stimul 2017;10:19e27. https://doi.org/10.1016/j.brs.2016.10.008.

                    

[58] Frøkjaer JB, Bergmann S, Brock C, Madzak A, Farmer AD, Ellrich J, et al. Modulation of vagal tone enhances gastroduodenal motility and reduces somatic pain sensitivity. Neurogastroenterol Motil 2016;28:592e8. https:// doi.org/10.1111/nmo.12760.

                    

[59] Garcia, R., Lin, R., Lee, J., Loggia, M., Kim, J., Kim, H., Wasan, A., Edwards, R., Hadjikhani, N. and Napadow V. Brainstem activity and connectivity is modulated by respiratory-gated auricular vagus afferent nerve stimulation (RAVANS) in migraine patients an fMRI study. J Pain n.d.;17(4):S73eS74.

                    

[60] Weise D, Adamidis M, Pizzolato F, Rumpf J-J, Fricke C, Classen J. Assessment of brainstem function with auricular branch of vagus nerve stimulation in Parkinson's disease. PLoS One 2015;10. https://doi.org/10.1371/journal.- pone.0120786. e0120786.

                    

[61] Kreuzer PM, Landgrebe M, Husser O, Resch M, Schecklmann M, Geisreiter F, et al. Transcutaneous vagus nerve stimulation: retrospective assessment of cardiac safety in a pilot study. Front Psychiatr 2012;3:70. https://doi.org/ 10.3389/fpsyt.2012.00070.