Data_Sheet_1_Randomized trial of transcutaneous auricular vagus nerve stimulation on patients with disorders of consciousness: A study protocol.doc

BackgroundTranscutaneous auricular vagus nerve stimulation (taVNS) has recently been explored for the treatment of Disorders of consciousness (DoC) caused by traumatic brain injury. The evidence of taVNS during the consciousness recovery has been recently reported. However, the mechanism of taVNS in the recovery of consciousness is not clear. This study attempts to investigate the effectiveness of taVNS in DoC by means of Coma Recovery Scale-Revised (CRS-R), Magnetic resonance imaging (MRI), Electrophysiology (EEG), and Single-molecular array (Simoa).Methods/designNighty patients with DoC acquired brain injury are randomized into one of three groups receiving sham taVNS or active taVNS (just left and left or right), respectively. Each of the three groups will experience a 40 days cycle (every 10 days for a small period, baseline 2 weeks, intervention 2 weeks, 40 min per day, 5 days per week, then no intervention for 2 weeks, intervention 2 weeks, 40 min per day, and 5 days per week). Primary outcomes (CRS-R) will be recorded five times during every period. Secondary outcomes will be recorded at the first and at the last period [MRI, EEG, Phosphorylated tau (P-tau), and Neurofilament light chain (NFL)]. We will take notes the adverse events and untoward effects during all cycles.DiscussionTranscutaneous auricular vagus nerve stimulation as a painless, non-invasive, easily applied, and effective therapy was applied for treatment of patients with depression and epilepsy several decades ago. Recent progress showed that taVNS has behavioral effects in the consciousness recovery. However, there is no clinical evidence to support the effects of taVNS on brain activity. Therefore, we will design a randomized controlled trial to evaluate the effectiveness and safety of taVNS therapy for DoC, and explore neural anatomy correlated to taVNS during the consciousness recovery. Finally, this protocol also tests some biomarkers along with the recovery of consciousness.Clinical Trial RegistrationChinese Clinical Trial Registry, ChiCTR2100045161. Registered on 9 April 2021.</p

Chinese translation of the Coma Recovery Scale—Revised

<p><i>Background</i>: Misdiagnosis rate is high in patients with disorders of consciousness, potentially leading to an inappropriate clinical management of these patients. Sensitive standardised rating scales offer some protections from these diagnostic errors. In this context, the use of the Coma Recovery Scale-Revised (CRS-R) has strongly been recommended by the American Congress of Rehabilitation Medicine. <i>Objective</i>: Here, we present the work that has been performed to translate this important diagnostic tool in Chinese. <i>Methods</i>: The scale has been translated from its original English version to Chinese by a team of native Chinese speakers in agreement with an expert highly trained in the use of the original version of the CRS-R and, then, back-translated to English by four independent translators blinded to the original version. The resulting translation has been sent to the original author for final approval. <i>Results and conclusion</i>: The Chinese version of the CRS-R is now available for use in clinical practise. Further investigations will nevertheless be needed in order to show that its psychometric properties are identical to the original English version.</p

Additional file 1: of Personalized objects can optimize the diagnosis of EMCS in the assessment of functional object use in the CRS-R: a double blind, randomized clinical trial

CONSORT 2010 checklist of information to include when reporting a randomised trial. (DOC 217 kb

Table_1_Chinese translation and validation of the Near-Death Experience Content scale.DOCX

IntroductionIn recent years, a growing number of near-death experience (NDE) testimonies have been collected worldwide due to an increasing interest in research on this phenomenon. China has many patients who survive life-threatening situations, leaving over much data on NDEs to be collected for research. In the historical context of Eastern civilization, many mentally controlled practices in China can also lead to “NDEs-like” (e.g., meditation). This study aimed (1) to translate and validate the recently developed Near-Death Experience Content (NDE-C) scale into Chinese and (2) to quantify and identify NDEs and NDEs-like in China with this new Chinese version of the NDE-C scale.MethodsHere, we presented the work that had been performed to translate the NDE-C scale into Chinese and validated this version on 79 NDE testimonies.ResultsBrislin’s back-translation model was performed to translate a Chinese version of the NDE-C scale and internal consistency (the Cronbach’s α value for the total group = 0.846) as well as the confirmatory factor analysis was conducted.DiscussionCurrently, the Chinese version of the NDE-C scale is ready for use in research practice in the context of Eastern culture, to screen people who have experienced an NDEs(-like) and to quantify their subjective experience, promoting further NDEs-related research in China.</p