Background: Pointed foot deformity and mental retardation are common clinical manifestations in children with spastic cerebral palsy. Comprehensive rehabilitation training is performed in cerebral palsy children with mental retardation, but its clinical effect is not satisfactory. Acupuncture at acupoints related to the motor, sensory, foot-motor-sensory, language and equilibrium areas can promote intelligence and effectively relieve local muscle tension. We propose that acupuncture combined with rehabilitation training mitigates pointed foot deformities in children with spastic cerebral palsy and contributes to the development of intelligence. This prospective, randomized, controlled clinical study will test the above hypothesis. Functional magnetic resonance imaging will be utilized to observe the changes in acupuncture-activated brain regions and to elucidate the mechanisms of acupuncture in treatment of spastic cerebral palsy. Methods/Design: This is a prospective, randomized, controlled clinical trial. Sixty children with spastic cerebral palsy, hospitalized in the Out-Patient Clinic of the Department of Pediatric Neurological Rehabilitation, the First Hospital fo Jilin University of China, will be recruited for trial participation. All subjects will be equally and randomly divided into a treatment group and control group. Patients in the treatment group will be subjected to conventional rehabilitation training after acupuncture. Patients in the control group will receive conventional rehabilitation training alone. The treatment will last for 6 months. Primary outcomes will be Gross Motor Function Measure, ankle range of motion, Gesell Developmental Scale and surface electromyography. Secondary outcomes will be: modified Ashworth Scale of muscle spasticity, Fine Motor Function Measure, Gross Motor Function Classification System, and functional magnetic resonance imaging. Discussion: It is hoped that the experimental results can provide quantitative data for acupuncture combined with rehabilitation training in the treatment of spastic cerebral palsy. Trial registration: Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-15007633) on December 24, 2015.

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Background: In clinical practice, it is important to quickly and effectively treat manic episodes in patients with bipolar I disorder. Therefore, it is necessary to formulate an effective therapeutic protocol combining two or more drugs in order to rapidly alleviate symptoms within a short time frame (1 week). In this clinical trial protocol, the antipsychotics quetiapine, olanzapine and ziprasidone and the mood stabilizers valproate, oxcarbazepine and lithium will be used to treat manic episodes to investigate the efficacy and safety of these two types of drugs when used alone or in combination. Methods/Design: This trial will be performed at Guangzhou Brain Hospital, China. A total of 120 patients with bipolar I disorder, exhibiting manic or mixed episodes, will undergo two phases of medication. In the first phase, patients will be randomly assigned to receive oral valproate, oxcarbazepine, lithium, quetiapine, olanzapine or ziprasidone. In the second phase, combination drug treatment will be given, i.e., each patient will receive a combination of mood stabilizers and antipsychotics. Treatment will be given for a total of 6 weeks. Primary outcome measures will include changes in the Young Mania Rating Scale (YMRS) scores and dropout rates. Secondary outcome measures will include disease progression and the efficacy of treatment as evaluated with the Clinical Global Impression Scale, symptom severity as evaluated with the Global Assessment Scale, and anxiety and depression symptoms as evaluated with the Hamilton Anxiety Scale and the Hamilton Depression Scale, respectively. Discussion: This trial will provide preliminary evidence on the comparative efficacy and effectiveness of the commonly prescribed drugs, with attempts at optimizing pharmacological treatments of manic and mixed episodes. Trial registration: ClinicalTrials.gov identifier: NCT01893229; registered on 2 July 2013.

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Background: Acupuncture is a relatively safe treatment for pain, and its analgesic effects have been confirmed. Electroacupuncture (EA) has been widely used to treat migraine because of its continuous and highly controllable stimulation. However, few rigorously designed randomized controlled trials have evaluated the efficacy of EA at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine. Methods/Design: A prospective, single-center, single-blind randomized controlled trial will be performed at Longhua Hospital, Shanghai University of Traditional Chinese Medicine. Ninety-two patients with migraine will be randomly assigned to either undergo EA treatment (20 EA stimulations at the Hegu and Taichong acupoints; EA group, n = 46) or receive oral flunarizine (control group, n = 46). The primary outcome will be the Migraine Disability Assessment questionnaire score after 10 and 20 EA stimulations. The secondary outcomes will be the Medical Outcomes Study 36-item short form health survey score, Visual Analogue Scale score, and peripheral blood concentrations of plasma nitric oxide, calcitonin gene-related peptide, and nuclear factor-kappa B after 10 and 20 EA stimulations. Discussion: This trial is powered to investigate the efficacy of EA at the Hegu and Taichong acupoints in alleviating headache symptoms in patients with migraine and the interventional effects of this therapy on quality of life and social functioning to search for a more effective method of treating migraine. Trial registration: This trial protocol was registered at ClinicalTrial.gov (identifier: NCT02580968) on 30 July 2015. It was approved by the ethics committee of Longhua Hospital of Shanghai University of Traditional Chinese Medicine, China (approval No. 14401971300).

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Background: Oxaliplatin, a platinum-based cytotoxic agent, is a widely used chemotherapeutic agent. Small-sample clinical trials and animal experiments have shown that Jiawei Huangqi Guizhi Wuwu Tang (a decoction of five components, including Radix Astragali and Ramulus Cinnamomi) effectively reduces peripheral neuropathy caused by oxaliplatin, but no confirmation exists from a prospective, multicenter, randomized, controlled, blinded clinical trial. Methods/Design: We plan to conduct such a trial that will be completed at the Department of Oncology, Jiangsu Provincial Hospital of Integrated Medicine, China, the Center of Oncology of Nanjing Drum Tower Hospital, China, and the Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, China. Sixty-four patients with colorectal cancer stages IIa-IV will be equally randomized into either the HD6610 granule group (oxaliplatin chemotherapy plus HD6610 granules, a granular form for Jiawei Huangqi Guizhi Wuwu Tang) or the HD6610 placebo group (oxaliplatin chemotherapy plus HD6610 placebo made of bitters, food coloring, and starch). Primary outcomes are the scores of the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy and the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0. Secondary outcomes include the time of peripheral neuropathy occurrence, total neuropathy score, score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire, and survival time. Other outcomes will be evaluated before treatment as well as 1 and 2 weeks and 2, 4, 8, 12, 16, 20, and 24 months after treatment. Discussion: This study will provide evidence that the clinical application of HD6610 can reduce oxaliplatin-induced peripheral neuropathy. Trial registration: ClinicalTrials.gov identifier: NCT02590367; registered on 14 September 2015. Ethical approval: The study protocol was approved by Jiangsu Provincial Hospital of Integrated Medicine in China (approval No. 2014ZX (KT)-010-02).

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Background: There is still a lack of effective treatments for acute ischemic stroke. Our pre-clinical studies suggest that ozone therapy administered by autologous blood transfusion is a convenient and safe treatment for ischemic stroke, and is popular with patients, but its therapeutic benefits are not clear. We hypothesized that ozone therapy administered by autologous blood transfusion for ischemic stroke is safe and effective, and propose a protocol for a prospective, multi-center, open-label, large-sample, parallel, randomized, non-blinded controlled trial. Methods/Design: This will be a multi-center, open-label, large-sample, parallel, randomized controlled trial. We intend to recruit 5,000 patients with acute ischemic stroke in 30 centers (including General Hospital of Shenyang Military Region, China). Patients will be randomly allocated to a control group (n = 2,500; conventional stroke therapy) or an ozone therapy group (n = 2,500; ozone therapy administered in addition to conventional therapy). The primary outcome will be a modified Rankin Scale score 0-2 at 90 days. Secondary outcomes will be National Institute of Health Stroke Scale score at 14 days, blood lipid and glucose concentrations and coagulation function at 14 days, and the incidence of post-stroke pneumonia, recurrent stroke and other vascular events in the first 90 days after stroke. Discussion: We hope that our results will illuminate the therapeutic benefits of ozone therapy administered by autologous blood transfusion for acute ischemic stroke. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration No. ChiCTR-ICR-15007093) on 18 September 2015.

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Background: Arginylglycylaspartic acid (RGD) is a tripeptide composed of L-arginine, glycine, and L-aspartic acid that shows great affinity for the integrin α_v β₃ receptor. A RGD dimer labeled with ⁶⁸Ga, ⁶⁸Ga-BNOTA-PRGD2 was designed for positron-emission tomography/computed tomography (PET/CT) imaging post-stroke angiogenesis, which has rarely been used in the clinic. We aimed to perform a prospective open-label trial to validate the diagnostic value of ⁶⁸ Ga-BNOTA-PRGD2 PET/CT in post-stroke angiogenesis. Methods/Design: A self-controlled open-label clinical trial will be performed at the PET Center, Department of Nuclear Medicine, Peking Union Medical College Hospital, China. Fifty patients with stroke will undergo ⁶⁸ Ga-BNOTA-PRGD2 PET/CT, ¹⁸ F-FDG PET/CT, and magnetic resonance imaging (MRI) at 2 weeks, 3 months, and 1 year after stroke onset. Primary outcomes include the standardized uptake value (SUV) in the cerebral infarction area and the standardized uptake value ratio of the injured side to the contralateral side detected by ⁶⁸ Ga-BNOTA-PRGD2 PET/CT. Secondary outcomes include the safety of brain ⁶⁸ Ga-BNOTA-PRGD2 PET/CT used to evaluate post-stroke angiogenesis. Discussion: Findings from this trial will provide important reference evidence for use of ⁶⁸ Ga-BNOTA-PRGD2 PET/CT to evaluate post-stroke angiogenesis. Trial registration: ClinicalTrials.gov identifier: NCT01656785; registered on 1 August 2012.

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Background: In Indonesia, the incidence of stroke is growing rapidly every year and it becomes a burden to the government. Medications improving neurological function are required, in order to increase patient's quality of life. There were an enzyme (lumbrokinase) secreted from the alimentary tract of earthworm and it has anti-thrombotic and thrombolytic effect so that it can be beneficial in the management and prevention of stroke. DLBS1033 is a standardized bioactive protein fraction derived from Lumbricus rubellus through a patented technology of extraction. DLBS1033 has been shown to have antithrombosis and thrombolytic activities. The safety profile of DLBS1033 was also demonstrated in toxicology studies, animal studies, and in healthy adult subjects. Based on its mechanism of action and safety profile, DLBS1033 can be considered beneficial on acute ischemic stroke patients. Through this clinical study, we will evaluate the efficacy and safety of the product in acute ischemic stroke management. Methods/Design: This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in the management of acute ischemic stroke. Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 (as DLBS1033 group). Functional outcomes will be measured using the Modified Rankin Scale (MRS) and The Modified National Institutes of Health Stroke (mNIHSS). Discussion: The study is expected to be a medical breakthrough in acute ischemic stroke management. Therefore, the morbidity and mortality of this disease can be lowered. Trial registration: ClinicalTrials.gov identifier: NCT02362984; registered on 3 February 2015.

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Background: Animal studies have confirmed that statins have neuroprotective effects during and following a subarachnoid hemorrhage; however, the therapeutic effect of statins in humans remains controversial. The interpretation of data currently available on the clinical application of statins to spontaneous subarachnoid hemorrhage is limited by the small sample sizes used in the studies, making it difficult to draw valid conclusions regarding the multiple neuroprotective effects of statins. Thus, we propose to perform a randomized double-blind placebo-controlled parallel-group clinical trial to determine the effects of atorvastatin on spontaneous subarachnoid hemorrhage, apoptosis-related factors, and serum inflammatory factors in cerebrospinal fluid and to observe its neuroprotective effect mediated by relieving vasospasm. Methods/Design: This is a randomized parallel-group placebo-controlled double-blind clinical trial. This trial will recruit 300 patients with spontaneous subarachnoid hemorrhage from the Department of Neurosurgery, 101 ^st Hospital of PLA (Wuxi Taihu Hospital). These patients will be equally and randomly assigned to atorvastatin (40 mg/day) and placebo control groups. Outcomes will be evaluated at baseline, 3, 5, and 14 days after hemorrhage, and 6 months after discharge. The primary outcomes will be the results of computed tomography (CT) angiography combined with CT perfusion imaging and conventional CT. The secondary outcomes will be cerebrospinal fluid analysis, blood testing (tumor necrosis factor α, vascular endothelial growth factor, interleukin-6, and C-reactive protein levels), and the Hunt-Hess classification, the results of transcranial Doppler ultrasonography, and the scores on the Glasgow Coma Scale, the Glasgow Outcome Scale, and the National Institutes of Health Stroke Scale. Discussion: The results of this trial will provide data on the clinical application and neuroregenerative effect of atorvastatin in the acute stage of spontaneous subarachnoid hemorrhage. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-14005395) on 18 May 2014.

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