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  Most popular articles (Since October 16, 2015)

 
 
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STUDY PROTOCOL
Role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study
Maruli Simangunsong, Bihantoro , Zola Wijayanti, Echa Aisyah, Novarida Mustikawati, Raymond R Tjandrawinata, Prihatini Hendri, Nurul Hidayah, Liana W Susantos, Fenny , Deni Purnama
April-June 2016, 1(2):50-61
DOI:10.4103/2468-5577.181235  
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.
  1,890 175 -
Efficacy and safety of ozone therapy administered by autologous blood transfusion for acute ischemic stroke: study protocol for a multi-center open-label large-sample parallel randomized controlled trial
Jing Qiu, Hui-sheng Chen
April-June 2016, 1(2):37-42
DOI:10.4103/2468-5577.181233  
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.
  1,739 229 -
Electroencephalographic changes following trigeminal nerve stimulation for major depressive disorder: study protocol for a randomized sham-controlled trial
Alisson Paulino Trevizol, Pedro Shiozawa, Quirino Cordeiro
October-December 2016, 1(4):164-169
DOI:10.4103/2468-5577.193143  
Background: Major depressive disorder (MDD) is one of the most common psychiatric disorders. Trigeminal nerve stimulation (TNS) is a novel neuromodulation technology with impressive initial results in the treatment of MDD that lacks a better evaluation of neurobiological mechanisms of action. Methods/Design: This is a two-arm, randomized, double-blind, sham-controlled trial to evaluate the effect of TNS on severe MDD through quantitative electroencephalography (QEEG) pre and post intervention. Forty-four patients diagnosed with severe MDD will be randomly assigned to either a 10-session treatment protocol of real TNS or a 10-session treatment protocol of sham TNS. Outcome measures will be evaluated at baseline, at the end of the stimulation protocol and 30 days after the end of the 10-day treatment period. The primary outcome is changes in the previously established frequency band ranges in QEEG during resting state. The secondary outcome is heart rate variability for better evaluation of the sympathetic and parasympathetic changes after TNS. Discussion: Due to the high prevalence of MDD, the limited effect of antidepressant medications, the high rate of intolerable adverse events, and the high rate of refractoriness, we believe non-invasive neuromodulation strategies, e.g., TNS can be a useful tool for the treatment of MD. The evaluation of the effect of TNS with QEEG before and after stimulation may help us clarify the mechanisms involved in the clinical responses. Trial registration: ClinicalTrials.gov identifier: NCT02562703, registered on 25 September 2015. Ethics: This study protocol has been approved by the institutional review board (IRB) (approval number: 30960814.7.0000.5479) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Patients will sign an informed consent prior to participation in the study.
  1,749 117 -
Migraine prevention by noninvasive electrical fastigial nucleus stimulation: a multi-center, randomized, double-blind, sham-controlled trial
Juan Yang, Shu Ou, Jie Zhang, Wei-wei Dong, Jian Wang, Jin-he Lou
July-September 2016, 1(3):107-115
DOI:10.4103/2468-5577.187076  
Background: Migraine is a global disease with a high morbidity rate, and while there is medication for migraine prevention, it has many side effects. Thus there is a need to find a non-drug therapy to prevent migraine in patients with frequent attacks of migraine, severe pain, and poor drug control. Cortical spreading depression (CSD) is an important pathological mechanism behind migraine. Electrical fastigial nucleus stimulation (FNS) can reportedly inhibit the occurrence and propagation of CSD, and therefore can be used to prevent migraine. Methods/Design: This is a prospective, multi-center, randomized, double-blind, sham-controlled trial. It will be performed at Chengdu Second People's Hospital, the Second Affiliated Hospital of Chongqing Medical University, Chongqing Fourth People's Hospital, the First Affiliated Hospital of Chongqing Medical University, and Chongqing People's Hospital, China. The approach is to randomly allocate 80 eligible migraine patients to undergo 3 months of either noninvasive electrical FNS (pulse width 90 μs, frequency 1.8 kHz, and output current 10 mA) or ineffective sham-stimulation (using the same stimulation equipment; pulse width 90 μs, frequency 10 kHz, and output current 0.18 mA). The primary outcomes are: change in monthly migraine days between the run-in month and 3 rd month of treatment, and percentage of patients having at least a 50% reduction of monthly migraine days in the 3 rd month of treatment. The secondary outcomes are: change between average monthly migraine days across 3 months of treatment and monthly migraine days in the 3 rd month of treatment, Visual Analogue Scale score in the 3 rd month of treatment, change in monthly anti-migraine drug use between the run-in month and 3 rd month of treatment, migraine disability assessment questionnaire score, accompanying symptoms, and adverse reactions. Discussion: In previous studies on electrical FNS for the treatment of various brain injuries, sample sizes have been small with inclusion of only a small number of institutions and non-rigorous trial protocols. Accordingly, the data obtained were not very reliable. In this study, we will validate the efficacy of electrical FNS in migraine prevention using a multi-center, randomized, double-blinded, controlled trial. Our findings will provide evidence for clinical application of this method. Trial registration: The trial protocol was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) (registration number: ChiCTR-ICR-15006273) on 5 April 2015. Ethics: This trial was approved by the Ethics Committee of Chengdu Second People's Hospital, China on 9 April 2015 (approval number: 2015010), and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.
  1,720 133 -
RESEARCH ARTICLE
Spectrum of MRI brain findings in subacute sclerosing panencephalitis
Sidra Kaleem Jafri, Yousuf Husen, Khalid Ahmed, Shahnaz Hamid Ibrahim
October-December 2017, 2(4):124-128
DOI:10.4103/2542-3932.217490  
Background and objectives: Subacute sclerosing panencephalitis (SSPE) is a progressive catastrophic neurodegenerative disease because of persistent measles viral infection in the brain. This study was designed to determine the spectrum of magnetic resonance imaging (MRI) findings in subacute sclerosing panencephalitis. Design: Case series. Methods: We described the brain MRI findings in 20 pediatric patients with confirmed SSPE with their clinical and electroencephalogram (EEG) correlates. This study was conducted at Aga Khan University Hospital, Karachi, Pakistan between January 2006 and June 2016. Diagnosis of SSPE was on the basis of the clinical signs and symptoms, the characteristic EEG patterns (burst suppression in the early stage and a diffuse, random, slow arrhythmia pattern in the late stage), and high titers of measles antibody in the cerebro-spinal fluid. Results: The mean age at presentation was 7.4 ± 3.3 years. MRI abnormalities included diffuse white matter changes (n = 8), subcortical T2 hyperintesities in both grey and white matter in 1 patient and the brainstem changes in 2 patients. MRI was normal in 8/20 patients. Magnetic resonance spectroscopy (MRS) was performed in 4 patients out of whom 1 patient showed reduced N-acetyl aspartate (NAA) peak with elevated choline peak and inverted doublet lactate peak, 1 showed only reduced NAA, 1 showed isolated choline peak and 1 patient had a normal MRS. Conclusion: MRI brain to date is supportive in understanding the pathology of SSPE. MRI can be normal in patients with SSPE if done early on at the start of the disease.
  1,445 382 -
STUDY PROTOCOL
Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial
Yue Yun, Ling Pei
January-March 2016, 1(1):18-24
DOI:10.4103/2455-7765.173005  
Background: Favorable quality of recovery from general anesthesia in neurosurgical patients is an important goal for anesthesiologists. Dexmedetomidine is an emerging anesthetic adjuvant characterized by a stable hemodynamic recovery period, and neither its sedative nor analgesic effects influence evaluation of neurological function. We hypothesize that a bolus injection of low-dose dexmedetomidine during general anesthesia within minutes before the end of surgery in patients undergoing craniotomy can improve the quality of recovery from general anesthesia, thereby benefitting the evaluation of early-stage neurological function after surgery. Methods/Design: Patients with supratentorial tumors who have undergone craniotomy under general anesthesia at the Department of Neurosurgery, First Affiliated Hospital of China Medical University are included in this randomized controlled trial. A sample size of 150 patients is needed. Patients in the experimental group are randomly assigned to receive intravenous bolus injection of low- and medium-dose dexmedetomidine (0.4 and 0.8 ΅g/kg, respectively). Patients in the control group receive equal doses of physiological saline. The primary outcome of the study is the quality of recovery from general anesthesia, including awakening time, degree of sedation, spontaneous breathing recovery time, and coughing and bucking at the time of tracheal extubation. Secondary outcomes include postoperative analgesic effects, hemodynamic indices, anesthesia time, operation time, and neurological function assessment. Discussion: The results from this trial will provide optimal evidence for intravenous bolus injections of dexmedetomidine at a dose that can improve the quality of recovery from general anesthesia after craniotomy for supratentorial tumors. Trial registration: ClinicalTrails.gov identifier: NCT02007798; registered on 6 December 2013.
  1,606 179 -
RESEARCH ARTICLES
Description of Guillain-Barre syndrome on the basis of clinical features using Hughes scoring system among children in Karachi, Pakistan
Prem Chand, Farida Jan, Sidra Kaleem, Mohammad Tahir Yousafzai, Shahnaz Ibrahim
April-June 2017, 2(2):45-49
DOI:10.4103/2542-3932.205193  
Background: Guillain-Barre syndrome (GBS) is an acquired inflammatory polyneuropathy characterized by rapidly progressive symmetrical flaccid limb weakness and areflexia. Here, we aimed to describe GBS on the basis of clinical features using Hughes scoring system (HSS) in children. Methods: We conducted a descriptive study, retrieving medical records of children between 2–16 years old admitted with GBS during January 2011–December 2013 at Aga Khan University Hospital, Karachi. Information on demographics, predisposing factors of GBS, clinical features at presentation, investigations, managements, short- and long-term outcomes were recorded on data extraction sheet. Ethical approval was obtained before data collection. Results: Totally 31 children with GBS (21 males) were admitted during the study period. The mean age was 6.7 years. Thirteen cases were seen in summer (January–October) followed by 11 in spring (March–May) and 7 in winter (November–February). Preceding illnesses including upper respiratory tract infections in 15 and diarrhea was seen in 4 patients. None of the patients had history of prior immunization. The nerve conduction study/electromyography showed acute inflammatory demyelinating polyradiculoneuropathy in 18 (58%), acute motor axonal neuropathy in 8 (25.8%), acute motor and sensory axonal neuropathy in 3 (9.7%) and Miller Fisher syndrome in 2 (6.5%) patients. Twenty-one patients had received intravenous immunoglobulin, four had plasmapharesis, four had both while two patients received none of these. Ventilator support was required by seven patients. Tracheostomy was performed on two patients. The HSS was calculated at 3-month follow-up. Nineteen children (61.2%) had an HSS score of 0–1, eight had a score of 2–5 (25.8%), and four patients were lost to follow-up. Conclusion: HSS is a good tool to identify and follow children with GBS. More than two-thirds of the patients had recovered complete mobility at 3-month follow-up.
  1,483 169 -
STUDY PROTOCOL
Postoperative sedation by intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage: study protocol for a randomized parallel-cohort controlled trial
Chao-liang Tang, Jun Li
January-March 2016, 1(1):6-11
DOI:10.4103/2455-7765.173000  
Background: Cerebral hemorrhage is often complicated by conscious disturbance and restlessness regardless of the size or location of the hemorrhage, and sedation is often necessary. Dexmedetomidine has dose-dependent sedative, anxiolytic and analgesic effects. It is suited to patients undergoing mechanical ventilation for traumatic brain injury; however, its sedative effects cannot easily be controlled in patients breathing spontaneously. We will investigate the safety and efficacy of postoperative intranasal dexmedetomidine in patients undergoing craniotomy for hypertensive cerebral hemorrhage. Methods/Design: A randomized parallel-cohort controlled trial will be performed at the South District of Anhui Provincial Hospital, China. Patients with hypertensive cerebral hemorrhage will be randomly divided into groups treated with 0.9% normal saline (placebo), or dexmedetomidine 1 or 1.5 μg/kg. Study drug, either undiluted dexmedetomidine 1 or 1.5 μg/kg (dexmedetomidine group) or equal volume of 0.9% normal saline (placebo group), will be administered immediately to each naris as drops after craniotomy for evacuation of hematoma. Primary outcomes include systolic blood pressure, diastolic blood pressure, heart rate, peripheral oxygen saturation, intracranial pressure, Glasgow Coma Scale score, the level of inflammatory markers in the cerebrospinal fluid, and the levels of malondialdehyde, superoxide dismutase, 4-hydroxynonenal, neurotensin, 8-hydroxy-2'-deoxyguanosine and corticosteroid in serum. Secondary outcomes are volume of hematoma, body weight, duration of surgery, duration of anesthesia, blood loss, urine output and length of hospital stay. Discussion: The results of this trial will provide evidence for the safe and effective postoperative use of intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage who are not mechanically ventilated. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) identifier: ChiCTR-IPR-15006668; registered on 30 June 2015. Ethical issues: The trial was approved by Clinical Research Ethics Committee of Anhui Provincial Hospital, China (permission No. 2015 ethics No. 07).
  1,458 178 1
The optimal time window for the use and dosage of nimodipine for acute massive cerebral infarction: study protocol for a randomized controlled trial
Run-hui Li
January-March 2016, 1(1):1-5
DOI:10.4103/2455-7765.172998  
Background: A neuroprotective effect of nimodipine on acute cerebral infarction has been confirmed, but there are few reports regarding the therapeutic effect of nimodipine on acute massive cerebral infarction. There is also no consensus on the optimal time window for the use and dosage of nimodipine. This trial is planned to answer these questions using a double-blind randomized controlled design. Methods/Design: This is a double-blind randomized controlled trial. The experiments will be conducted in the Department of Neurology, Central Hospital Affiliated to Shenyang Medical College of China. One hundred patients with acute massive cerebral infarction will be randomly assigned to a control group and a treatment group. Patients in the control and treatment groups will receive intravenous infusion of citicoline and intravenous infusion of nimodipine (10 mg/d) respectively, for 7 consecutive days. Simultaneously, to determine the appropriate time window for treatment with nimodipine, patients in the treatment group will be divided into four subgroups according to the time of nimodipine administration: < 3 hours, 3-6 hours, 6-24 hours, and > 24 hours. The main outcome measures are: the National Institutes of Health Stroke Scale and the Rankin scale will be used to assess the severity and recovery of neurological impairment, respectively. Cranial computed tomography and magnetic resonance imaging will be used to evaluate brain lesions and the Barthel index will be used to assess the activities of daily living. Secondary outcome measures are heart rate and blood pressure. Discussion: It is hoped that the experimental results can determine the best application time window and dosage of nimodipine for acute massive cerebral infarction. Trial registration: ClinicalTrials.gov identifier: NCT02248233; registered on 22 September 2014.
  1,448 183 -
Effect of intravenous acetaminophen on post-operative opioid-related complications: study protocol for a randomized, placebo-controlled trial
Wael Saasouh, Nelroy Jones, Taylor Stang, Karen Hovsepyan, Christine Chang, Alparslan Turan
October-December 2016, 1(4):154-163
DOI:10.4103/2468-5577.193142  
Background: Unrelieved post-operative pain leads to physiological and psychological consequences which worsen outcomes. Patients still report a 31% incidence of severe pain and 47% incidence of moderate pain after surgery. Multimodal analgesia aims to improve satisfaction while reducing side effects. Opioids are the most common treatment for post-operative pain; however, acute tolerance and opioid-induced hyperalgesia increase opioid requirements and the risk of side effects. Previous studies with acetaminophen have shown consistent and clinically important opioid-sparing effects but were unable to demonstrate significant reductions in opioid-related adverse events (inadequate sample sizes, poorly monitored complications). Specifically, we propose to test the primary hypothesis that total duration of hypoxia (defined as saturation of peripheral oxygen (SpO 2 ) < 90%) is less in patients receiving intravenous acetaminophen than placebo. Methods/Design: A total of 528 patients undergoing elective open or laparoscopic abdominal surgery will be included in this prospective, randomized, double-blinded, placebo-controlled trial. Patients who have renal disease, liver disease, acetaminophen allergy, are on warfarin therapy, or are receiving regional blocks will be excluded. The incidence and duration of hypoxic events will be the primary outcome of the study. Secondary outcomes include opioid consumption, pain scores, post-operative nausea and vomiting, sedation, fatigue, respiratory rate, movement, and cost-benefit analysis. We will use a ViSi mobile device (Sotera Wireless, San Diego, CA, USA) that will provide continuous non-invasive pulseoximetry, blood pressure, skin temperature, and patient position. Respiratory function will be measured using an ExSpiron (Respiratory Motion Inc., Waltham, MA, USA) monitor which provides continuous non-invasive monitoring of tidal volume, respiratory rate, and minute ventilation. Discussion: The outcomes will reveal the effect of peri-operative IV acetaminophen use on post-operative opioid-related complications. Continuous non-invasive monitoring of vital signs is expected to accurately assess opioid-related complications after major abdominal surgery and provide reliable results correlated with opioid use. The use of novel technology in the post-operative setting permits the collection of a dense amount of data and eliminates gaps in post-operative vital sign measurements. Trial registration: ClinicalTrials.gov identifier: NCT02156154, registered on 3 June 2014. Ethics: The study protocol was approved by the Cleveland Clinic Institutional Review Board (IRB) on 28 April 2014, approval number 14-241. Informed consent: Written informed consent will be obtained from participants or their guardians.
  1,286 323 -
Intensive versus nonintensive insulin therapy for hyperglycemia after traumatic brain injury: study protocol for a randomized controlled trial
Wen-xue Wang, Ai-min Li, Jian-wei Wang, Xin Kang, Guang-hui Fu, Yu-liang Liu
January-March 2016, 1(1):12-17
DOI:10.4103/2455-7765.173001  
Background: Hyperglycemia after traumatic brain injury is a physiological and metabolic disorder that may further aggravate secondary injury to the brain. Various experiences in the effective treatment of hyperglycemia after traumatic brain injury have been described. For example, the early use of intensive insulin therapy can control the blood glucose concentration within the target range, which has a direct protective effect on severe traumatic brain injury. However, some studies have arrived at different conclusions. Therefore, we aim to verify the therapeutic efficacy of intensive insulin therapy versus nonintensive insulin therapy on hyperglycemia after severe traumatic brain injury. Methods/Design: A randomized, controlled, double-blind study has been designed for completion at Oriental Hospital of Lianyungang, China. Sixty patients with hyperglycemia after severe closed traumatic brain injury will be randomized into an intensive insulin therapy group and a nonintensive insulin therapy group. The intensive insulin therapy group will then be divided into three subgroups based on the following target blood glucose levels: 4.4-7.0 mM (strict control group), 7.1-10.0 mM (moderate control group), and 10.1- 3.0 mM (slight control group). In the intensive insulin therapy group, the blood glucose levels will be monitored and controlled using the Yale Insulin Infusion Protocol, and a micropump will be used for intravenous injection of insulin. The nonintensive insulin therapy group will be given subcutaneous insulin injections. The primary endpoint will be the blood glucose levels, and the secondary endpoints will be mortality, activities of daily living, and prognosis. Discussion: This study will be powered to confirm the advantages of intensive insulin therapy in controlling blood glucose levels, reducing mortality, and improving prognosis in patients with hyperglycemia after severe traumatic brain injury. Trial registration: ClinicalTrials.gov identifier: NCT02161055; registered on 5 June 2014.
  1,445 147 -
Correlating single nucleotide polymorphisms in vitamin D metabolism-related genes to autism susceptibility and vitamin D treatment: study protocol of a non-randomized parallel-cohort controlled trial
Ling Shan, Bing Wang, Xiao-lan Hu, Fei-yong Jia
January-March 2016, 1(1):31-36
DOI:10.4103/2455-7765.173011  
Background: Vitamin D plays a unique role in promoting embryonic and neural development, cerebral immunological regulation, and influencing neural differentiation and gene regulation. Vitamin D deficiency may be one of the environmental risk factors for autism spectrum disorder. This trial has two purposes: (1) correlating single nucleotide polymorphisms of vitamin D metabolism-related key enzymes to autism susceptibility; and (2) investigating the therapeutic effect of exogenous vitamin D on autism spectrum disorder. Methods/Design: A non-randomized parallel-cohort controlled trial. Sixty children with autism spectrum disorder who receive treatment at the Department of Pediatric Neurological Rehabilitation, First Hospital, Jilin University, China, are included. Sixty healthy controls are also recruited from those undergoing a physical examination. For the first purpose, primary outcomes include vitamin D metabolism and single nucleotide polymorphisms of related genes. Vitamin D level in peripheral blood is the secondary outcome. For the second purpose, 60 children with autism spectrum disorder are treated with exogenous vitamin D supplementation. Prior to and 1 month after exogenous vitamin D supplementation, primary outcomes are evaluated, including the Childhood Autism Rating Scale (CARS) score, Autism Behavior Checklist (ABC) score, the Gesell Developmental Schedules (GDS) score, Clinical Global Impression Scale-(CGI) for severity of illness (SI), global improvement (GI), and efficacy index (EI) scores. Again, vitamin D levels in peripheral blood are evaluated as the secondary outcome. Discussion: This trial is sufficiently powered to provide scientific evidence for the genetic and pathological mechanism of autism spectrum disorder in children that lack vitamin D. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) identifier: ChiCTR-TRC-14004499; registered on 30 November 2013. Ethical issues: This trial was approved by the Medical Ethics Committee, First Hospital of Jilin University, China (approval No. 2013-192). The trial protocol will be performed in accordance with the Declaration of Helsinki.
  1,340 127 -
Mood stabilizers and/or antipsychotic drugs for the treatment of manic episodes in bipolar I disorder: study protocol for a randomized controlled trial
Kangguang Lin, Ting Li, Kun Chen, Weicong Lu, Jiehua Kong, Guiyun Xu
April-June 2016, 1(2):76-82
DOI:10.4103/2468-5577.181238  
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.
  1,338 128 -
Effects of ultra-low frequency transcranial magnetic stimulation on motor function and intelligence of children with spastic cerebral palsy: study protocol for a randomized parallel-cohort controlled trial
Jun-yan Feng, Ling Shan, Bing Wang, Fei-yong Jia
January-March 2016, 1(1):25-30
DOI:10.4103/2455-7765.173008  
Background: Ultra-low frequency transcranial magnetic stimulation is a novel transcranial magnetic stimulation method that was developed based on the biological resonance principle and has been used in combination with an encephalofluctuograph. It can be used to treat brain diseases by regulating the brain electrical activity of various neurotransmitters, thereby overcoming the shortcomings of conventional transcranial magnetic stimulation. Nevertheless, stimulation intensity, frequency, protocol, and curative effects should be considered. Ultra-low frequency transcranial magnetic stimulation has been widely used to treat insomnia and several studies have reported on the use of ultra-low frequency transcranial magnetic stimulation for the treatment of cerebral palsy. Methods/Methods: This is a randomized, parallel-cohort controlled trial. Patients with spastic cerebral palsy, aged 2-4 years, are included in this trial and assigned to two groups. In the control group, conventional rehabilitative treatment methods, including exercise therapy, Chinese traditional manipulation, and muscle fiber excitation are used. In the treatment group, in addition to routine rehabilitative treatment methods, ultra-low frequency transcranial magnetic stimulation is used. After 1 and 3 months of treatment, the outcomes are evaluated. The primary outcomes of the trial include Gross Motor Function Measure (GMFM) scores, Fine Motor Function Measure (FMFM) scores, and Wechsler Intelligence Scale for Children (WISC) scores. Discussion: The trial will provide clinical scale data for the use of ultra-low frequency transcranial magnetic stimulation to improve motor function and intelligence in child patients with spastic cerebral palsy. Trial registration: Chinese Clinical Trial Registration identifier: ChiCTR-TRC-14004706; registered on 26 May 2014. Ethical issues: This trial was approved by the Medical Ethics Committee, First Hospital, Jilin University, China (approval No. 100818-062). Signed written informed consent will be obtained from each subject.
  1,303 147 3
RESEARCH ARTICLE
Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy prolong the therapeutic effects of single ketamine infusion on post-traumatic stress disorder and comorbid depression: a pilot randomized, placebo-controlled, crossover clinical trial
Basant K Pradhan, Irving W Wainer, Ruin Moaddel, Marc C Torjman, Michael Goldberg, Michael Sabia, Tapan Parikh, Andres J Pumariega
July-September 2017, 2(3):80-90
DOI:10.4103/2542-3932.211589  
Background and objectives: Trauma memories lay at the core in etiopathogenesis of post-traumatic stress disorder (PTSD). Using pharmacological and cognitive behavioral treatments that specifically target trauma memories can improve the outcome. Ketamine has been shown to rapidly improve symptoms in PTSD and comorbid depression, but unfortunately these effects are short-lived. Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy is a type of mindfulness based cognitive behavioral therapy that targets the trauma memories. TIMBER psychotherapy in combination with (R,S)-ketamine are increasingly used to treat PTSD and comorbid depression. This study aims to determine if the combination of (R,S)-ketamine chemotherapy and TIMBER psychotherapy would produce a positive synergistic response in patients with PTSD. Design: This is a randomized, placebo-controlled, cross-over clinical study. Methods: Because response to ketamine alone is short-lived, this study combined TIMBER with a single infusion of 0.5 mg/kg (R,S)-ketamine to sustain its therapeutic effects. Ten patients with chronic and refractory PTSD were randomly assigned to two groups (n = 5 each): TIMBER-K group patients received ketamine infusion in combination with 12 TIMBER sessions (3 sessions in the first week followed by 9 sessions conducted on a weekly basis) and TIMBER-P group patients received placebo (normal saline infusion) in combination with 12 TIMBER sessions. The patients in the TIMBER-P group were switched to those in the TIMBER-K group after they experienced a sustained relapse. Outcome measures: PTSD Checklist (PCL), Clinician Administered PTSD Scale for DSM-IV (CAPS), the 17-item Hamilton Rating Scale for Depression (Ham-D-17, clinician rated), Beck Anxiety Inventory (BAI), and Montreal Cognitive Assessment (MoCA) at baseline and 8 hours after infusion were used to investigate if ketamine selectively affected trauma memories leaving the general memory intact. The mindfulness interventions in TIMBER were personalized based on subject's scores on Assessment Scale for Mindfulness Interventions which was administered at baseline, and after 5 sessions and 9 sessions (completion) of TIMBER. In this study, scores on CAPS and PCL scales were the primary outcome measures. Results: In the acute phase trial ( first 3 months after infusion), nine out of 10 subjects showed robust response in primary outcome measures (PCL and CAPS scores for PTSD) and in the secondary outcome measures (Ham-D-17 and Beck Anxiety Inventory for depression and anxiety respectively) with a sustained response of 31.78 ± 18.29 days. The TIMBER-K group had a more sustained response (33 ± 22.98 days) compared to the TIMBER-P group (25 ± 16.8 days, P = 0.545). After switch from TIMBER-P group to TIMBER-K, patients experienced significantly prolonged response (49 vs. 25 days, P = 0.028). There were no intolerable side effects or dropouts during the 18-month follow-up period. Conclusion: TIMBER psychotherapy augmented with low dose (R,S)-ketamine prolongs the therapeutic effects of the later and may be a valuable treatment option for PTSD. Trial registration: ClinicalTrials.gov identifier: NCT02766192
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STUDY PROTOCOL
Homeopathic prophylaxis for recurrent urinary tract infections following spinal cord injury: study protocol for a randomized controlled trial
Jürgen Pannek, Susanne Pannek-Rademacher, Mohinder S Jus, Jörg Krebs
October-December 2016, 1(4):191-195
DOI:10.4103/2468-5577.193147  
Background: Virtually many patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD). Although the most severe consequence of NLUTD, damage of renal function, can be treated effectively today, urinary tract infections (UTI) are the most common urologic problems in SCI patients. They severely impair the quality of life, and no evidence-based prophylaxis exists. The goal of this study is to assess the usefulness of adjunctive homeopathic treatment for the reduction of UTI in patients with SCI. Methods/Design: A prospective randomized controlled trial is designed to assess whether adjunctive treatment with classical homeopathy leads to a relevant reduction of the rate of UTI in patients with SCI. In addition, it will be assessed if homeopathic treatment will significantly improve patient satisfaction and quality of life. Fifty patients with SCI and recurrent (3 or more) UTI per year will be recruited from the patients of the neuro-urology of the Swiss paraplegic Centre in Nottwil, Switzerland. All patients will be randomly allocated into two groups: patients in the homeopathy group (n = 25) will receive standard of-care prophylaxis combined with homeopathic treatment; the control group (n = 25) will receive standard of-care prophylaxis alone. Standard of-care prophylaxis consists of cranberry products and urine acidification. Homeopathic treatment consists of a homeopathic medication; the remedy is chosen individually based on the homeopathic case taking. Patients do not routinely present to the homeopaths during the study, but can contact them if a UTI occurs during the course of the study. Primary outcome are the UTI rate, and secondary outcomes are quality of life and satisfaction with the treatment over a follow-up period of 1 year. Discussion: There is a high demand for effective UTI prophylaxis in patients with SCI, because UTI are associated with an increased morbidity and even mortality. The results of the study will significantly add to our knowledge not only about UTI prevention, but the clinical value of homeopathy. Trial registration: ClinicalTrials.gov identifier: NCT01477502, registered on 17 November 2011. Ethics: The "Ethikkommission Nordwest- und Zentralschweiz (EKNZ): PB_2016-00054" approved this study protocol. Informed consent: Patients will sign an informed consent prior to participation in the study.
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Scalp acupuncture twisting manipulation for treatment of hemiplegia after acute ischemic stroke in patients: study protocol for a randomized, parallel, controlled, single-blind trial
Liang Tian, Xiao-zheng Du, Jin-hai Wang, Zhen-chang Zhang, Qi Yan, Lei Wang, Run-jie Sun, Bo Yuan, Xing-lan Li, Ting-zhuo Zhang
July-September 2016, 1(3):98-106
DOI:10.4103/2468-5577.187075  
Background: Acupuncture can be used in clinical practice to promote motor recovery in patients with acute ischemic stroke and paralysis. It is an economical, safe, and effective method that can be easily implemented in clinical settings. However, although scalp acupuncture is an easy-to-perform micro-needle therapy, its efficacy in the treatment of hemiplegia resulting from acute ischemic stroke remains disputed. Methods/Design: This is a randomized parallel-controlled single-blind trial. It will be performed at the Department of Neurology, Second Hospital, Lanzhou University, China. Seventy-two patients suffering from acute ischemic stroke with paralysis will be randomly assigned to undergo 14 days of either conventional drug treatment (control group) or conventional drug treatment combined with scalp acupuncture that uses the twirling-needle method (once a day, 6 consecutive days followed by 1 day off per week). The primary outcome is the difference in National Institutes of Health Stroke Scale (NIHSS) scores between just after the stroke and 14 days after treatment. Secondary outcomes include motor recovery (assessed by the Fugl-Meyer Motor Scale) and activities of daily living (assessed by the Barthel index). Discussion: Objectively evaluating the efficacy of twirling-needle scalp acupuncture in the treatment of hemiplegia after acute ischemic stroke will provide evidence for assessing whether this method can improve motor recovery from hemiplegia resulting from acute ischemic stroke. Trial registration: This trial has been registered on 11 March 2016 in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-16008083). Ethics: This trial has been approved by Ethics Committee, Second Hospital, Lanzhou University of China (approval number: 2016A-003) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from the patients and their relatives.
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Diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) positron emission tomography/computed tomography in patients with brain gliomas: study protocol for an open-label single-arm clinical trial
Jie Zang, Hao Wang, Jing-jing Zhang, Zhao-hui Zhu
January-March 2017, 2(1):23-29
DOI:10.4103/2542-3932.198959  
Background: Gastrin-releasing peptide receptor is particularly expressed in gliomas, while the peptide bombesin [BBN(7-14)] has the complete C-terminal structure of human gastrin-releasing peptide. Glioma-specific imaging agents can therefore be constructed from BBN, for example 68Ga-NOTA-Aca-BBN(7-14). For consideration of the clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body positron emission tomography/computed tomography (PET/CT) study was designed to investigate the diagnostic effectiveness and safety of 68Ga-NOTA-Aca-BBN(7-14) in patients with brain gliomas. Methods/Design: This is an open-label single-arm clinical trial that will be conducted at Peking Union Medical College Hospital in Beijing, China. Thirty patients in suspicion of brain gliomas scheduled for surgical treatment will be recruited and subjected to PET/CT via intravenous injection of 68Ga-NOTA-Aca-BBN(7-14). The primary outcome measure will be the standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in brain glioma at 30 minutes after injection. Secondary outcomes include the diagnostic accuracy rate of 68Ga-NOTA-Aca-BBN(7-14) PET/CT, and adverse events after injection. Discussion: Diagnostic performance and safety assessment of 68Ga-NOTA-Aca-BBN(7-14) in brain gliomas will provide new insights into the specific PET/CT diagnosis of brain gliomas. Trial registration: ClinicalTrials.gov identifier: NCT02520882, registered on 2 August 2015. Ethics: This study protocol has been approved by the Ethics Committee of Peking Union Medical College Hospital in China (approval No. S-714), and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: An informed consent will be obtained from each patient or his/her guardian prior to participation in the study.
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Effects of dexmedetomidine combined with sodium creatine phosphate on inflammation, oxidative stress, and neurological function recovery in patients undergoing intracranial hematoma evacuation: study protocol for a multi-center, prospective randomized parallel-cohort controlled trial
Chao-liang Tang, Juan Li, Bo Zhao, Si Shi, Hao Shen, Zhong-yuan Xia
January-March 2017, 2(1):1-8
DOI:10.4103/2542-3932.198958  
Background: In treating intracranial hematoma, dexmedetomidine (Dex) exhibits neuroprotective effects by preventing cognitive decline, and sodium creatine phosphate (SCP) exhibits neuroprotective effects by reducing cell death, maintaining the blood-brain barrier and improving interstitial cerebral edema. Few studies have examined the effects of Dex combined with SCP on perioperative inflammation and oxidative stress response, or recovery of neurological function. Methods/Design: Here we propose a multi-center, prospective randomized parallel-cohort controlled trial, to be performed at Anhui Provincial Hospital and Renmin Hospital of Wuhan University, China. After screening against inclusion and exclusion criteria, 80 patients scheduled to receive intracranial hematoma evacuation will be randomly divided into control, Dex, SCP, and Dex + SCP groups, with 20 patients per group. Under general anesthesia, all patients will undergo craniotomy for hematoma removal. In the Dex and Dex + SCP groups, an intravenous bolus of Dex (0.6 μg/kg) will be administered 10 minutes before anesthesia induction and thereafter intravenous administration of Dex (0.4 μg/kg/h) will be given. In the SCP, and Dex + SCP groups, 1.0 g SCP will be administered 10 minutes before anesthesia induction. The primary outcome measure is the difference in postoperative 72-hour Glasgow Coma Scale (GCS) score and postoperative 12-hour GCS score. The secondary outcome measures include differences in postoperative 48-hour and 24-hour GCS scores and postoperative 12-hour GCS score; plasma levels of inflammatory and oxidative stress markers, and pathological changes in brain tissue before anesthesia induction and at the end of surgery; and physiological indices during surgery. Discussion: We evaluate whether results from the proposed study protocol will provide evidence that the use of Dex combined with SCP in patients undergoing intracranial hematoma evacuation is feasible. Trial registration: The study protocol was registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn/) on 11 December 2014 (registration number: ChiCTR-IPR-14005656). Ethics: The study protocol was approved by Ethics Committee, Anhui Provincial Hospital, China on 25 November 2014 (approval No. 2014-ethics-39) and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from patient's guardians or clients prior to enrollment in the clinical trial.
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Acupuncture combined with rehabilitation training improves pointed foot deformity and mental retardation in infants with spastic cerebral palsy: study protocol for a randomized controlled trial
Li-li Wang, Lin Du, Ling Shan, Han-yu Dong, Fei-yong Jia
April-June 2016, 1(2):69-75
DOI:10.4103/2468-5577.181237  
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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Efficacy and safety of glucocorticoids combined with hyperbaric oxygen therapy in the treatment of delayed encephalopathy after acute carbon monoxide poisoning: study protocol for a randomized controlled trial
Wen-ping Xiang, Hui Xue, Bao-jun Wang
January-March 2017, 2(1):15-22
DOI:10.4103/2542-3932.198961  
Background: About half of patients with acute carbon monoxide (CO) poisoning suffer from delayed post-anoxic encephalopathy. Days or weeks after apparent recovery from acute CO poisoning, patients present with sudden onset neurophysiological symptoms, mainly symptoms of dementia, with a high risk of permanent disability or death. Glucocorticoids not only regulate the biosynthesis and metabolism of blood glucose, fat, and protein, but also inhibit the immune response and exhibit anti-inflammatory, anti-toxic, and anti-shock effects. Glucocorticoids can improve the clinical symptoms of delayed encephalopathy; however, the therapeutic effects of glucocorticoids combined with hyperbaric oxygen therapy (HBOT) on delayed encephalopathy after acute CO poisoning are poorly understood. Methods/Design: This is a single-center, prospective, single-blind, randomized controlled trial, which will be performed at Baotou Center Hospital, China. A total of 120 eligible patients with delayed encephalopathy after acute CO poisoning will be randomly assigned to receive either basic treatment + HBOT + intravenous dexamethasone (trial group, n = 60) or basic treatment + HBOT (control group, n = 60). Intravenous injection of dexamethasone (10 mg, once a day, for 14 successive days) will be performed. HBOT (once a day, for 14 successive days) will be administered through a multi-place hyperbaric chamber that will be pressurized with 100% O 2 to 2-2.2 atmospheres absolute within 25 minutes, followed by 60 minutes of pressure stabilization, 10 minutes of resting, and 25 minutes of depressurization. The primary and secondary outcome measures of this study will be evaluated at baseline, 7, 14, 30, 60 and 90 days after treatment. The primary outcome measure is the Barthel Index of Activities of Daily Living change. The secondary outcome measures are Mini-Mental State Examination score, modified Ashworth Scale score and European Quality of Life-5 Dimensions questionnaire score, as well as adverse reactions and death rate. Discussion: This study will be conducted to analyze the clinical therapeutic efficacy and safety of glucocorticoids combined with hyperbaric oxygen therapy in the treatment of delayed encephalopathy after acute CO poisoning. Trial registration: This study protocol was registered with Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-16009743) on 5 November 2016. Ethics: This study protocol has been approved by the Ethics Committee, Baotou Central Hospital, China and will be performed in accordance with Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from patients' relatives prior to involvement in the clinical trial.
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Atorvastatin for treating spontaneous subarachnoid hemorrhage: study protocol for a randomized double-blind placebo-controlled trial
Jun-hui Chen, Yu-hai Wang
April-June 2016, 1(2):62-68
DOI:10.4103/2468-5577.181236  
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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Efficacy of spontaneous laughter in the post-operative treatment of pain and anxiety in children: study protocol for a randomized controlled trial
Magda Ruth Pérez Cervantes, Chiharu Murata, Volkmar Wanzke Del Angel
July-September 2016, 1(3):137-143
DOI:10.4103/2468-5577.187080  
Background: Studies have demonstrated the efficacy of laughter in contributing to a better quality of life. Strategies can be optimized to elevate tolerance to pain and to combat stress, thereby reducing the impacts of stress, such as the increase in arterial tension, reduction in perfusion of the non-motor organs, an increase in cellular metabolism, and a greater risk of infections. Despite the increased interest in this topic, there is still a need for more research, because many of such studies are limited by diverse methodological problems, such as lack of objective evaluations, clear distinction between laughter and humor, and establishment of dosage of the therapies (frequency and time). The objective of the current study is to determine the efficacy of spontaneous laughter in improving the post-operative prognosis for pediatric patients after minor surgery. Post-operative pain will be evaluated by the Visual Analog Scale, and urinary cortisol levels, duration of hospital stay, and anxiety by the State-Trait Anxiety Inventory for Children. Methods/Design: The study will be an open, randomized controlled trial, having three parallel arms: conventional post-operative management with analgesics; a second control group consisting of conventional treatment with an accompaniment that does not induce laughter; and an experimental group based on conventional treatment plus laughter therapy. Pediatric patients (6-14 years of age; n = 70 per group), hospitalized for minor surgery in a Mexico City hospital, will be randomly assigned to one of the three groups. Generalized linear models will be constructed to determine the adjusted effects of laughter therapy on the intensity of pain, anxiety, and duration of hospital stay. Discussion: To the best of our knowledge, no clinical trial to determine the effect of laughter therapy exists in which the effect of the vehicle is controlled. Here, we controlled this potential confounding factor by establishing a control group "accompaniment without laughter". As a secondary outcome variable, measurement of urinary cortisol levels will provide objective evidence to complement the subjective measurement of the pain as perceived by the patient. As a co-variable, the duration of effective laughter will provide greater robustness to this study. Trial registration: This trial was registered at ClinicalTrials.gov (identifier: NCT02563587) on 28 September 2015. Informed consent: The research protocol of this study has been approved by the Ethics Committee of the Hospital General Naval de Alta Especialidad de la Secretaría de Marina de la Armada de México (approval number: 076). This research adheres to the guidelines set forth in the NORMA Oficial Mexicana NOM-012-SSA3-2012 and in the Declaration of Helsinki.
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Efficacy of electroacupuncture at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine: study protocol for a randomized controlled trial
Jian Pei, Jun Wang, Qin-hui Fu, Wei-wei Dong, Xiao-xin You, Ming Dai, Yi Song
April-June 2016, 1(2):83-90
DOI:10.4103/2468-5577.181239  
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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RESEARCH ARTICLES
Hyperbaric oxygen therapy and comprehensive orthopedic treatment for incomplete traumatic spinal cord injury on the qinghai-tibet plateau: Study protocol for an open-label randomized controlled clinical trial
Qing Sun, Jian-feng Bao, Yu-lan An, Hui Lei, Jun Ma
April-June 2017, 2(2):50-57
DOI:10.4103/2542-3932.205194  
Background: Apoptosis secondary to ischemia and hypoxia is the main cause of spinal cord dysfunction. Because of the decrease in atmospheric pressure, patients living on the Qinghai-Tibet Plateau are in a hypoxic environment, which is very unfavorable for the recovery of spinal cord injury. Hyperbaric oxygen therapy can improve the postoperative function of patients with incomplete spinal cord injury, and its effect is better on the plateau than at normal altitudes. We performed a prospective randomized controlled clinical trial to observe the effect of hyperbaric oxygen therapy on traumatic spinal cord injury in patients living on the Qinghai-Tibet Plateau and are currently analyzing the results. Methods/Design: This prospective, open-label, randomized controlled clinical trial was performed at the Department of Spine Surgery, Affiliated Hospital of Qinghai University, China. In total, 164 patients with incomplete traumatic spinal cord injury were equally and randomly assigned to a control group and a hyperbaric oxygen therapy group. Patients in the control group were treated with pedicle screw fixation and decompressive laminectomy. In addition to the surgical treatment performed in the control group, patients in the hyperbaric oxygen group underwent hyperbaric oxygen therapy at 0.2 MPa once a day for four treatment courses. Ten treatment sessions constituted one course, and each course was separated by a 5- to 7-day rest interval. The primary outcome was the modified Barthel index to assess activities of daily living. The secondary outcomes were the American Spinal Injury Association (ASIA) impairment scale grade, sensory score, and motor score. The partial results demonstrated that after four treatment courses (55–61 days), the modified Barthel index and ASIA tactile, pain, and motor scores were higher in the hyperbaric oxygen group than in the control group. The ASIA grades were significantly different between the hyperbaric oxygen group and control group. The proportion of patients with ASIA grades D and E was higher in the hyperbaric oxygen group than in the control group. Discussion: The study design was finished in May 2012. Patient recruitment began in June 2012 and finished until February 2016.Data analysis will be finished in December 2017. In this trial, we aim to determine the efficacy of hyperbaric oxygen therapy on the treatment of incomplete traumatic spinal cord injury in patients living on the plateau and to provide clinical evidence for treating incomplete traumatic spinal cord injury in these patients. Trial registration: ClinicalTrials.gov identifier: NCT03112941. Ethics: The study protocol has been approved by Ethics Committee, Affiliated Hospital of Qinghai University, China in April 2012 (approval number: QHC011K). Informed consent: Written informed consent was obtained from relatives or legal representatives.
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