METHODS: 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.
BACKGROUND: 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.
BACKGROUND: ChiCTR2300073950.
方法:TAVREC程序是一个多中心,三盲,4周干预后4周随访的随机对照试验.将招募至少116名合格的pDoC患者,并随机接受以下任意一项:(1)常规治疗加taVNS(30s单相平方电流,脉冲宽度为300μs,频率为25Hz,强度为1mA,然后休息30s,60分钟,一天两次,4周);或(2)常规治疗加taVNS安慰剂。TAVREC的主要结果是基于第4周的昏迷恢复量表(CRS-R)的意识水平改善率。次要结果是CRS-R总分和子量表得分,格拉斯哥昏迷评分,无响应得分的完整轮廓,心电图参数,脑干听觉诱发电位,上体感诱发电位,来自正电子发射断层扫描/功能MRI的神经成像参数,与意识水平和不良事件相关的血清生物标志物。
背景:本研究经南京医科大学第一附属医院研究伦理委员会审查批准(参考号:2023-SR-392)。研究结果将在同行评审的期刊上传播,并在相关会议上发表。
背景:ChiCTR2300073950。