Acute traumatic coma awakening by right median nerve electrical stimulation: a randomised controlled trial.

Autor: Wu X; Department of Neurosurgery, Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China., Xie L; Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Lei J; Department of Neurosurgery, Tongji Hospital, Tongji Medical College of HUST, Wuhan, China., Yao J; Department of Neurosurgery, The Second People's Hospital of Nanning, Nanning, China., Li J; Department of Neurosurgery, Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Foshan, China., Ruan L; Department of Neurosurgery, The People's Hospital of PingYang, Pingyang, China., Hong J; Department of Neurosurgery, Tangshan Gongren Hospital, Tangshan, China., Zheng G; Department of Neurosurgery, Linyi People's Hospital, Linyi, China., Cheng Y; Department of Neurosurgery, Changzhi Second People's Hospital, Changzhi, China., Long L; Department of Neurosurgery, South Taihu Hospital, Huzhou, China., Wang J; Department of Neurosurgery, The Third Affiliated Hospital of PLA Navy Military Medical University, Shanghai, China., Huang C; Department of Neurosurgery, The 421st Hospital of Chinese People's Liberation Army, Guangzhou, China., Xie Q; Department of Neurosurgery, Guangzhou General Hospital of Guangzhou Military Region, Guangzhou, China., Zhang X; Department of Neurosurgery, Lishui City People's Hospital, Lishui, China., He J; Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China., Yu X; Department of Neurosurgery, Shaoxing People's Hospital, Shaoxing, China., Lv S; Department of Neurosurgery, Tengzhou City Center People's Hospital, Tengzhou, China., Sun Z; Department of Neurosurgery, Harrison International Peace Hospital, Hengshui, China., Liu D; Department of Neurosurgery, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huaian, China., Li X; Department of Neurosurgery, The Brain Hospital of Hunan Province, Changsha, China., Zhu J; Department of Neurosurgery, Liaocheng Brain Hospital, Liaocheng, China., Yang X; Department of Neurosurgery, Baoji 3rd Hospital of Chinese People's Liberation Army, Baoji, China., Wang D; Department of Neurosurgery, Yanjiao People's Hospital, Sanhe, China., Bao Y; Department of Neurosurgery, The Fourth Affiliated Hospital of China Medical University, Shenyang, China., Maas AIR; Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium.; University of Antwerp, Edegem, Belgium., Menon D; Division of Anesthesia, Department of Medicine, University of Cambridge, Cambridge, UK., Xue Y; Department of Neurosurgery, Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China., Jiang J; Brain Injury Centre, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.; Shanghai Institute of Head Trauma, Shanghai, China., Feng J; Brain Injury Centre, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.; Shanghai Institute of Head Trauma, Shanghai, China., Gao G; Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China. gao3@sina.com.; Department of Neurosurgery, Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. gao3@sina.com.; Shanghai Institute of Head Trauma, Shanghai, China. gao3@sina.com.
Jazyk: angličtina
Zdroj: Intensive care medicine [Intensive Care Med] 2023 Jun; Vol. 49 (6), pp. 633-644. Date of Electronic Publication: 2023 May 13.
DOI: 10.1007/s00134-023-07072-1
Abstrakt: Purpose: Severe traumatic brain injury (TBI) leads to acute coma and may result in prolonged disorder of consciousness (pDOC). We aimed to determine whether right median nerve electrical stimulation is a safe and effective treatment for accelerating emergence from coma after TBI.
Methods: This randomised controlled trial was performed in 22 centres in China. Participants with acute coma at 7-14 days after TBI were randomly assigned (1:1) to either routine therapy and right median nerve electrical stimulation (RMNS group) or routine treatment (control group). The RMNS group received 20 mA, 300 μs, 40 Hz stimulation pulses, lasting 20 s per minutes, 8 h per day, for 2 weeks. The primary outcome was the proportion of patients who regained consciousness 6 months post-injury. The secondary endpoints were Glasgow Coma Scale (GCS), Full Outline of Unresponsiveness scale (FOUR), Coma Recovery Scale-Revised (CRS-R), Disability Rating Scale (DRS) and Glasgow Outcome Scale Extended (GOSE) scores reported as medians on day 28, 3 months and 6 months after injury, and GCS and FOUR scores on day 1 and day 7 during stimulation. Primary analyses were based on the intention-to-treat set.
Results: Between March 26, 2016, and October 18, 2020, 329 participants were recruited, of whom 167 were randomised to the RMNS group and 162 to the control group. At 6 months post-injury, a higher proportion of patients in the RMNS group regained consciousness compared with the control group (72.5%, n = 121, 95% confidence interval (CI) 65.2-78.7% vs. 56.8%, n = 92, 95% CI 49.1-64.2%, p = 0.004). GOSE at 3 months and 6 months (5 [interquartile range (IQR) 3-7] vs. 4 [IQR 2-6], p = 0.002; 6 [IQR 3-7] vs. 4 [IQR 2-7], p = 0.0005) and FOUR at 28 days (15 [IQR 13-16] vs. 13 [interquartile range (IQR) 11-16], p = 0.002) were significantly increased in the RMNS group compared with the control group. Trajectory analysis showed that significantly more patients in the RMNS group had faster GCS, CRS-R and DRS improvement (p = 0.01, 0.004 and 0.04, respectively). Adverse events were similar in both groups. No serious adverse events were associated with the stimulation device.
Conclusion: Right median nerve electrical stimulation is a possible effective treatment for patients with acute traumatic coma, that will require validation in a confirmatory trial.
(© 2023. The Author(s).)
Databáze: MEDLINE
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