Effects of simultaneous transcutaneous auricular vagus nerve stimulation and high-definition transcranial direct current stimulation on disorders of consciousness: a study protocol

Yutong Zhuang; Weihang Zhai; Qinghua Li; Haoyang Jiao; Qianqian Ge; Peijing Rong; Jianghong He

doi:10.3389/fneur.2023.1165145

Effects of simultaneous transcutaneous auricular vagus nerve stimulation and high-definition transcranial direct current stimulation on disorders of consciousness: a study protocol

Front Neurol. 2023 Aug 24:14:1165145. doi: 10.3389/fneur.2023.1165145. eCollection 2023.

Authors

Yutong Zhuang^{1

2}, Weihang Zhai³, Qinghua Li⁴, Haoyang Jiao⁵, Qianqian Ge¹, Peijing Rong³, Jianghong He¹

Affiliations

¹ Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
² Department of Neurosurgery, The Second Clinical College of Southern Medical University, Guangzhou, China.
³ Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.
⁴ College of Anesthesiology, Shanxi Medical University, Taiyuan, China.
⁵ Institute of Documentation, Chinese Academy of Traditional Chinese Medicine, Beijing, China.

Abstract

Background: Non-invasive brain stimulation (NIBS) techniques are now widely used in patients with disorders of consciousness (DOC) for accelerating their recovery of consciousness, especially minimally conscious state (MCS). However, the effectiveness of single NIBS techniques for consciousness rehabilitation needs further improvement. In this regard, we propose to enhance from bottom to top the thalamic-cortical connection by using transcutaneous auricular vagus nerve stimulation (taVNS) and increase from top to bottom cortical-cortical connections using simultaneous high-definition transcranial direct current stimulation (HD-tDCS) to reproduce the network of consciousness.

Methods/design: The study will investigate the effect and safety of simultaneous joint stimulation (SJS) of taVNS and HD-tDCS for the recovery of consciousness. We will enroll 84 MCS patients and randomize them into two groups: a single stimulation group (taVNS and HD-tDCS) and a combined stimulation group (SJS and sham stimulation). All patients will undergo a 4-week treatment. The primary outcome will be assessed using the coma recovery scale-revised (CRS-R) at four time points to quantify the effect of treatment: before treatment (T0), after 1 week of treatment (T1), after 2 weeks of treatment (T2), and after 4 weeks of treatment (T3). At the same time, nociception coma scale-revised (NCS-R) and adverse effects (AEs) will be collected to verify the safety of the treatment. The secondary outcome will involve an analysis of electroencephalogram (EEG) microstates to assess the response mechanisms of dynamic brain networks to SJS. Additionally, CRS-R and AEs will continue to be obtained for a 3-month follow-up (T4) after the end of the treatment.

Discussion: This study protocol aims to innovatively develop a full-time and multi-brain region combined neuromodulation paradigm based on the mesocircuit model to steadily promote consciousness recovery by restoring thalamocortical and cortical-cortical interconnections.

Keywords: EEG microstate; disorders of consciousness; high-definition transcranial direct current stimulation; simultaneous stimulation; transcutaneous auricular vagus nerve stimulation.