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

BMC Complementary and Alternative Medicine

Jian Kong³  Bing Zhu⁴  Xia Li²  Yu-Feng Zhao¹  Zhan-Xia Huang²  Ru-Peng Liu⁴  Liang Li⁴  Hui Ben⁴  Ying-ge Ma²  Jun Liu⁶  Hong Meng⁴  Li-Ping Wang⁵  Ji-Liang Fang⁶  Pei-Jing Rong⁴ 

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

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

Others  :  1231370
DOI  :  10.1186/1472-6882-12-255

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

【 摘 要 】

Background

Depressive 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.

Design

One 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.

Discussion

This 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 registration

Clinical Trials. ChiCTR-TRC-11001201 http://www.chictr.org/cn/ webcite

【 授权许可】

   
2012 Rong et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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