Awakening Effect of Multisensory Stimulation System on Comatose Patients with Neurocritical Illness: study protocol for a randomized clinical trial

Background: Severe neurological coma is a key issue in the field of neurological rehabilitation treatment. This study aims to explore the effects of a personalized image-based multisensory stimulation system on brain function and the consciousness state of coma patients. Methods: This study is a prospective, randomized, controlled, double-blind trial. 54 eligible patients will be included, and they will be randomly divided into two groups. Group A receive personalized visual and auditory stimulation interventions based on a multisensory stimulation system in addition to conventional treatment. And group B is treated with black grid picture stimulation intervention on the basis of conventional treatment. The duration of stimulation in both groups is 20 minutes per day, five times a week, for a total of 20 times. Oxyhemoglobin and deoxyhemoglobin and total hemoglobin concentrations obtained by functional near-infrared spectroscopy were measured at week 0, 2 weeks, and 4 weeks after treatment. And electroencephalogram (EEG) capture of derived EEG activity associated with the prefrontal-central and frontoparietal motor/premotor networks as well as other sources and assessment by the CRS-R scale. Discussion: The multi-sensory stimulation system based on a personalized scene screen may improve the brain function and consciousness state of patients with severe neurological coma and enhance the effect of wake-up promotion. Trial registration: The study protocol has been registered in the Chinese Clinical Trial Registry with the registration number of ChiCTR2300078664. The study protocol alsohas been approved by the Ethics Committee of Shanghai Hebin Rehabilitation Hospital, andthe approval number is HBRH-MEC2023001.