Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.
Department of Critical Care Medicine, Nanjing Zijin Hospital, Nanjing, People's Republic of China.
BMJ Open. 2024 May 31;14(5):e083888. doi: 10.1136/bmjopen-2024-083888.
INTRODUCTION: Prolonged disorders of consciousness (pDoC) are a catastrophic condition following brain injury with few therapeutic options. Transcutaneous auricular vagal nerve stimulation (taVNS), a safe, non-invasive intervention modulating thalamo-cortical connectivity and brain function, is a possible treatment option of pDoC. We developed a protocol for a randomised controlled study to evaluate the effectiveness of taVNS on consciousness recovery in patients with pDoC (TAVREC). METHODS AND ANALYSIS: The TAVREC programme is a multicentre, triple-blind, randomised controlled trial with 4 weeks intervention followed by 4 weeks follow-up period. A minimum number of 116 eligible pDoC patients will be recruited and randomly receive either: (1) conventional therapy plus taVNS (30 s monophasic square current of pulse width 300 μs, frequency of 25 Hz and intensity of 1 mA followed by 30 s rest, 60 min, two times per day, for 4 weeks); or (2) conventional therapy plus taVNS placebo. Primary outcome of TAVREC is the rate of improved consciousness level based on the Coma Recovery Scale-Revised (CRS-R) at week 4. Secondary outcomes are CRS-R total and subscale scores, Glasgow Coma Scale score, Full Outline of UnResponsiveness score, ECG parameters, brainstem auditory evoked potential, upper somatosensory evoked potential, neuroimaging parameters from positron emission tomography/functional MRI, serum biomarkers associated with consciousness level and adverse events. ETHICS AND DISSEMINATION: This study was reviewed and approved by the Research Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (Reference number: 2023-SR-392). Findings will be disseminated in a peer-reviewed journal and presented at relevant conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300073950.
简介:持续性意识障碍(pDoC)是一种脑损伤后的灾难性状态,治疗选择有限。经皮耳迷走神经刺激(taVNS)是一种安全、非侵入性的干预措施,可以调节丘脑-皮质连接和大脑功能,是治疗 pDoC 的一种可能选择。我们制定了一项随机对照研究方案,以评估 taVNS 对 pDoC 患者意识恢复的有效性(TAVREC)。
方法和分析:TAVREC 计划是一项多中心、三盲、随机对照试验,干预期为 4 周,随访期为 4 周。将招募至少 116 名符合条件的 pDoC 患者,并随机接受以下两种治疗之一:(1)常规治疗加 taVNS(30 秒单相方波电流,脉冲宽度 300μs,频率 25Hz,强度 1mA,随后 30 秒休息,60 分钟,每天两次,持续 4 周);或(2)常规治疗加 taVNS 安慰剂。TAVREC 的主要结局是根据修订后的昏迷恢复量表(CRS-R)在第 4 周时意识水平改善的比率。次要结局是 CRS-R 总分和子量表评分、格拉斯哥昏迷量表评分、完全无反应量表评分、心电图参数、脑干听觉诱发电位、体感诱发电位、正电子发射断层扫描/功能磁共振成像的神经影像学参数、与意识水平相关的血清生物标志物和不良事件。
伦理和传播:本研究已由南京医科大学第一附属医院伦理委员会审查和批准(编号:2023-SR-392)。研究结果将在同行评议的期刊上发表,并在相关会议上展示。
试验注册号:ChiCTR2300073950。