Pilot study of electrical stimulation on median nerve in comatose severe brain injured patients: 3-month outcome

Primary objective: To determine if electrical stimulation (ES) benefits (waking time, 3-month outcomes) treated coma patients. Research design: Double blind randomized-controlled study. Methods and procedures: Ten coma patients; six treatment and four controls, using the 'Respond Select' by EMPI. Experimental interventions: Treatment group received radial nerve ES applied in 300 ms intermittent pulses at 40 Hz, 15-20 mÅ 8 hours a day up to 14 days of coma; control group received sham stimulation. Main outcomes and results: ES group emerged from coma mean 2 days earlier than controls, although this result was not statistically significant. At 3 months post-injury, there was no group difference in Glasgow Outcome Scale, although the ES group had improved function over controls as measured by the FIM/FAM (mean of 114 and 64.5, respectively, n.s.). Conclusions: These data show an interesting trend, although statistical power was limited in this small pilot study, suggesting the need for a larger trial.