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Abstract：
BACKGROUND: 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: 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.
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.
摘要：
背景：长期意识障碍（pDoC）是脑损伤后的灾难性疾病，治疗选择很少。经皮耳迷走神经刺激（taVNS），一个保险箱,非侵入性干预调节丘脑-皮层连通性和脑功能，是pDoC的可能治疗选择。我们开发了一项随机对照研究的方案，以评估taVNS对pDoC（TAVREC）患者意识恢复的有效性。
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。
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。
