Evidence map›Paper›PMID 37178149›Full record

Trial reportIntensive care medicine2023

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

Xiang Wu, Li Xie, Jin Lei, Jiemin Yao, Jiarong Li, Lixin Ruan, Jun Hong, Guodong Zheng, Yangyu Cheng, Liansheng Long and 21 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Intensive care medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07077135 (Transcutaneous Vagal Nerve Stimulation to Treat Disorders of Consciousness), which is not on this map. Cited by 30 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 5 pooled it
9.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07077135 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Transcutaneous Vagal Nerve Stimulation to Treat Disorders of Consciousness

TypeinterventionalSponsorFondazione IRCCS San Gerardo dei TintoriRan2025 to 2028Enrolled106ConditionsDisorder of ConsciousnessArmsstimulated group, Sham (No Treatment)
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 5 syntheses or guidelines pooled it, 42 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 3 countries.

Xiang Wu *Department of Neurosurgery, Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Li Xie *Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jin Lei *Department of Neurosurgery, Tongji Hospital, Tongji Medical College of HUST, Wuhan, China.
Jiemin YaoDepartment of Neurosurgery, The Second People's Hospital of Nanning, Nanning, China.
Jiarong LiDepartment of Neurosurgery, Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Foshan, China.
Lixin RuanDepartment of Neurosurgery, The People's Hospital of PingYang, Pingyang, China.
Jun HongDepartment of Neurosurgery, Tangshan Gongren Hospital, Tangshan, China.
Guodong ZhengDepartment of Neurosurgery, Linyi People's Hospital, Linyi, China.
Yangyu ChengDepartment of Neurosurgery, Changzhi Second People's Hospital, Changzhi, China.
Liansheng LongDepartment of Neurosurgery, South Taihu Hospital, Huzhou, China.
Jiancun WangDepartment of Neurosurgery, The Third Affiliated Hospital of PLA Navy Military Medical University, Shanghai, China.
Chuanping HuangDepartment of Neurosurgery, The 421st Hospital of Chinese People's Liberation Army, Guangzhou, China.
Qiuyou XieDepartment of Neurosurgery, Guangzhou General Hospital of Guangzhou Military Region, Guangzhou, China.
Xuelei ZhangDepartment of Neurosurgery, Lishui City People's Hospital, Lishui, China.
Jianghong HeDepartment of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.
Xuebin YuDepartment of Neurosurgery, Shaoxing People's Hospital, Shaoxing, China.
Shouhua LvDepartment of Neurosurgery, Tengzhou City Center People's Hospital, Tengzhou, China.
Zhaosheng SunDepartment of Neurosurgery, Harrison International Peace Hospital, Hengshui, China.
Dai LiuDepartment of Neurosurgery, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huaian, China.
Xin LiDepartment of Neurosurgery, The Brain Hospital of Hunan Province, Changsha, China.
Jianxin ZhuDepartment of Neurosurgery, Liaocheng Brain Hospital, Liaocheng, China.
Xiaoliang YangDepartment of Neurosurgery, Baoji 3rd Hospital of Chinese People's Liberation Army, Baoji, China.
Dongdong WangDepartment of Neurosurgery, Yanjiao People's Hospital, Sanhe, China.
Yijun BaoDepartment of Neurosurgery, The Fourth Affiliated Hospital of China Medical University, Shenyang, China.
Andrew I R MaasDepartment of Neurosurgery, Antwerp University Hospital, Edegem, Belgium.
David MenonDivision of Anesthesia, Department of Medicine, University of Cambridge, Cambridge, UK.
Yajun Xue *Department of Neurosurgery, Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jiyao JiangBrain Injury Centre, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Junfeng Feng *Brain Injury Centre, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Guoyi Gao *Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China. gao3@sina.com.ORCID 0000-0003-2090-8369
ACES Participants
Shanghai Jiao Tong University · CNHejian People's Hospital · CNHuaian First People’s Hospital · CNLishui City People's Hospital · CNXian Yang Central Hospital · CNCapital Medical University · CNFourth Affiliated Hospital of China Medical University · CNGeneral Hospital of Guangzhou Military Command · CNLinyi People's Hospital · CNThe Second Nanning People's Hospital · CNChinese People's Liberation Army · CNHarrison International Peace Hospital · CNHunan Institute of Mental Health · CNIntegrated Chinese Medicine (China) · CNLiaocheng People's Hospital · CNTangshan Gongren Hospital · CNTengzhou Central People's Hospital · CNTongji Hospital · CNShaoxing People's Hospital · CNUniversity of Antwerp · BE

Funding

Clinical Research Plan of Shanghai Hospital Development Center 16CR3011ANational Natural Science Foundation of China 81671198National Natural Science Foundation of China 81971699Shanghai Municipal Education Commission-Gaofeng Clinical Medicine 20152212
6 · The paper itself

Abstract

purposeSevere 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.

methodsThis 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.

resultsBetween 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.

conclusionRight median nerve electrical stimulation is a possible effective treatment for patients with acute traumatic coma, that will require validation in a confirmatory trial.

Indexed as

Brain Injuries, TraumaticComa, Post-Head InjuryComaElectric StimulationGlasgow Coma ScaleHumansMedian NerveComaElectrical stimulationRight median nerveTraumatic brain injury

Identifiers

PMID37178149
PMCPMC10182548
OpenAlexW4376613271

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.