Transcutaneous vagus nerve stimulation for the treatment of depression: A study protocol for a double blinded randomized clinical trial

BMC Complementary and Alternative Medicine

Volumn 12, Issue , 2012, Pages

  Rong, Pei Jing ^a   Fang, Ji Liang ^a   Wang, Li Ping ^c   Meng, Hong ^a   Liu, Jun ^a   Ma, Ying ge ^c   Ben, Hui ^a   Li, Liang ^a   Liu, Ru Peng ^a   Huang, Zhan Xia ^c   Zhao, Yu Feng ^a   Li, Xia ^c   Zhu, Bing ^a   Kong, Jian ^b  

^a INSTITUTE OF CHINESE MATERIA MEDICA   (China)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c BEIJING UNIVERSITY OF CHINESE MEDICINE   (China)

Author keywords

Major depression disorder; Transcutanecous vagus nerve stimulation; Vagus nerve stimulation

Indexed keywords

ARTICLE; BIPOLAR DISORDER; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; EPILEPSY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MORBID OBESITY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; TRANSCUTANEOUS NERVE STIMULATION; VAGUS NERVE STIMULATION;

ADOLESCENT; ADULT; AGED; CHILD; CLINICAL PROTOCOLS; DEPRESSIVE DISORDER; EAR; HUMANS; MALE; MIDDLE AGED; RESEARCH DESIGN; VAGUS NERVE; VAGUS NERVE STIMULATION; YOUNG ADULT;

EID: 84870936445     PISSN: None     EISSN: 14726882     Source Type: Journal    
DOI: 10.1186/1472-6882-12-255     Document Type: Article

References (26)

1. Sackeim HA, Lisanby SH. physical treatments in psychiatry. Treatment of depression: bridging the 21 st century 2001, 151-172. Washington, DC: American psychiatric press, Weissman MM.
2. Michaud CM, Murray CJ, Bloom BR. Burden of disease-implications for future research. JAMA 2001, 285:535-539. 10.1001/jama.285.5.535, 11176854.
3. Rush AJ. Vagus nerve stimulation: clinical results in depression. Vagus nerve stimulaiton 2003, 85-112. London: Martin Dunitz, Schachter SC, Schmidt D.
4. George MS, Nahas Z, Bohning DE, Kozel FA, Anderson B, Chae JH, Li XB, Mu QW. Potential mechanisms of action of vagus nerve stimulaiton for depression. Vagus nerve stimulaiton 2003, 68-83. London: Martin Dunitz, Schachter SC, Schmidt D.
5. Nemeroff CB, Mayberg HS, Krahl SE, McNamara J, Frazer A, Henry TR, George MS, Charney DS, Brannan SK. VNS therapy in treatment-resistant depression: clinical evidence and putative neurobiological mechanisms. Neuropsychopharmacology 2006, 31:1345-1355. 10.1038/sj.npp.1301082, 16641939.
6. Daban C, Martinez-Aran A, Cruz N, Vieta E. Safety and efficacy of Vagus Nerve Stimulation in treatment-resistant depression. A systematic review. J Affect Disord 2008, 110:1-15. 10.1016/j.jad.2008.02.012, 18374988.
7. Sperling W, Reulbach U, Kornhuber J. Clinical benefits and cost effectiveness of vagus nerve stimulation in a long-term treatment of patients with major depression. Pharmacopsychiatry 2009, 42:85-88. 10.1055/s-0028-1103294, 19452375.
8. Ventureyra EC. Transcutaneous vagus nerve stimulation for partial onset seizure therapy. A new concept. Childs Nerv Syst 2000, 16:101-102. 10.1007/s003810050021, 10663816.
9. Henry TR. Therapeutic mechanisms of vagus nerve stimulation. Neurology 2002, 59:S3-S14.
10. Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat 2002, 15:35-37. 10.1002/ca.1089, 11835542.
11. Yang AC, Zhang JG, Rong PJ, Liu HG, Chen N, Zhu B. A new choice for the treatment of epilepsy: electrical auricula-vagus-stimulation. Med Hypotheses 2011, 77:244-245. 10.1016/j.mehy.2011.04.021, 21601370.
12. Rush AJ, Marangell LB, Sackeim HA, George MS, Brannan SK, Davis SM, Howland R, Kling MA, Rittberg BR, Burke WJ, et al. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry 2005, 58:347-354. 10.1016/j.biopsych.2005.05.025, 16139580.
13. Rush AJ, Sackeim HA, Marangell LB, George MS, Brannan SK, Davis SM, Lavori P, Howland R, Kling MA, Rittberg B, et al. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study. Biol Psychiatry 2005, 58:355-363. 10.1016/j.biopsych.2005.05.024, 16139581.
14. Jensen MP, Karoly P. Motivation and expectancy factor in symptom perception: a laboratory study of the placebo effect. Psychosom Med 1991, 53:144-152.
15. Fillmore M, Vogel-Sprott M. Expected effect of caffeine on motor performance predicts the type of response to placebo. Pharmacol 1992, 106:209-214.
16. Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA. Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects. Spine 2001, 26:1418-1424. 10.1097/00007632-200107010-00005, 11458142.
17. Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance?. Ann Intern Med 2002, 136:817-825.
18. Xu WW, Li JX, Cai Y, Wang QS. Study of vagus nerve in ear electronic acupunc ture stimulation for senior patients w ith treatment-resistantmajor depressive. J C lin Psych iatry 2009, 19:189-200.
19. Mohr P, Rodriguez M, Slavickova A, Hanka J. The application of vagus nerve stimulation and deep brain stimulation in depression. Neuropsychobiology 2011, 64:170-181. 10.1159/000325225, 21811087.
20. Stefan H, Kreiselmeyer G, Kerling F, Kurzbuch K, Rauch C, Heers M, Kasper BS, Hammen T, Rzonsa M, Pauli E, et al. Transcutaneous vagus nerve stimulation (t-VNS) in pharmacoresistant epilepsies: a proof of concept trial. Epilepsia 2012, 53:e115-e118. 10.1111/j.1528-1167.2012.03492.x, 22554199.
21. Kraus T, Hosl K, 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, 114:1485-1493. 10.1007/s00702-007-0755-z, 17564758.
22. Henry TR, Bakay RA, Votaw JR, Pennell PB, Epstein CM, Faber TL, Grafton ST, Hoffman JM. Brain blood flow alterations induced by therapeutic vagus nerve stimulation in partial epilepsy: I. Acute effects at high and low levels of stimulation. Epilepsia 1998, 39:983-990.
23. Henry TR, Bakay RA, Pennell PB, Epstein CM, Votaw JR. Brain blood-flow alterations induced by therapeutic vagus nerve stimulation in partial epilepsy: II. prolonged effects at high and low levels of stimulation. Epilepsia 2004, 45:1064-1070. 10.1111/j.0013-9580.2004.03104.x, 15329071.
24. Zobel A, Joe A, Freymann N, Clusmann H, Schramm J, Reinhardt M, Biersack HJ, Maier W, Broich K. Changes in regional cerebral blood flow by therapeutic vagus nerve stimulation in depression: an exploratory approach. Psychiatry Res 2005, 139:165-179. 10.1016/j.pscychresns.2005.02.010, 16043331.
25. Gao XY, Li YH, Zhu B, Ben H, Rong PJ. Effect of acupuncture of auricular concha area on blood pressure in spontaneous hyertension and norma rats and its underlying mechanim. Chinese Acupuncture 2006, 31:90-95.
26. Gao XY, Zhang SP, Zhu B, Zhang HQ. Investigation of specificity of auricular acupuncture points in regulation of autonomic function in anesthetized rats. Auton Neurosci 2008, 138:50-56. 10.1016/j.autneu.2007.10.003, 18068545.