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 analyzed in December 2018. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800014368). Protocol version (1.0).

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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 14^th, 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 14^th, 2016 (approval No. 2016101411). Patient recuritment for the preliminary study was performed during January to October 2017. Patient recuritment for this study will begin in June 2018. Data collection will end in December 2020. The current study will be performed from June 2018 to December 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be published at www.figshare.com. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800015669).

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Background and objectives: Newborns with perinatal risk factors and abnormal general motor quality assessment are at high risk of developing cerebral palsy. The treatment is earlier, the prognosis is better. This trial will investigate whether, combined with conventional early interventional therapy, the use of mouse nerve growth factor in high-risk infants can improve their motor and cognitive abilities. Design: This is a prospective, single-center, randomized, parallel, controlled, clinical trial. Methods: This trial will be conducted in the Department of Developmental Behavioral Pediatrics, the First Hospital of Jilin University, China. One hundred high-risk infants meeting the inclusion criteria will be recruited and randomized into control and treatment groups. Only participants in the treatment group will undergo the early treatment of mouse nerve growth factor via gluteus maximus injections, 20 μg per dose, once a day, 10 consecutive days per month. The treatment will last for 6 months. Both groups will receive standard early intervention therapies. Outcome measures: The primary outcome measure is the incidence of the developmental disorders cerebral palsy and non-cerebral palsy at the actual age or corrected age of 12 months. The secondary outcome measures are Gesell Developmental Schedule scores at the actual age or corrected age of 12 months, Gross Motor Function Measure score at 6 and 12 months of treatment, and adverse events during the trial. Discussion: If treatment with mouse nerve growth factor is found to be safe and effective for the high-risk infants, new options for the early-stage clinical treatment for such infants may be developed. Ethics and dissemination: This trial has been approved by the Ethics Committee of First Hospital of Jilin University of China [approval number: 2017 (2017-290)]. This trial was designed in August 2017. Ethics approval was done in October 2017. This trial was registered in November 2017. The recruitment of subjects began in December 2017. Data analysis will be finished in December 2021. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012774). Protocol version (2.0).

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Background and objectives: The precedents about the existence of bilateral modulatory neuronal pathways between vestibular nuclei and higher brain centers involved in mood regulation, plus previous reports of abnormal vestibular function in major depression, support the relevance of further investigation inquiring the role of the vestibular system in depression's physiopathology and vice versa. The aim of this investigation is to study the vestibular activity in major depression patients using the rotatory test technique. Methods: Totally 21 major depression subjects (average age 37.9 years) according to Diagnostic and Statistical Manual of Mental Disorders-V criterion, who scored 12 or more in the 21-item Hamilton Rating Scale for Depression (HRS-D21), and 20 control healthy subjects (average age 41.1 years) who scored less than 7 in the HRS-D21, were tested in the rotatory chair. The nystagmus (vestibular-ocular reflex consisting of ocular movements induced by the vestibular system), was registered by electronystagmography. For the quantification of right or left vestibular activity, we measured the nystagmus's slow phase velocity induced by right and leftward rotation of the chair correspondingly. Results: Depression group showed an asymmetric vestibular pattern of activity (right/left vestibular activity ratio = 0.77 ± 0.2), significantly different (P < 0.01) from healthy who presented symmetric vestibular function (right/left ratio = 1.1 ± 0.3). Conclusion: Major depressive patients show an abnormal pattern of vestibular activity with lower function at the right side compared to left. We discuss the meaning and the possible underlying physiopathologic mechanisms of this finding. Also, we raise the possibility to consider this particular kind of vestibular asymmetry as a potential biomarker of major depression. Trial registration: ClinicalTrials.gov identifier: NCT03421847.

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Background and objectives: As degenerative changes in dopaminergic neurons occur only in the substantia nigra and striatum of patients with Parkinson's disease (PD), cellular therapy is suitable for this condition. However, previous clinical studies using stem cells for treatment of PD have short follow-ups. Thus, studies with longer follow-ups are required to further investigate the efficacy of stem cell-based therapy. Design: A non-randomized controlled trial. Methods: Ninety eligible PD patients will be recruited from the Department of Neurology at the Affiliated Hospital of Xuzhou Medical University, China. These patients will be assigned to three groups according to each patient's or their legal guardians’ wishes (n = 30 per group). In the control group, 12-week routine drug treatment will be performed. In intrathecal administration and intravenous administration groups, intrathecal administration of autologous neural stem cells (NSCs) into the subarachnoid space or intravenous administration of autologous NSCs will be performed once a week for 4 successive weeks in addition to the 12-week routine drug treatment. Outcome measures: The primary outcome measure is symptom improvement rate at 36 months post-treatment. Secondary outcome measures are nigrostriatal dopamine content, α-synuclein content in blood and cerebrospinal fluid, Barthel index, and safety indicators. Discussion: This study will be performed to demonstrate efficacy of autologous NSC transplantation as a prospective treatment for PD and investigate differences between intrathecal and intravenous transplantation routes, thus providing objective quantitative evidence for clinical applications. Ethics and dissemination: This study was designed in July 2017. Ethics approval from Medical Ethics Committee of the Affiliated Hospital of Xuzhou Medical University of China was achieved on December 22, 2017 (approval No. XYFY2017-KL052-01). The study protocol was registered on December 25, 2017. Patient recruitment began in January 2018 and will end in January 2019. Each patient will be followed up for 36 months. Follow-ups will be completed in January 2022. Data analysis will be performed in July 2022. Results will be disseminated by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17014141). Protocol version (1.0).

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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).

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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).

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