Asia Pacific Journal of Clinical Trials: Nervous System Diseases最新文献

{"title":"Transdiagnostic cognitive behavioral therapy based on unified protocol: new approach to emotional disorders","authors":"S. Khakpoor, O. Saed","doi":"10.4103/2542-3932.245225","DOIUrl":"https://doi.org/10.4103/2542-3932.245225","url":null,"abstract":"One of the new and evidence-based interventions recently developed to address psychological disorders is the unified protocol for transdiagnostic treatment of emotional disorders. The protocol was designed using transdiagnostic theories emphasizing the commonalities between disorders. The present work aimed to provide an overview of the unified protocol by reviewing the theories and studies carried out in this area.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72956016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of vestibular stimulation treatment in the depressive phase of bipolar disorder: study protocol for a randomized, double-blind, controlled trial","authors":"A. Soza, S. Barroilhet, P. Vöhringer","doi":"10.4103/2542-3932.238435","DOIUrl":"https://doi.org/10.4103/2542-3932.238435","url":null,"abstract":"Background and objectives: Bipolar disorder (BD) is a neuropsychiatric disorder characterized by the oscillation of mood states between hypoactive/pessimistic (depressive phase) and hyperactive/optimistic states (manic/hypomanic phase). Previous studies evidenced that a particular technique of neuro-vestibular stimulation is an effective treatment for major depression. This study will investigate the efficacy of the said vestibular stimulation technique in the depressive phase of BD, and will compare it with sham vestibular stimulation. Design: A double-blind, randomized controlled study. Methods: One hundred and twenty patients with bipolar type I or II, currently undergoing a depressive phase, will be randomized into the experimental group (n = 60) or control group (n = 60), receiving three sessions of real/sham vestibular stimulation. Outcome measures: The primary outcome is the change in Montgomery Asberg Depression Rating Scale scores from baseline to post 4 and 12 weeks. The secondary outcome is the vestibular activity assessed at baseline, post 4 and 2 weeks. Discussion: Currently, no treatment has proved efficacy for bipolar depression. Studies have demonstrated that lateralized neuro-vestibular stimulation is an effective treatment for mayor depression but has not been studied in the depressive phase of bipolar disorder. This investigation will give the first evidence supporting or denying the use of vestibular stimulation treatment in BD depression. Ethics and dissemination: This study protocol was approved by the Ethics Committee of SSMO (Servicio de Salud Metropolitano Oriente) in Santiago, Chile (approval No. 08032016) on March 8, 2016. The results of the study will be published in scientific journals and other media. Trial registration: ClinicalTrials.gov Identifier: NCT02778256.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73005190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mindfulness training programme for undergraduate and graduate students with depression, anxiety and stress symptoms: Study protocol for a randomized controlled trial","authors":"A. Assumpção, C. Neufeld, M. Teodoro","doi":"10.4103/2542-3932.238434","DOIUrl":"https://doi.org/10.4103/2542-3932.238434","url":null,"abstract":"Background and objectives: High prevalence rates of depression, anxiety and stress symptoms in undergraduate and graduate students have been pointed out as a growing concern in the literature. The high indexes of these psychopathological symptoms are considered a serious health problem, since they imply losses in the institutional, social and family spheres. Research on mindfulness interventions has demonstrated positive results in treating these symptoms. The study aims to evaluate the efficacy of mindfulness training programme in the treatment of depression, anxiety and stress symptoms in undergraduate and graduate students. Design: This is a randomized parallel-design controlled trial. Methods: Undergraduate and graduate students from the Federal University of Minas Gerais with depressive, anxiety and stress symptoms will be randomized into control and training group (n = 24/group). Mindfulness training will take place in a weekly meeting within 6 weeks and will be in a group format constituted by 8-12 participants. Each meeting will take 90 minutes. The control group will also receive the intervention after 6 weeks in the wait list condition. Outcome measures: The primary outcomes are Beck Depression Inventory-II, Beck Anxiety Inventory, and Perceived Stress Scale scores. The secondary outcomes are Rosenberg Self-Esteem Scale, and 12-item Short-Form Health Survey scores. Discussion: This trial will evaluate the efficacy of mindfulness training programme for undergraduate and graduate students with depressive, anxious and stress symptoms. This will help to improve mental health and the quality of life, as well as reducing psychological and social burdens for this population. Ethics and dissemination: The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil on April 20th, 2017, approval number 2.025.573. The committee will audit the progression of the research. The investigation results will be disseminated on peer review scientific journals. Trial registration: This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21st, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86831012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of moxibustion on brain functional connectivity and effective brain networks in patients with amnestic mild cognitive impairment: study protocol for a randomized controlled trial and preliminary results","authors":"Xinyan Jia, Xu Yuan, Xiaomei Zhou, R. Jiao, H. Xie, Dan Wang, Liang Yin, Ting-ting Tan, Qi-Qi Liu, Shang-Jie Chen","doi":"10.4103/2542-3932.238437","DOIUrl":"https://doi.org/10.4103/2542-3932.238437","url":null,"abstract":"Background and objectives: Mild cognitive impairment (MCI) is an intermediate state between normal aging and dementia, and can be divided into amnestic and non-amnestic types. Patients with amnestic MCI present with memory impairments that are often considered as the early manifestation of Alzheimer’s disease. Patients with amnestic MCI are more likely to progress to Alzheimer’s disease than patients with non-amnestic MCI. The U.S. Food and Drug Administration has not yet approved any drug that can treat amnestic MCI. Moxibustion is a common noninvasive traditional oriental intervention, which uses mainly the heat generated by burning herbal preparations containing moxa and mugwort (Artemisia vulgaris) to simulate acupoints for alleviating the symptoms. To date, many clinical studies have investigated the clinical use of moxibustion to improve memory impairments of Alzheimer’s disease, but these have failed to make a distinction between amnestic and non-amnestic MCI. Therefore, this trial has been designed to assess the effectiveness of moxibustion on amnestic MCI using the Montreal Cognitive Assessment Scale. We will also assess the safety of moxibustion in healthy controls, and analyze the variation of brain functional connectivity and effective brain networks in patients with amnestic MCI undergoing moxibustion using function magnetic resonance imaging. Design: This is a prospective, single-center, randomized controlled clinical trial. Methods: This study will enroll 64 patients with amnestic MCI and 48 healthy controls at Baoan People’s Hospital, Shenzhen, China. The first 64 recruited patients with amnestic MCI will be randomly divided into moxibustion, placebo moxibustion, drug, and control groups (n = 16 per group). In the moxibustion group, patients will be given moxa-wool moxibustion for 12 consecutive weeks. The placebo moxibustion group will receive placebo moxibustion on the same acupoints. Patients in the drug group will be given oral administration of donepezil hydrochloride tablets, 5 mg daily, for 12 consecutive weeks. The control group will receive no intervention. Forty-eight healthy controls will also be randomly assigned into moxibustion, placebo moxibustion, and control groups (n = 16 per group). Interventions will be the same as those received by the patients with amnestic MCI. Evaluators will be blind to group allocation. Outcome measures and preliminary results: The primary outcome measure will be the improvement in cognitive function 12 months after treatment. Secondary outcome measures will be the scores on the Montreal Cognitive Assessment Scale, Clinical Dementia Rating Scale, Mini-Mental State Examination Scale, and Activity of Daily Living Scale before treatment, after 12 weeks of treatment, and 6 months after the end of treatment, as well as brain function analysis before treatment and after 12 weeks of treatment and adverse events during treatment and follow-up. A correlation analysis between cognitive function sco","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78095462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep-brain magnetic stimulation as add-on treatment to lithium carbonate in the treatment of bipolar depression: study protocol for a randomized, double-blind, sham-controlled trial","authors":"Le Xiao, G. Wang, Lei Feng","doi":"10.4103/2542-3932.238436","DOIUrl":"https://doi.org/10.4103/2542-3932.238436","url":null,"abstract":"Background and objectives: Bipolar disorder is a highly prevalent mental disorder. In clinical practice, mood stabilizers such as lithium carbonate are the conventional treatment for bipolar disorder. However, these drugs have slow onset of action and are not sufficiently effective in the acute phase. Deep-brain magnetic stimulation was hypothesized to have significant therapeutic effects in patients with major depressive disorder by entrainment of neural oscillations. In previous clinical trials, deep-brain magnetic stimulation showed good outcomes in the treatment of unipolar depression. However, randomized controlled trials that verify these results are lacking. Therefore, the current proposal intends to address this issue. Design: A single-center, randomized, double-blind, sham-controlled trial. Methods: Sixty patients aged 18–60 years who have been diagnosed with bipolar disorder at Beijing Anding Hospital, Capital Medical University of China, will be included and randomly divided into experimental and control groups (n = 30 per group). Patients in the experimental group will be treated with deep-brain magnetic stimulation plus lithium carbonate for 2 weeks followed by subsequent treatment with only lithium carbonate for 4 weeks. Patients in the control group will be treated with the same protocol, except they will receive sham stimulation. Outcome measures: The primary outcome measure is the change in score on the 17-Item Hamilton Rating Scale for Depression at weeks 2 and 6. The secondary outcome measures include response rate, complete remission rate (clinical cure rate), and changes in scores on the Hamilton Anxiety Rating Scale, 16-Item Quick Inventory of Depressive Symptomatology Self-Report, Generalized Anxiety Disorder-7, 9-Item Patient Health Questionnaire, Young Mania Rating Scale, Clinical Global Impression-Bipolar Disorder, and Montreal Cognitive Assessment at visit points relative to baseline scores. The safety evaluation indicators are the incidence of adverse events and the rate of manic switch. Discussion: The trial will verify the effectiveness of deep-brain magnetic stimulation with lithium carbonate in the treatment of bipolar disorder, providing evidence as to whether this combined therapy has the potential to be new alternative treatment for bipolar disorder. Ethics and dissemination: The trial was approved by the Ethics Committee of Beijing Anding Hospital, Capital Medical University in China (approval No. 201777FS-2) on October 27, 2017. Design of the trial was completed on June 28, 2017, and the trial registration was completed at the Chinese Clinical Trial Registry on November 10, 2017. Recruitment was initiated in January 2018 and it is expected to be completed in December 2018. Follow-up visit will end in June, 2019. Data analysis will be completed in December 2019. The results of the study will be disseminated through presentations at scientific meetings and/or in peer-reviewed publications. Anonymized trial data ","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83628091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transvenous embolization for intracranial arteriovenous malformations: study protocol for a prospective, single-center cohort trial","authors":"Yanyan He, Tianxiao Li, W. Bai, Yingkun He, Bin Xu, Xiaoyu Kang, Jiang-yu Xue","doi":"10.4103/2542-3932.232078","DOIUrl":"https://doi.org/10.4103/2542-3932.232078","url":null,"abstract":"Background and objectives: In 2010, Nguyen et al. reported a novel method for the treatment of intracranial arteriovenous malformations by transvenous embolization combined with conventional treatment. At present, although the outcome of this approach is generally good, most studies are case reports, and there is a lack of prospective cohort study for assessing the effectiveness of this method. Therefore, in this clinical trial protocol, we will assess the efficacy of transvenous embolization of draining venous unit, with the aim of helping to optimize treatment strategies for patients with intracranial arteriovenous malformations. Design: This is a prospective, single-center cohort study. Methods: We will recruit 190 patients with intracranial arteriovenous malformations from the Department of Intracranial Arteriovenous Malformation, Henan Provincial People's Hospital, China. The patients will be assigned to two groups. Participants in the control group (n = 95) will undergo conventional treatment, such as surgery, stereotactic radiosurgery and transarterial embolization. Participants in the trial group (n = 95) will receive transvenous embolization combined with conventional treatment. Outcome measures: The primary outcome measures are stroke or death within 30 days of surgery, and efficacy of treatment at 6 months postoperatively. The secondary outcome measures are the efficacy of treatment at 30 days and 24 months postoperatively, National Institutes of Health Stroke Scale scores, modified Rankin Scale scores at 1, 7 and 30 days and 3, 6, 12, 24 and 36 months postoperatively, and adverse reactions during treatment and follow-up. Discussion: Our study will provide clinical evidence for the rational use of transvenous embolization for intracranial arteriovenous malformations. Ethics and dissemination: This trial has been approved by the Medical Ethics Committee of Henan Provincial People's Hospital of China [approval number: 2017 (41)]. This trial was designed in 1 August 2017. Ethics approval was completed in 19 October 2017. This trial was registered in 11 December 2017. The recruitment of participants began in January 2018. The recruitment will be finished in January 2019. Follow-up will be completed in January 2022. Data analysis will be finished in January 2023. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-17013851). Protocol version (1.0).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81773017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multimode computed tomography evaluation of the efficacy and safety of an extended thrombolysis time window (3–9 hours) for acute ischemic stroke: study protocol for a retrospective clinical trial based on medical records","authors":"Xue-yuan Li, Wei Sun, Yingxia Yang, Xin Zhang, Dong-Mei Li, Hong-Zhi Wang, Xin-Ning Sui, H. Chang, Xiuying Teng, Teng Hu, Jing-bo Zhang","doi":"10.4103/2542-3932.232076","DOIUrl":"https://doi.org/10.4103/2542-3932.232076","url":null,"abstract":"Background and objectives: Intravenous thrombolysis with recombinant tissue plasminogen activator within 3 hours of acute ischemic stroke onset can reduce the risk of death and severe disability. There are differences in collateral circulation, the compensatory ability of cerebral blood vessels, and brain metabolism between each patient, leading to differences in the thrombolysis time window. Thrombolysis is considered effective in patients 3 hours after onset; however, it remains controversial whether this time window should be extended. Therefore, we will employ a retrospective case analysis study using multimode computed tomography (CT) to observe the extended time window (3–9 hours after stroke onset) and to summarize its efficacy and safety in the treatment of acute ischemic stroke. Design: This is a retrospective, single-center, case-analysis clinical trial. Methods: We will retrospectively collect data from 450 patients with acute ischemic stroke who have undergone thrombolytic therapy in the Third People's Hospital of Dalian, China, from June 2008 to December 2017. The time window will be set to 3–9 hours after stroke onset. We will evaluate the effect of this extended thrombolysis time window using multimode CT. Outcome measures: The primary outcome measure is the National Institutes of Health Stroke Scale (NIHSS) score 7 days after treatment or at discharge, to evaluate the effect of thrombolysis. The secondary outcome measures are as follows: the occurrence of hemorrhagic events 24–36 hours and 7 days after treatment; NIHSS score at 2 and 24–36 hours, and at 3 and 12 months after treatment; modified Rankin scale score at 7 days after treatment or discharge, and at 3 and 12 months after treatment; vascular stenosis and infarct size 24–36 hours and 7 days after treatment; incidence of adverse reactions and deaths at 3 months after treatment; incidence of symptomatic intracranial hemorrhagic transformation during hospitalization; vital signs and laboratory measurements (blood indexes, blood glucose, blood lipids, liver and kidney functions, myocardial enzymes, blood electrolytes, and coagulation function); and electrocardiography results. Discussion: Under the guidance of multimode CT, we will extend the thrombolysis time window to 9 hours after the onset of the disease, and summarize the efficacy and adverse reactions of an extended time window for intravenous thrombolysis after acute ischemic stroke. This trial will provide objective data for the optimization of clinical diagnoses and treatment pathways for patients. Ethics and dissemination: This trial has been approved by the Medical Ethics Committee of The Third People's Hospital of Dalian, China on December 5, 2017. The study protocol will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. This trial was designed in October 2017. Data collection has begun in January 2018 and will finish in October 2018. Outcome measures will be ","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90550172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuroelectrophysiological characteristics of peripheral neuropathy in primary Sjögren's syndrome: study protocol for a prospective case series and pre-preliminary results","authors":"Dan Wang, Zhong-ming Li, Mingyi Zhao, Ruo‐hong Xue, Hong Xu, Lian-mei Zhong","doi":"10.4103/2542-3932.232079","DOIUrl":"https://doi.org/10.4103/2542-3932.232079","url":null,"abstract":"Background and objectives: Sjögren's syndrome (SS) is a chronic progressive autoimmune disease. The incidence of peripheral nervous system damage in patients with primary SS (pSS) is 10–30%. Previous studies have shown that there are multiple electrophysiological manifestations in pSS patients presenting with peripheral neuropathy. However, there is no consensus on its neuroelectrophysiological manifestations. Peripheral neuropathy associated with pSS is easily confused with peripheral neuropathy of other etiologies. We hope to observe the neuroelectrophysiological manifestations of peripheral neuropathy associated with pSS to assist in the diagnosis of the disease. Design: A prospective case series. Methods: A total of 100 pSS patients with peripheral neuropathy receiving treatment in the Department of Neurology, First Affiliated Hospital of Kunming Medical University, China will be included in this study. Fifty-two patients presenting with peripheral neuropathy associated with pSS have been included in a preliminary investigation. Outcome measures and preliminary results: The primary outcome measure is the incidence of abnormal motor nerve conduction velocity in these patients. The secondary outcome measures are the incidences of abnormalities in terminal motor latencies, compound muscle action potential amplitudes, sensory nerve conduction velocities, sensory nerve action potential amplitudes, F waves, and sympathetic skin responses. The results of 52 patients included in the preliminary study showed that the incidences of each electrophysiological index was similar between the upper and lower extremities. Abnormal motor nerve conduction velocity occurred more frequently than abnormal compound muscle action potential amplitude. Abnormal sensory nerve conduction velocity was observed significantly more often than abnormal sensory nerve action potential amplitude. Abnormal motor nerve conduction velocity had a similar incidence to abnormal sensory nerve conduction velocity. Abnormal compound muscle action potential amplitude had a similar incidence to abnormal sensory nerve action potential amplitude. Abnormal F waves were observed significantly less frequently than abnormal motor nerve conduction study. Abnormal sympathetic skin response was seen with a similar incidence to abnormal motor nerve conduction study. Discussion: The results of this study, as indicated by the preliminary investigation, will reveal the neuroelectrophysiological abnormalities in peripheral neuropathy associated with pSS, which will aid diagnosis of the disease. Ethics and dissemination: This study was approved by Medical Ethics Committee of Kunming Medical University of China on October 14th, 2005 (approval No. 20051014). The study protocol was designed in September 2016 and registered in April 2018. The study protocol received ethics approval from Medical Ethics Committee of Kunming Medical University of China on October 14th, 2016 (approval No. 2016101411). Patient r","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85327765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical treatment outcomes of acute ischemic stroke: protocol for a registry ambispective cohort study","authors":"Dong-Sun Han, Shuang Liu, Xin Qiao, Yan Gao, Jia Liu, Juan Feng","doi":"10.4103/2542-3932.232077","DOIUrl":"https://doi.org/10.4103/2542-3932.232077","url":null,"abstract":"Background and objectives: Many types of neuroprotective agents and traditional Chinese medicines are commonly used for the clinical treatment of ischemic stroke in China. However, there is no high-quality randomized controlled trial assessing efficacy and safety, and these medicines have not been recommended in the guidelines. Therefore, in this study, we will analyze the treatment outcomes of acute ischemic stroke in the clinic. Design: This is a registry, single-center, ambispective cohort study. Methods: The study will be conducted at the Shengjing Hospital of China Medical University, China. Data for 600 cases of acute ischemic stroke from October 2016 to November 2017 were retrospectively collected for trend analysis in January 2018. Furthermore, data for 1400 cases of acute ischemic stroke have been prospectively collected since February 2018. Stroke patients will be visited five times: on admission (baseline assessment, visit 1), during medication and treatment in the hospital (visit 2), at discharge (visit 3), 90 ± 14 days after treatment (outpatient clinic or telephone follow-up, visit 4), and 360 ± 28 days after treatment (telephone follow-up, visit 5). Outcome measures: Outcome measures will include vital signs, electrocardiogram, laboratory findings and imaging findings, Glasgow Coma Scale, Essen Stroke Risk Score, National Institutes of Health Stroke Scale, modified Rankin Scale, and adverse events. National Institutes of Health Stroke Scale score at discharge (visit 3) will be the primary outcome measure; the remainder will be secondary outcome measures. Discussion: This study of the clinical treatment and outcomes of acute ischemic stroke should help in optimizing clinical diagnosis and treatment. Ethics and dissemination: This trial was designed in October 2017. This trial has been approved by the Ethics Committee of Shengjing Hospital of China Medical University of China in December 2017 (approval number: 2017PS40K). This trial was registered in December 2017. Subjects with acute ischemic stroke from October 2016 to November 2017 were retrospectively recruited for trend analysis in January 2018. Other subjects began to be prospectively recruited from February 2018, and prospective collection will be finished within 36 months. Each subject will be followed up for 360 days. The follow-up will be completed in November 2021. Data analysis will be finished in November 2022. The results of the trial will be disseminated in a peer-reviewed journal. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-17013773). Protocol version (1.0).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87525860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Umbilical cord mesenchymal stem cell and neural stem cell therapy for cerebral palsy: study protocol for a randomized, parallel-controlled trial","authors":"Jing Liu, Jie Han, Lu Ma, Z. Lian, Ying Li, Xiao-Yan Li, Wen-juan Wei, Chao Han, Jingyuan Zhao, Xin Guan","doi":"10.4103/2542-3932.226187","DOIUrl":"https://doi.org/10.4103/2542-3932.226187","url":null,"abstract":"Background and objectives: Cerebral palsy is the most common cause of dyskinesia in children and is not curable by generalized rehabilitation, pharmacotherapy, Chinese medicine, exercise therapy, or surgery. To date, several case reports have demonstrated that umbilical cord mesenchymal stem cells (UCMSCs)/neural stem cells (NSCs) have a therapeutic role in children with cerebral palsy; however, there has been no large-sample clinical trial to verify this. Therefore, there is a need to evaluate the safety and effectiveness of UCMSCs/NSCs for the treatment of cerebral palsy in children. Design: A prospective randomized parallel-controlled trial. Methods: One hundred and ten children with cerebral palsy who will receive treatment in the First Affiliated Hospital of Dalian Medical University, China, will be randomly divided into five groups (n = 22 per group): control, nasal transplantation of UCMSCs, lumbar puncture transplantation of UCMSCs, nasal transplantation of NSCs, and lumbar puncture transplantation of NSCs. Cell transplantation will be correspondingly conducted in the latter four groups, with at least 1 × 107 cells per session, for two sessions within 4 weeks as one course, for a total of two courses. Outcome measures: Evaluations will be performed before cell treatment and at 1, 3, 6, 9, and 12 months after the completion of two treatment courses, including Gross Motor Function Measure (GMFM)-88, GMFM-66, Fine Motor Function Measure (FMFM), Modified Ashworth Scale, the Gesell Developmental Schedules, electroencephalogram examination and brain imaging examination. The primary outcome of this study is the overall objective response rate calculated on the basis of the changes in GMFM-88 total score and GMFM-66 reference percentile. The secondary outcomes of this study include the duration of response and progression-free survival based on the GMFM-88 total score change and GMFM-66 percentile change as well as overall survival, FMFM score, Modified Ashworth Scale score, the Gesell Developmental Schedules score, electroencephalogram examination and brain imaging examination. Discussion: This study aims to verify the efficacy and safety of UCMSCs/NSCs transplantation for the treatment of cerebral palsy in children, providing experimental data to support UCMSCs/NSCs therapy for cerebral palsy in clinical practice. Ethics and dissemination: Written informed consent will be given by legal guardians or authorized surrogates of children with cerebral palsy as well as donors or their legal guardians. Design of the trial was completed in November 2016, and registered with ClinicalTrials.gov in December 2016. Participant recruitment was initialized in March 2017, and is expected to last 2 years. Data collection and follow-up visit will end in June 2020, and data analysis will be completed in December 2020. The results of this study will be disseminated by publications in peer-reviewed journals. Trial registration: This trial was registered in the Clin","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78713313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}