| Background and Purpose: Stroke is currently the number one cause of death in China and the leading cause of disability.Ischemic stroke accounts for about 85% of total cerebrovascular events.Early and rapid recovery of cerebral blood flow in ischemic penumbra is the most important treatment strategy at present,including recanalization of an occluded vessel and enhancement of collateral flow.Recanalization therapies,including intravenous thrombolysis or endovascular thrombectomy,but both are limited by a certain time window and technical conditions.Improving collateral circulation has become a hot and difficult issue in current clinical research.Various methods have been designed to increase cerebral blood perfusion in penumbra by enhancing collateral circulation,thereby improving the neurological prognosis of patients,but all studies have not obtained a positive conclusion.In recent years,more and more studies have suggested that changing the head position of patients with ischemic stroke will improve the cerebral blood perfusion,but the effect on the neurological prognosis is still inconclusive.Our recent animal studies and preliminary clinical studies suggest that a head-down position can significantly increase cerebral blood perfusion,which in turn improves neurological function.Therefore,the purpose of this study was to evaluate the safety and efficacy of head-down treatment for patients with acute moderate severity atherosclerotic stroke.Methods: This multi-center clinical study was a prospective,randomized,open-label,blinded endpoint evaluation,enrolling patients with anterior circulation large arteryatherosclerotic stroke,moderate neurological deficits [(National Institute of Health Stroke Scale,NIHSS)score 6-16],and within 24 hours of onset.Patients who met the eligibility criteria were randomly assigned to the experimental group(head-down)and the control group.The experimental group was combined with head-down treatment on the basis of guideline treatment,that is,within 24 hours of enrollment,maintained a-20 degrees supine position if patients can tolerate.From the second day to discharge,3times a day head-down training,1-1.5 hours each time.The control group was given guideline-based treatment.The primary outcome was degree of disability at 90 days,as assessed with the use of the modified Rankin Scale,m RS(0-1)was defined as good prognosis and m RS(2-6)was defined as poor prognosis.Results: From December 2018 to July 2019,a total of 1680 patients with acute ischemic stroke were screened in 7 centers.Finally,38 patients who met the inclusion and exclusion criteria participated in this study.After signing the informed consent,19 patients were randomized to the experimental group and 19 patients were randomized to the control group.After randomization,4 patients in the experimental group were excluded,and 2 patients in the control group were excluded.Lastly 15 patients in the experimental group,17 patients in the control group were included in the analysis.There were no significant differences in demographic data(age,gender),past medical history,admission blood pressure,baseline NIHSS score,location and degree of vascular stenosis,type of antithrombotic therapy after admission,laboratory indexes(blood lipid,uric acid,homocysteine,cystatin C,neutrophil to lymphocyte ratio),and rehabilitation after discharge between the groups.There were no significant between-group difference in the primary outcome of the m RS(0-1)(p = 0.645)and secondary outcome of m RS(0-2)at 90 days(p = 0.070).There were no differences in the90-day m RS between groups: median 2 versus 3,p = 0.137.Within 48 hours of admission,1 patient in each group experienced neurological deterioration,and the difference was not statistically significant.There were no differences in the stroke recurrence events between groups: 1 case(6.7%)versus 2 cases(11.8%).In addition,1patient in the control group died of stroke within 90 days.There were no significantdifference between the two groups in the 12-day NIHSS and the admission NIHSS minus 12-day NIHSS.After 12 days,in the experimental group,the median time of maximum tolerability of the head-down was 40 minutes.There were no significant differences in adverse events,including stroke associated pneumonia between groups.No symptomatic intracranial hemorrhage occurred in either group.Conclusion: The preliminary results of this study show that head-down treatment for acute moderate severity atherosclerotic stroke within 24 hours of onset is safe and feasible.It has a tendency to improve the 90-day neurological prognosis of patients,the results are expected to be confirmed by subsequent trials.Clinical trial registration-URL: https://www.clinicaltrials.gov.Unique identifier:NCT03744533. |
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