Right median nerve electrical stimulation for acute traumatic coma (the Asia Coma Electrical Stimulation trial): study protocol for a randomised controlled trial.

BACKGROUND: Traumatic brain injury (TBI) has become the most common cause of death and disability in persons between 15 and 30 years of age, and about 10-15% of patients affected by TBI will end up in a coma. Coma caused by TBI presents a significant challenge to neuroscientists. Right median nerve electrical stimulation has been reported as a simple, inexpensive, non-invasive technique to speed recovery and improve outcomes for traumatic comatose patients. METHODS/DESIGN: This multicentre, prospective, randomised (1:1) controlled trial aims to demonstrate the efficacy and safety of electrical right median nerve stimulation (RMNS) in both accelerating emergence from coma and promoting long-term outcomes. This trial aims to enrol 380 TBI comatose patients to partake in either an electrical stimulation group or a non-stimulation group. Patients assigned to the stimulation group will receive RMNS in addition to standard treatment at an amplitude of 15-20 mA with a pulse width of 300 µs at 40 Hz ON for 20 s and OFF for 40 s. The electrical treatment will last for 8 h per day for 2 weeks. The primary endpoint will be the percentage of patients regaining consciousness 6 months after injury. The secondary endpoints will be Extended Glasgow Outcome Scale, Coma Recovery Scale-Revised and Disability Rating Scale scores at 28 days, 3 months and 6 months after injury; Glasgow Coma Scale, Glasgow Coma Scale Motor Part and Full Outline of Unresponsiveness scale scores on day 1 and day 7 after enrolment and 28 days, 3 months and 6 months after injury; duration of unconsciousness and mechanical ventilation; length of intensive care unit and hospital stays; and incidence of adverse events. DISCUSSION: Right median nerve electrical stimulation has been used as a safe, inexpensive, non-invasive therapy for neuroresuscitation of coma patients for more than two decades, yet no trial has robustly proven the efficacy and safety of this treatment. The Asia Coma Electrical Stimulation (ACES) trial has the following novel features compared with other major RMNS trials: (1) the ACES trial is an Asian multicentre randomised controlled trial; (2) RMNS therapy starts at an early stage 7-14 days after the injury; and (3) various assessment scales are used to evaluate the condition of patients. We hope the ACES trial will lead to optimal use of right median nerve electrical treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02645578 . Registered on 23 December 2015.

Right Median Nerve Electrical Stimulation for Acute Traumatic Coma Patients.

The right median nerve as a peripheral portal to the central nervous system can be electrically stimulated to help coma arousal after traumatic brain injury (TBI). The present study set out to examine the efficacy and safety of right median nerve electrical stimulation (RMNS) in a cohort of 437 comatose patients after severe TBI from August 2005 to December 2011. The patients were enrolled 2 weeks after their injury and assigned to the RMNS group (n=221) receiving electrical stimulation for 2 weeks or the control group (n = 216) treated by standard management according to the date of birth in the month. The baseline data were similar. After the 2-week treatment, the RMNS-treated patients demonstrated a more rapid increase of the mean Glasgow Coma Score, although statistical significance was not reached (8.43 ± 4.98 vs. 7.47 ± 5.37, p = 0.0532). The follow-up data at 6-month post-injury showed a significantly higher proportion of patients who regained consciousness (59.8% vs. 46.2%, p = 0.0073). There was a lower proportion of vegetative persons in the RMNS group than in the control group (17.6% vs. 22.0%, p = 0.0012). For persons regaining consciousness, the functional independence measurement (FIM) score was higher among the RMNS group patients (91.45 ± 8.65 vs. 76.23 ± 11.02, p < 0.001). There were no unique complications associated with the RMNS treatment. The current study, although with some limitations, showed that RMNS may serve as an easy, effective, and noninvasive technique to promote the recovery of traumatic coma in the early phase.

[Recovery of consciousness by electrical dorsal column stimulation in brain injury patients].

Treatment with electrical dorsal column stimulation was performed in 7 cases of diffuse axonal injury, 2 cases of brain contusion and 1 case of hypoxic diffuse brain damage. After inadequate response to various treatment modalities, each patient was implanted with a spinal cord stimulation system. The effectiveness was assessed using a standard scoring system which consisted of state scale and reaction scale (the society for treatment of coma). Both state scale and reaction scale were considered to improve in 4 patients after dorsal column stimulation. In 5 patients, the effectiveness of dorsal column stimulation could not be distinguished from natural improvement. One patient of hypoxic brain damage showed slight deterioration after the dorsal column stimulation. Among the state scale, significant improvement was found in spontaneous movement of the oral cavity and pharynx, spontaneous changes of expression muscles, concern about circumstances, voluntary purposeful movement, and coherent verbalization 2 weeks after the operation. As dorsal column stimulation can cause consciousness recovery from the semicomatose state, it should be considered as the treatment choice for the consciousness disturbance.

Acute management of acquired brain injury Part III: an evidence-based review of interventions used to promote arousal from coma.

PRIMARY OBJECTIVE: To review the literature regarding techniques used to promote arousal from coma following an acquired brain injury. MAIN OUTCOMES: A literature search of multiple databases (CINAHL, EMBASE, MEDLINE and PsycINFO) and hand searched articles covering the years 1980-2008 was performed. Peer reviewed articles were assessed for methodological quality using the PEDro scoring system for randomized controlled trials and the Downs and Black tool for RCTs and non-randomized trials. Levels of evidence were assigned and recommendations were made. RESULTS: Research into coma arousal has generally focused on the stimulation of neural pathways responsible for arousal. These pathways have been targeted using pharmacological and non-pharmacological techniques. This review reports the evidence surrounding agents targeting dopamine pathways (amantadine, bromocriptine and levodopa), sensory stimulation, music therapy and median nerve electrical stimulation. Each of these interventions has shown some degree of benefit in improving consciousness, but further research is necessary. CONCLUSIONS: Despite numerous studies, strong evidence was only found for one intervention (Amantadine use in children) and this was based on a single study. However, each of the interventions showed promise in some aspect of arousal and warrant further study. More methodologically rigorous study is needed before any definitive conclusions can be drawn.

Electrical treatment of coma via the median nerve.

The median nerve is a portal to interact with the injured comatose brain. Peripheral nerve electrical stimulation has a central nervous system effect. Two to three weeks of right median nerve stimulation (RMNS) can hasten awakening from deep coma by increasing the dopamine levels. Three cases of electrically treated GCS-4 teenagers with acute diffuse brain injuries from motor vehicle crashes are presented by video. Pilot studies of RMNS for acute post-traumatic coma states have been done over the last ten years at East Carolina University and the University of Virginia. The neurophysiological effects of RMNS have been well documented at several neurosurgical centers in Japan using neuroimaging and spinal fluid assays. RMNS is a safe, inexpensive, non-invasive therapy for neuro-resuscitation of coma patients. When employed early in the coma, the time in the ICU may be shortened and the quality of the final outcome may be enhanced.