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Randomized Controlled Trial
. 2023 Jun;49(6):633-644.
doi: 10.1007/s00134-023-07072-1. Epub 2023 May 13.

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

Xiang Wu #  1 , Li Xie #  2 , Jin Lei #  3 , Jiemin Yao  4 , Jiarong Li  5 , Lixin Ruan  6 , Jun Hong  7 , Guodong Zheng  8 , Yangyu Cheng  9 , Liansheng Long  10 , Jiancun Wang  11 , Chuanping Huang  12 , Qiuyou Xie  13 , Xuelei Zhang  14 , Jianghong He  15 , Xuebin Yu  16 , Shouhua Lv  17 , Zhaosheng Sun  18 , Dai Liu  19 , Xin Li  20 , Jianxin Zhu  21 , Xiaoliang Yang  22 , Dongdong Wang  23 , Yijun Bao  24 , Andrew I R Maas  25   26 , David Menon  27 , Yajun Xue #  1 , Jiyao Jiang  28   29 , Junfeng Feng #  28   29 , Guoyi Gao #  30   31   32 ; ACES Participants
Collaborators, Affiliations
Randomized Controlled Trial

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

Xiang Wu et al. Intensive Care Med. 2023 Jun.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02645578.

Keywords: Coma; Electrical stimulation; Right median nerve; Traumatic brain injury.

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Conflict of interest statement

All authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Trial profile. GCS Glasgow Coma Scale, GMS Glasgow Coma Scale Motor Part, RMNS right median nerve electrical stimulation, ITT intention to treat
Fig. 2
Fig. 2
Percentage of patients who regained consciousness in both groups at 6 months after injury
Fig. 3
Fig. 3
Cumulative incidence for consciousness and death in both groups
Fig. 4
Fig. 4
Subgroup analysis of consciousness rate. Shown are the results of subgroup analyses of the RMNS effect on consciousness rate. Ratios of consciousness in the RMNS group, as compared with the control group, are shown along with 95% confidence intervals. The results were adjusted for baseline variables including age, gender, GCS and CT findings
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