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
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 ▲
NNT = 6
Significant increase in the 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 points vs. 4 points; AD 1 points, 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 points vs. 13 points; AD 2 points, 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 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.
Open reference URL