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

BMC Complementary and Alternative Medicine

Study Protocol

Zhan-Xia Huang¹  Xia Li¹  Ying-ge Ma¹  Yu-Feng Zhao²  Jian Kong³  Jun Liu⁴  Li-Ping Wang⁵  Pei-Jing Rong⁶  Hong Meng⁶  Hui Ben⁶  Liang Li⁶  Ru-Peng Liu⁶  Bing Zhu⁶  Ji-Liang Fang⁷ 

[1] Beijing University of Chinese Medicine, 100029, Beijing, China;Clinical Evaluation Center, China Academy of Chinese Medical Sciences, 100700, Beijing, China;Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 02115, Boston, MA, USA;Guang An Men Hospital, China Academy of Chinese Medical Sciences, 100053, Beijing, China;Huguosi TCM Hospital, Beijing University of TCM, Beijing, China;Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, 100700, Beijing, China;Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, 100700, Beijing, China;Guang An Men Hospital, China Academy of Chinese Medical Sciences, 100053, Beijing, China;

关键词: Major depression disorder;    Vagus nerve stimulation;    Transcutanecous vagus nerve stimulation;   

DOI  :  10.1186/1472-6882-12-255

 received in 2012-09-16, accepted in 2012-11-23,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundDepressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD) is far from satisfactory. Vagus nerve stimulation (VNS) is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response.This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention.DesignOne hundred twenty cases (60 males) of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS) and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period.DiscussionThis study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of methodologies in clinical trials of acupuncture treatment.Trials registrationClinical Trials. ChiCTR-TRC-11001201 http://www.chictr.org/cn/

【 授权许可】

CC BY   
© Rong et al.; licensee BioMed Central Ltd. 2012