Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China
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 pos...
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BMJ Publishing Group
2024-05-01
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| Online Access: | https://bmjopen.bmj.com/content/14/5/e083888.full |
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| author | Jan D Reinhardt Jin Liu Ting Luo Xiao Lu Zhen-Yu Liu Long-yun Zhou Li-jun Peng Ya-feng Liu Shu-wei Wang Yue Qiu Si-jing Chen Ming-ming Feng Shan-shan Wu Hui-juan Wu Jiang-ping Ge |
| author_facet | Jan D Reinhardt Jin Liu Ting Luo Xiao Lu Zhen-Yu Liu Long-yun Zhou Li-jun Peng Ya-feng Liu Shu-wei Wang Yue Qiu Si-jing Chen Ming-ming Feng Shan-shan Wu Hui-juan Wu Jiang-ping Ge |
| author_sort | Jan D Reinhardt |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c703b690e9d047eba0afa631fd6e46c1 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c703b690e9d047eba0afa631fd6e46c12025-08-20T02:40:33ZengBMJ Publishing GroupBMJ Open2044-60552024-05-0114510.1136/bmjopen-2024-083888Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in ChinaJan D Reinhardt0Jin Liu1Ting Luo2Xiao Lu3Zhen-Yu Liu4Long-yun Zhou5Li-jun Peng6Ya-feng Liu7Shu-wei Wang8Yue Qiu9Si-jing Chen10Ming-ming Feng11Shan-shan Wu12Hui-juan Wu13Jiang-ping Ge148 Department of Health Sciences and Medicine, University of Lucerne, Lucerne, SwitzerlandDepartment of Neurology, Chongqing University Three Gorges Hospital, Chongqing, ChinaDepartment of Medical Oncology of Cancer Center, West China Hospital, Sichuan University, Chengdu, China1 Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People`s Republic of China1 Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People`s Republic of China1 Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People`s Republic of China1 Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People`s Republic of China2 Department of Critical Care Medicine, Nanjing Zijin Hospital, Nanjing, People`s Republic of China3 Department of Critical Care Medicine, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, People`s Republic of China1 Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People`s Republic of China1 Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People`s Republic of China2 Department of Critical Care Medicine, Nanjing Zijin Hospital, Nanjing, People`s Republic of China2 Department of Critical Care Medicine, Nanjing Zijin Hospital, Nanjing, People`s Republic of China3 Department of Critical Care Medicine, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, People`s Republic of China6 Nanjing Zijin Hospital, Nanjing, People`s Republic of ChinaIntroduction 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.https://bmjopen.bmj.com/content/14/5/e083888.full |
| spellingShingle | Jan D Reinhardt Jin Liu Ting Luo Xiao Lu Zhen-Yu Liu Long-yun Zhou Li-jun Peng Ya-feng Liu Shu-wei Wang Yue Qiu Si-jing Chen Ming-ming Feng Shan-shan Wu Hui-juan Wu Jiang-ping Ge Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China BMJ Open |
| title | Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China |
| title_full | Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China |
| title_fullStr | Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China |
| title_full_unstemmed | Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China |
| title_short | Transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness (TAVREC): study protocol for a multicenter, triple-blind, randomized controlled trial in China |
| title_sort | transcutaneous auricular vagal nerve stimulation for consciousness recovery in patients with prolonged disorders of consciousness tavrec study protocol for a multicenter triple blind randomized controlled trial in china |
| url | https://bmjopen.bmj.com/content/14/5/e083888.full |
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