ACES
Trial question
What is the role of right median nerve electrical stimulation in patients with acute traumatic coma?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 329
329 patients (96 female, 233 male)
Inclusion criteria: patients with acute coma at 7-14 days after traumatic brain injury
Key exclusion criteria: unstable vital signs; history of epilepsy; severe cardiac arrhythmia; pacemaker implantation
Interventions
N=167 right median nerve electrical stimulation (right median nerve stimulation treatment continued for 8 hours/day for 2 weeks plus standard management)
N=162 non-stimulation (standard management without any electrical stimulation)
Primary outcome
Rate of proportion of patients regaining consciousness 6 months post-injury
72.46
56.79
72.5 %
54.3 %
36.2 %
18.1 %
0.0 %
Right median nerve electrical stimulation
Non-stimulation
Significant increase ▲
NNH = 6
Significant increase in the rate of proportion of patients regaining consciousness 6 months post-injury (72.46% vs. 56.79%; AD 15.66%, 95% CI 5.46 to 25.87)
Secondary outcomes
Significant increase in Glasgow Outcome Scale Extended score at 3 months (5 vs. 4 ; AD 1 , 95% CI 0.37 to 1.63)
Significant increase in favorable outcome at 3 months (63.47% vs. 40.74%; AD 22.73%, 95% CI 11.37 to 34.09)
Significant increase in Full Outline of Unresponsiveness scale at 28 days (15 vs. 13 ; AD 2 , 95% CI 0.73 to 3.27)
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with acute coma at 7-14 days after traumatic brain injury, right median nerve electrical stimulation was superior to non-stimulation with respect to the rate of proportion of patients regaining consciousness 6 months post-injury.
Reference
Xiang Wu, Li Xie, Jin Lei et al. Acute traumatic coma awakening by right median nerve electrical stimulation: a randomised controlled trial. Intensive Care Med. 2023 Jun;49(6):633-644.
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