Sharp DJ, Scott G, Leech R (2014) Network dysfunction after traumatic brain injury. Nat Rev Neurol 10:156-166. Skillbäck T, Farahmand BY, Rosén C, Mattsson N, Nägga K, Kilander L, Religa D, Wimo A, Winblad B, Schott JM, Blennow K, Eriksdotter M, Zetterberg H (2015) Cerebrospinal fluid tau and amyloid-β1-42 in patients with dementia. Brain 138:2716-2731. Strathmann FG, Schulte S, Goerl K, Petron DJ (2014) Blood-based biomarkers for traumatic brain injury: Evaluation of research approaches, available methods and potential utility from the clinician and clinical laboratory perspectives. Clin Biochem 47:876888. Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttilä T (2009) Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol 66:382-389. Vergara VM, Damaraju E, Mayer AB, Miller R, Cetin MS, Calhoun V (2015) The impact of data preprocessing in traumatic brain injury detection using functional magnetic resonance imaging. Conf Proc IEEE Eng Med Biol Soc 2015:5432-5435. Vos PE, Jacobs B, Andriessen TM, Lamers KJ, Borm GF, Beems T, Edwards M, Rosmalen CF, Vissers JL (2010) GFAP and S100B are biomarkers of traumatic brain injury: an observational cohort study. Neurology 75:1786-1793. Wu X, Sha H, Sun Y, Gao L, Liu H, Yuan Q, Zhang T, Zhu J, Zhou L, Hu J (2011) N-terminal pro-B-type natriuretic peptide in patients with isolated traumatic brain injury: a prospective cohort study. J Trauma 71:820-825. Yang XH, Liu J, Liu WH (2012) Research progress on cognitive function rating scale in cerebral trauma patients. Huli Yanjiu 26:1827-1829. Yen HC, Chen TW, Yang TC, Wei HJ, Hsu JC, Lin CL (2015) Levels of F2-isoprostanes, F4-neuroprostanes, and total nitrate/nitrite in plasma and cerebrospinal fluid of patients with traumatic brain injury. Free Radic Res 49:1419-1430.
李建军，李建军，李建军(2014)脑外伤后网络功能紊乱。新牧师，神经，10:156-166。Skillbäck T, Farahmand BY, ros N C, Mattsson N, Nägga K, Kilander L, Religa D, Wimo A, Winblad B, Schott JM, Blennow K, Eriksdotter M, Zetterberg H(2015)痴呆患者脑脊液tau蛋白和淀粉样蛋白-β1-42的表达。大脑138:2716 - 2731。李建军，李建军，李建军，等(2014)基于血液的脑损伤生物标志物:临床和实验室角度的研究方法、可用方法和潜在效用评估。临床生物化学47:876888。李建军，李建军，张建军，张建军，等。(2009)脑脊髓液β -淀粉样蛋白42和tau蛋白在老年痴呆症发病机制中的应用。神经病学杂志66:382-389。Vergara VM, Damaraju E, Mayer AB, Miller R, Cetin MS, Calhoun V(2015)功能磁共振成像数据预处理对创伤性脑损伤检测的影响。[j] .中国生物医学工程学报，2015(5):532 - 535。Vos PE, Jacobs B, Andriessen TM, Lamers KJ, Borm GF, Beems T, Edwards M, Rosmalen CF, Vissers JL (2010) GFAP和S100B在创伤性脑损伤中的生物标志物研究。神经病学75:1786 - 1793。吴欣，沙慧，孙艳，高亮，刘慧，袁强，张涛，朱军，周磊，胡军(2011)孤立性创伤性脑损伤患者n端前b型利钠肽的前瞻性队列研究。[J]中国医学杂志(英文版)。杨晓华，刘杰，刘文辉(2012)脑外伤患者认知功能评定量表的研究进展。胡立延久26:27 -1829。颜慧慧，陈涛，杨振春，魏红军，徐建军，林春林(2015)颅脑外伤患者血浆和脑脊液中f2 -异前列腺素、f4 -神经前列腺素及总硝酸盐/亚硝酸盐水平。自由激进Res 49:1419-1430。
{"title":"Correction: Effects of cognitive behavioral therapy on white matter fibers of patients with obsessive-compulsive disorder as assessed by diffusion tensor imaging: study protocol for a parallel group, controlled trial","authors":"Xiang-yun Yang, Jia Luo, Jing Liu, Yun Ma, Zhi-hua Guo, Xiao-jie Yang, Zhanjiang Li","doi":"10.4103/2468-5577.193150","DOIUrl":"https://doi.org/10.4103/2468-5577.193150","url":null,"abstract":"Sharp DJ, Scott G, Leech R (2014) Network dysfunction after traumatic brain injury. Nat Rev Neurol 10:156-166. Skillbäck T, Farahmand BY, Rosén C, Mattsson N, Nägga K, Kilander L, Religa D, Wimo A, Winblad B, Schott JM, Blennow K, Eriksdotter M, Zetterberg H (2015) Cerebrospinal fluid tau and amyloid-β1-42 in patients with dementia. Brain 138:2716-2731. Strathmann FG, Schulte S, Goerl K, Petron DJ (2014) Blood-based biomarkers for traumatic brain injury: Evaluation of research approaches, available methods and potential utility from the clinician and clinical laboratory perspectives. Clin Biochem 47:876888. Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttilä T (2009) Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol 66:382-389. Vergara VM, Damaraju E, Mayer AB, Miller R, Cetin MS, Calhoun V (2015) The impact of data preprocessing in traumatic brain injury detection using functional magnetic resonance imaging. Conf Proc IEEE Eng Med Biol Soc 2015:5432-5435. Vos PE, Jacobs B, Andriessen TM, Lamers KJ, Borm GF, Beems T, Edwards M, Rosmalen CF, Vissers JL (2010) GFAP and S100B are biomarkers of traumatic brain injury: an observational cohort study. Neurology 75:1786-1793. Wu X, Sha H, Sun Y, Gao L, Liu H, Yuan Q, Zhang T, Zhu J, Zhou L, Hu J (2011) N-terminal pro-B-type natriuretic peptide in patients with isolated traumatic brain injury: a prospective cohort study. J Trauma 71:820-825. Yang XH, Liu J, Liu WH (2012) Research progress on cognitive function rating scale in cerebral trauma patients. Huli Yanjiu 26:1827-1829. Yen HC, Chen TW, Yang TC, Wei HJ, Hsu JC, Lin CL (2015) Levels of F2-isoprostanes, F4-neuroprostanes, and total nitrate/nitrite in plasma and cerebrospinal fluid of patients with traumatic brain injury. Free Radic Res 49:1419-1430.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76729629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2468-5577.193148
U. Mateti, P. Prabhakaran, T. Sanal
To assess the utilization patterns of benzodiazepines in psychiatric patients in a tertiary care teaching hospital, a prospective observational study was conducted for a period of 8 months. Drug therapy details in medication chart review and clinical review in patients treated with benzodiazepines was analyzed to measure the utilization pattern of benzodiazepines in terms of defined daily dose (DDD) per 100 bed-days. A total of 160 patients, including 88.8% of males and 11.2% of females, were included in the study. Most of the patients were between the age groups of 30-39 years (33.1%). The most common clinical conditions treated with benzodiazepines were mental and behavioural disorders due to alcohol (65.6%). The majority of patients were prescribed with lorazepam (83.1%). The DDD per 100 bed-days of benzodiazepines were found to be 0.98. The prescribed daily dose and DDD of benzodiazepines were 57.16 ± 30.3 and 89.69 ± 39.16, respectively. The total cost per DDD of benzodiazepines was 28.9 Indian Rupees (INR). Our study results indicate that the most common clinical conditions treated with benzodiazepines were mental and behavioural disorders due to alcohol and the majority of patients were prescribed lorazepam.
{"title":"Utilization patterns of benzodiazepines in psychiatric patients in a tertiary care teaching hospital","authors":"U. Mateti, P. Prabhakaran, T. Sanal","doi":"10.4103/2468-5577.193148","DOIUrl":"https://doi.org/10.4103/2468-5577.193148","url":null,"abstract":"To assess the utilization patterns of benzodiazepines in psychiatric patients in a tertiary care teaching hospital, a prospective observational study was conducted for a period of 8 months. Drug therapy details in medication chart review and clinical review in patients treated with benzodiazepines was analyzed to measure the utilization pattern of benzodiazepines in terms of defined daily dose (DDD) per 100 bed-days. A total of 160 patients, including 88.8% of males and 11.2% of females, were included in the study. Most of the patients were between the age groups of 30-39 years (33.1%). The most common clinical conditions treated with benzodiazepines were mental and behavioural disorders due to alcohol (65.6%). The majority of patients were prescribed with lorazepam (83.1%). The DDD per 100 bed-days of benzodiazepines were found to be 0.98. The prescribed daily dose and DDD of benzodiazepines were 57.16 ± 30.3 and 89.69 ± 39.16, respectively. The total cost per DDD of benzodiazepines was 28.9 Indian Rupees (INR). Our study results indicate that the most common clinical conditions treated with benzodiazepines were mental and behavioural disorders due to alcohol and the majority of patients were prescribed lorazepam.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82270979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Intensive versus nonintensive insulin therapy for hyperglycemia after traumatic brain injury: study protocol for a randomized controlled trial","authors":"Wen-xue Wang, Ai-min Li, Jian-wei Wang, Xin Kang, Guang-hui Fu, Yu-liang Liu","doi":"10.4103/2455-7765.173001","DOIUrl":"https://doi.org/10.4103/2455-7765.173001","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73633231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2468-5577.193143
A. Trevizol, P. Shiozawa, Q. Cordeiro
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.
{"title":"Electroencephalographic changes following trigeminal nerve stimulation for major depressive disorder: study protocol for a randomized sham-controlled trial","authors":"A. Trevizol, P. Shiozawa, Q. Cordeiro","doi":"10.4103/2468-5577.193143","DOIUrl":"https://doi.org/10.4103/2468-5577.193143","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74734162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2455-7765.173008
Jun-yan Feng, L. Shan, B. Wang, F. Jia
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.
{"title":"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","authors":"Jun-yan Feng, L. Shan, B. Wang, F. Jia","doi":"10.4103/2455-7765.173008","DOIUrl":"https://doi.org/10.4103/2455-7765.173008","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77674697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2455-7765.172998
Run-hui Li
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.
{"title":"The optimal time window for the use and dosage of nimodipine for acute massive cerebral infarction: study protocol for a randomized controlled trial","authors":"Run-hui Li","doi":"10.4103/2455-7765.172998","DOIUrl":"https://doi.org/10.4103/2455-7765.172998","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88455250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2455-7765.173000
Chao-liang Tang, Jun Li
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).
{"title":"Postoperative sedation by intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage: study protocol for a randomized parallel-cohort controlled trial","authors":"Chao-liang Tang, Jun Li","doi":"10.4103/2455-7765.173000","DOIUrl":"https://doi.org/10.4103/2455-7765.173000","url":null,"abstract":"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).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81146390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2455-7765.173011
L. Shan, B. Wang, Xiao-lan Hu, F. Jia
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.
{"title":"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","authors":"L. Shan, B. Wang, Xiao-lan Hu, F. Jia","doi":"10.4103/2455-7765.173011","DOIUrl":"https://doi.org/10.4103/2455-7765.173011","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79205746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.4103/2455-7765.173005
Yue Yun, L. Pei
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.
{"title":"Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial","authors":"Yue Yun, L. Pei","doi":"10.4103/2455-7765.173005","DOIUrl":"https://doi.org/10.4103/2455-7765.173005","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84427038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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