Pub Date : 2020-10-01DOI: 10.4103/2542-3932.304946
Uche Akataobi
Background and objectives: Despite the effective role of monosodium glutamate as a food additive, there are claims indicating that monosodium glutamate consumption increases the level of glutamate an excitatory neurotransmitter which can be toxic to the brain in accumulated level. The present study attempted to understand the differential effect of monosodium glutamate on key enzymes of glutamate metabolisms in rat brain exposed either as neonate or adult to monosodium glutamate. Methods: The rat neonates were divided into six groups with seven animals per group and exposed to different concentrations of monosodium glutamate as neonates only (normal saline or monosodium glutamate 4 mg/g), neonate plus adults (monosodium glutamate 5 or 10 mg/g) and adult only (monosodium glutamate 5 or 10 mg/g). Key enzymes of glutamate metabolisms were measured in whole brain homogenates. All experiments were approved by the Faculty of Basic Medical Sciences University of Calabar and ethics committee-04/11/2018. Results: Except neonate plus adult 5 mg/g group, glutamate dehydrogenase and glutamate synthetase activities were significantly higher in administered groups than in the control group (P < 0.05). There was no significant difference in glutamate synthetase activity among monosodium glutamate administered groups (P > 0.05). The glutamate carboxylase activity was significantly higher in all monosodium glutamate administered groups than in the control group (P < 0.05). The brain alanine aminotransferase and aspartate aminotransferase activities of rats in each monosodium glutamate administered group increased in a dose-dependent manner (P < 0.05). Conclusion: Exposure to monosodium glutamate can increase the activities of key enzymes of glutamate metabolism in the brain of neonate and adult rats similarly, which is not determined by age difference.
{"title":"Key enzymes of glutamate metabolisms in the brain of neonatal and adult rats exposed to monosodium glutamate","authors":"Uche Akataobi","doi":"10.4103/2542-3932.304946","DOIUrl":"https://doi.org/10.4103/2542-3932.304946","url":null,"abstract":"Background and objectives: Despite the effective role of monosodium glutamate as a food additive, there are claims indicating that monosodium glutamate consumption increases the level of glutamate an excitatory neurotransmitter which can be toxic to the brain in accumulated level. The present study attempted to understand the differential effect of monosodium glutamate on key enzymes of glutamate metabolisms in rat brain exposed either as neonate or adult to monosodium glutamate. Methods: The rat neonates were divided into six groups with seven animals per group and exposed to different concentrations of monosodium glutamate as neonates only (normal saline or monosodium glutamate 4 mg/g), neonate plus adults (monosodium glutamate 5 or 10 mg/g) and adult only (monosodium glutamate 5 or 10 mg/g). Key enzymes of glutamate metabolisms were measured in whole brain homogenates. All experiments were approved by the Faculty of Basic Medical Sciences University of Calabar and ethics committee-04/11/2018. Results: Except neonate plus adult 5 mg/g group, glutamate dehydrogenase and glutamate synthetase activities were significantly higher in administered groups than in the control group (P < 0.05). There was no significant difference in glutamate synthetase activity among monosodium glutamate administered groups (P > 0.05). The glutamate carboxylase activity was significantly higher in all monosodium glutamate administered groups than in the control group (P < 0.05). The brain alanine aminotransferase and aspartate aminotransferase activities of rats in each monosodium glutamate administered group increased in a dose-dependent manner (P < 0.05). Conclusion: Exposure to monosodium glutamate can increase the activities of key enzymes of glutamate metabolism in the brain of neonate and adult rats similarly, which is not determined by age difference.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"15 1","pages":"51 - 57"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86927909","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 : 2020-10-01DOI: 10.4103/2542-3932.304945
D. Subramanian, Anita Patel, Madathaniyil George, Swapna Sugunanandagopan, S. Krishna, Sujitha Kelu, Jayakrishnan Kalluvirath, A. Madhavi
Background and objectives: Emerging evidences indicate an invariable relationship between gut dysbiosis and neurobehavioral symptoms of autism spectrum disorder. In India, Ayurveda is widely accepted among the complementary and alternative medicine. This study aimed to assess the efficacy of an Ayurveda gut therapy protocol in autism spectrum disorder. Subjects and methods: In this randomized controlled trial, 60 children with autism spectrum disorder admitted to Vaidyaratnam P S Varier Ayurveda College, India will be randomly assigned to intervention and control groups. The intervention group will undergo Ayurveda gut therapy protocol for 30 days and interdisciplinary interventions for 2 months, whereas the control group will undergo only interdisciplinary interventions for 2 months. A final assessment will be done on the 60 th day. Patient recruitment began in July 2018. The primary and secondary outcome measure will be completed in January 2021 and the study will be completed in September 2022. The study was approved by the Institutional Ethical Committee of Vaidyaratnam P S Varier Ayurveda College, India (Proceedings No: IEC/CI/24/17) on May 4, 2017. Protocol version: 1.0. Outcome measures: The expected primary outcome is to assess the quality and quantity of the gut microbes through 16s rRNA sequencing. The secondary outcome expected is the changes in the neurobehavioral symptoms assessed through the Childhood Autism Rating Scale and also changes in the gastrointestinal symptoms assessed through Ayurveda Gut Health Assessment Questionnaire. Discussion: The current protocol discusses the relationship between Autism and gut dysbiosis and its management through Ayurveda, and provides evidence for the rationality of using Ayurveda gut therapy as an alternative therapy for autism spectrum disorder in clinical practice. Trial registration: The study was registered with Clinical Trial Registry of India (registration No. CTRI/2018/05/014017, registered on May 21, 2018).
背景与目的:越来越多的证据表明，肠道生态失调与自闭症谱系障碍的神经行为症状之间存在着不变的关系。在印度，阿育吠陀在补充和替代医学中被广泛接受。本研究旨在评估阿育吠陀肠道治疗方案对自闭症谱系障碍的疗效。对象与方法:本随机对照试验将60名印度瓦耶拉特纳姆阿育吠陀学院(Vaidyaratnam P S Varier Ayurveda College)的自闭症谱系障碍儿童随机分为干预组和对照组。干预组将接受30天的阿育吠陀肠道治疗方案和2个月的跨学科干预，而对照组只接受2个月的跨学科干预。最后的评估将在第60天完成。患者招募于2018年7月开始。主要和次要结果测量将于2021年1月完成，研究将于2022年9月完成。该研究于2017年5月4日获得印度Vaidyaratnam P S Varier Ayurveda学院机构伦理委员会的批准(会议记录号:IEC/CI/24/17)。协议版本:1.0。结果测量:预期的主要结果是通过16s rRNA测序评估肠道微生物的质量和数量。预期的次要结局是通过儿童自闭症评定量表评估的神经行为症状的变化，以及通过阿育吠陀肠道健康评估问卷评估的胃肠道症状的变化。讨论:本协议讨论了自闭症与肠道生态失调的关系，以及通过阿育吠陀疗法对其进行治疗，并为在临床实践中使用阿育吠陀肠道疗法作为自闭症谱系障碍的替代疗法的合理性提供了证据。试验注册:本研究已在印度临床试验注册中心注册(注册号:CTRI/2018/05/014017，于2018年5月21日注册)。
{"title":"Effect of Ayurveda gut therapy protocol in managing dysbiosis of children with autism: study protocol for a randomized controlled trial","authors":"D. Subramanian, Anita Patel, Madathaniyil George, Swapna Sugunanandagopan, S. Krishna, Sujitha Kelu, Jayakrishnan Kalluvirath, A. Madhavi","doi":"10.4103/2542-3932.304945","DOIUrl":"https://doi.org/10.4103/2542-3932.304945","url":null,"abstract":"Background and objectives: Emerging evidences indicate an invariable relationship between gut dysbiosis and neurobehavioral symptoms of autism spectrum disorder. In India, Ayurveda is widely accepted among the complementary and alternative medicine. This study aimed to assess the efficacy of an Ayurveda gut therapy protocol in autism spectrum disorder. Subjects and methods: In this randomized controlled trial, 60 children with autism spectrum disorder admitted to Vaidyaratnam P S Varier Ayurveda College, India will be randomly assigned to intervention and control groups. The intervention group will undergo Ayurveda gut therapy protocol for 30 days and interdisciplinary interventions for 2 months, whereas the control group will undergo only interdisciplinary interventions for 2 months. A final assessment will be done on the 60 th day. Patient recruitment began in July 2018. The primary and secondary outcome measure will be completed in January 2021 and the study will be completed in September 2022. The study was approved by the Institutional Ethical Committee of Vaidyaratnam P S Varier Ayurveda College, India (Proceedings No: IEC/CI/24/17) on May 4, 2017. Protocol version: 1.0. Outcome measures: The expected primary outcome is to assess the quality and quantity of the gut microbes through 16s rRNA sequencing. The secondary outcome expected is the changes in the neurobehavioral symptoms assessed through the Childhood Autism Rating Scale and also changes in the gastrointestinal symptoms assessed through Ayurveda Gut Health Assessment Questionnaire. Discussion: The current protocol discusses the relationship between Autism and gut dysbiosis and its management through Ayurveda, and provides evidence for the rationality of using Ayurveda gut therapy as an alternative therapy for autism spectrum disorder in clinical practice. Trial registration: The study was registered with Clinical Trial Registry of India (registration No. CTRI/2018/05/014017, registered on May 21, 2018).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"33 1","pages":"58 - 64"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82344122","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 : 2020-10-01DOI: 10.4103/2542-3932.304944
Alireza Rashtbari, Hossein Malekizadeh, O. Saed
Background and objectives: Worry as a main symptom of generalized anxiety disorder is a chain of repetitive and uncontrollable thoughts about possible negative events in the future. The Penn State Worry Questionnaire is one of the most widely used measures for assessing pathological worry. The purpose of the present study was to investigate the psychometric properties of the abbreviated version of the Penn State Worry Questionnaire-Abbreviated (PSWQ-A) and to compare it with the original version of the Penn State Worry Questionnaire (PSWQ) in a nonclinical sample. Participants and methods: The present study is a cross-sectional psychometric study. The statistical population of this study consisted of all students studying at Zanjan University of Medical Sciences (n = 3500) from January to October 2018. A sample of 350 people was selected for the study. Research measures were the PSWQ-A, PSWQ, and the Generalized Anxiety Disorder 7-item (GAD-7) Scale. The present study was carried out after approval of Social Determinants of Health Research Center of Zanjan University of Medical Science with the project code of A-12-924-5 on October 7, 2017. The project was also approved by the Ethics Committee of Zanjan University of Medical Sciences on October 17, 2017 and the approval ID was IR.ZUMS.REC.1396.187. Results: Exploratory factor analysis, scree plot, and parallel analysis supported the single factor structure PSWQ-A. The total variance explained by the single-factor model of PSWQ-A was higher (53.1% versus 49.1%). Generally, fit indices for the PSWQ-A was better fitted than the PSWQ. Both measures had acceptable convergent validity (r=0.52 for both questionnaires) and satisfactory internal consistency (α=0.87 for both questionnaires). Conclusion: PSWQ-A has better psychometric properties compared to PSWQ, and it can be used for faster and more accurate assessment of worry in psychological studies and therapeutic settings.
{"title":"Comparison of factor structure and psychometric properties of original and abbreviated version of the Penn State Worry Questionnaire in a nonclinical sample: a cross-sectional psychometric study","authors":"Alireza Rashtbari, Hossein Malekizadeh, O. Saed","doi":"10.4103/2542-3932.304944","DOIUrl":"https://doi.org/10.4103/2542-3932.304944","url":null,"abstract":"Background and objectives: Worry as a main symptom of generalized anxiety disorder is a chain of repetitive and uncontrollable thoughts about possible negative events in the future. The Penn State Worry Questionnaire is one of the most widely used measures for assessing pathological worry. The purpose of the present study was to investigate the psychometric properties of the abbreviated version of the Penn State Worry Questionnaire-Abbreviated (PSWQ-A) and to compare it with the original version of the Penn State Worry Questionnaire (PSWQ) in a nonclinical sample. Participants and methods: The present study is a cross-sectional psychometric study. The statistical population of this study consisted of all students studying at Zanjan University of Medical Sciences (n = 3500) from January to October 2018. A sample of 350 people was selected for the study. Research measures were the PSWQ-A, PSWQ, and the Generalized Anxiety Disorder 7-item (GAD-7) Scale. The present study was carried out after approval of Social Determinants of Health Research Center of Zanjan University of Medical Science with the project code of A-12-924-5 on October 7, 2017. The project was also approved by the Ethics Committee of Zanjan University of Medical Sciences on October 17, 2017 and the approval ID was IR.ZUMS.REC.1396.187. Results: Exploratory factor analysis, scree plot, and parallel analysis supported the single factor structure PSWQ-A. The total variance explained by the single-factor model of PSWQ-A was higher (53.1% versus 49.1%). Generally, fit indices for the PSWQ-A was better fitted than the PSWQ. Both measures had acceptable convergent validity (r=0.52 for both questionnaires) and satisfactory internal consistency (α=0.87 for both questionnaires). Conclusion: PSWQ-A has better psychometric properties compared to PSWQ, and it can be used for faster and more accurate assessment of worry in psychological studies and therapeutic settings.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"13 1","pages":"43 - 50"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89045515","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 : 2020-07-01DOI: 10.4103/2542-3932.295802
O. Saed, S. Khakpoor
Anxiety sensitivity means fear of anxiety-related sensations which is one of the important factors in the development and maintenance of substance-related disorders. Studies support the underlying, mediating, and moderating role of this construct in the etiology of substancerelated disorders. This review suggests that anxiety sensitivity can play a role in this group of disorders in different ways, such as fear of body sensations, fear of cognitive dyscontrol, and fear of socially observable anxiety symptoms. Finally, high anxiety sensitivity can interfere with the treatment of substance-related disorders as an underlying vulnerability and increase the likelihood of relapse in this group of people.
{"title":"Anxiety sensitivity and substance-related disorders: a narrative review","authors":"O. Saed, S. Khakpoor","doi":"10.4103/2542-3932.295802","DOIUrl":"https://doi.org/10.4103/2542-3932.295802","url":null,"abstract":"Anxiety sensitivity means fear of anxiety-related sensations which is one of the important factors in the development and maintenance of substance-related disorders. Studies support the underlying, mediating, and moderating role of this construct in the etiology of substancerelated disorders. This review suggests that anxiety sensitivity can play a role in this group of disorders in different ways, such as fear of body sensations, fear of cognitive dyscontrol, and fear of socially observable anxiety symptoms. Finally, high anxiety sensitivity can interfere with the treatment of substance-related disorders as an underlying vulnerability and increase the likelihood of relapse in this group of people.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"34 1","pages":"37 - 41"},"PeriodicalIF":0.0,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91310194","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 : 2020-07-01DOI: 10.4103/2542-3932.295803
R. Kumari, B. Nath
{"title":"Is sample size calculation only about numbers?","authors":"R. Kumari, B. Nath","doi":"10.4103/2542-3932.295803","DOIUrl":"https://doi.org/10.4103/2542-3932.295803","url":null,"abstract":"","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"7 1","pages":"42 - 42"},"PeriodicalIF":0.0,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81966477","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 : 2020-04-01DOI: 10.4103/2542-3932.285359
Background and objective: Epilepsy is a refractory disease of the nervous system. This article aimed to analyze the global trend of epilepsy research and the contribution of China to this research. Methods: This paper used “epilepsy, seizure, status epilepticus, SUDEP” to retrieve epilepsy-related articles indexed in the Web of Science from 2011 to 2020, classified and analyzed the global epilepsy-related articles. Results: This paper analyzed 65,270 articles on epilepsy research, showing that Epilepsy Behavior and Epilepsy Research were journals with the largest number of articles concerning epilepsy research in the world and China, respectively. The number of published epilepsy-related articles accounts for 5.43% of the global published articles and 3.29% of the published articles in China. The United States Department of Health Human Services and the National Institutes of Health jointly sponsored 15,713 of these articles, ranking first worldwide in the published epilepsy-related articles. Among 5206 articles published in China, 2696 articles (46.42%) were supported by the National Natural Science Foundation of China. Conclusion: This study has reference significance for researchers in this field to understand the 10-year overview of epilepsy researches and formulate future research directions.
背景与目的:癫痫是一种难治性神经系统疾病。本文旨在分析全球癫痫研究的趋势以及中国在这方面的贡献。方法:采用“癫痫、发作、癫痫持续状态、癫痫猝死”检索Web of Science 2011 - 2020年收录的癫痫相关文章，对全球癫痫相关文章进行分类分析。结果:共分析癫痫研究论文65270篇，《癫痫行为》和《癫痫研究》分别是国际和国内癫痫研究论文最多的期刊。癫痫病相关文章发表数占全球发表数的5.43%，占国内发表数的3.29%。美国卫生与公众服务部和国立卫生研究院共同赞助了其中15 713篇文章，在发表的与癫痫有关的文章中排名世界第一。在国内发表的5206篇论文中，国家自然科学基金资助论文2696篇，占46.42%。结论:本研究对本领域研究人员了解癫痫研究10年概况，制定未来研究方向具有参考意义。
{"title":"Epilepsy-related researches in Web of Science from 2011 to 2020: a bibliometric analysis","authors":"","doi":"10.4103/2542-3932.285359","DOIUrl":"https://doi.org/10.4103/2542-3932.285359","url":null,"abstract":"Background and objective: Epilepsy is a refractory disease of the nervous system. This article aimed to analyze the global trend of epilepsy research and the contribution of China to this research. Methods: This paper used “epilepsy, seizure, status epilepticus, SUDEP” to retrieve epilepsy-related articles indexed in the Web of Science from 2011 to 2020, classified and analyzed the global epilepsy-related articles. Results: This paper analyzed 65,270 articles on epilepsy research, showing that Epilepsy Behavior and Epilepsy Research were journals with the largest number of articles concerning epilepsy research in the world and China, respectively. The number of published epilepsy-related articles accounts for 5.43% of the global published articles and 3.29% of the published articles in China. The United States Department of Health Human Services and the National Institutes of Health jointly sponsored 15,713 of these articles, ranking first worldwide in the published epilepsy-related articles. Among 5206 articles published in China, 2696 articles (46.42%) were supported by the National Natural Science Foundation of China. Conclusion: This study has reference significance for researchers in this field to understand the 10-year overview of epilepsy researches and formulate future research directions.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"136 1","pages":"32 - 36"},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76735115","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 : 2020-04-01DOI: 10.4103/2542-3932.285358
Kangguang Lin, Wan Zeng, Xiong Huang
Background and objective: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive nerve stimulation technique that has the potential to improve cognitive function. However, there have been few randomized controlled trials (RCTs) that evaluated the effectiveness of rTMS on cognitive function and the relapse in patients with bipolar disorder. Participants and methods: This double-blind parallel RCT will be conducted at The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China. A total of 74 bipolar disorder patients will be recruited and randomly assigned to a trial group (n = 37) and control group (n = 37). Repetitive transcranial magnetic stimulation and sham repetitive transcranial magnetic stimulation will be applied over the left dorsolateral prefrontal cortex in the trial group and control group, respectively. This trial was designed on March 2, 2017 and was approved by the Ethics Committee of The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China on April 25, 2017 (approval No. 2017022). Patient recruitment began on July 10, 2017 and will be finished in December 2020. The trial will be completed in December 2021. The protocol version is 1.0. Outcome measures: The primary outcome measure will be the difference between MATRICS Consensus Cognitive Battery scores at post-intervention and at baseline. The secondary outcome measures will be relapse of depressive and/or hypo/mania episode at a one-year follow-up. Discussion: This clinical trial will provide data regarding effectiveness in long-term cognitive function and relapse of mood episode following repetitive transcranial magnetic stimulation in patients with bipolar disorder. Trial registration: This trial had been registered in the ClinicalTrials.gov (identifier: NCT03207048) on July 2, 2017.
{"title":"Effects of repetitive transcranial magnetic stimulation on cognitive function and recurrence of symptoms in individuals with bipolar disorder: a double-blind parallel randomized controlled trial","authors":"Kangguang Lin, Wan Zeng, Xiong Huang","doi":"10.4103/2542-3932.285358","DOIUrl":"https://doi.org/10.4103/2542-3932.285358","url":null,"abstract":"Background and objective: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive nerve stimulation technique that has the potential to improve cognitive function. However, there have been few randomized controlled trials (RCTs) that evaluated the effectiveness of rTMS on cognitive function and the relapse in patients with bipolar disorder. Participants and methods: This double-blind parallel RCT will be conducted at The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China. A total of 74 bipolar disorder patients will be recruited and randomly assigned to a trial group (n = 37) and control group (n = 37). Repetitive transcranial magnetic stimulation and sham repetitive transcranial magnetic stimulation will be applied over the left dorsolateral prefrontal cortex in the trial group and control group, respectively. This trial was designed on March 2, 2017 and was approved by the Ethics Committee of The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China on April 25, 2017 (approval No. 2017022). Patient recruitment began on July 10, 2017 and will be finished in December 2020. The trial will be completed in December 2021. The protocol version is 1.0. Outcome measures: The primary outcome measure will be the difference between MATRICS Consensus Cognitive Battery scores at post-intervention and at baseline. The secondary outcome measures will be relapse of depressive and/or hypo/mania episode at a one-year follow-up. Discussion: This clinical trial will provide data regarding effectiveness in long-term cognitive function and relapse of mood episode following repetitive transcranial magnetic stimulation in patients with bipolar disorder. Trial registration: This trial had been registered in the ClinicalTrials.gov (identifier: NCT03207048) on July 2, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"56 1","pages":"27 - 31"},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81047319","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 : 2020-01-01DOI: 10.4103/2542-3932.280611
G. Kaner, E. Bellikci-Koyu, Nilgun Seremet-Kurklu, Kubra Tel-Adiguzel
Background and objective: Obesity has been widely regarded as a public health concern because of its adverse impact on health. The aim of this study is to examine the relationship of body mass index, abdominal obesity, and metabolic parameters with depression among reproductive-age women. Subjects and methods: Two hundred and seventy-one women who admitted to the Endocrine and Diet Polyclinic of İzmir Bozyaka Training and Research Hospital, Turkey were included. Sociodemographic characteristics were gathered using a data collection form. Biochemical findings were examined in fasting blood samples and anthropometric measurements were taken. Depressive symptoms of participants were measured with Beck Depression Inventory. This study was performed with the permission from Chief Physician of Izmir Bozyaka Training and Research Hospital (No. 4.35.94.02-003) and approval from the Senate Ethics Committee of Hacettepe University Faculty of Medicine (Decision No. 431-1305). Results: Mean score of participants for Beck Depression Inventory was 17.8 ± 11.8. Body weight, body mass index and waist circumference were higher in the group with high level of depressive symptoms than in the group with low level of depressive symptoms (P < 0.05). Fasting blood glucose, fasting insulin, Homeostasis Model Assessment-Insulin Resistance value, triglyceride and low-density lipoprotein cholesterol were also higher in the group with high level of depressive symptoms than in the group with low level of depressive symptoms; but only HOMA-IR and triglyceride differences were statistically significant (P < 0.05). Being overweight or obese was associated with increased risk of high level of depressive symptoms (OR = 4.853, 95% CI: 2.646–8.903). Although the ratio of having high level of depressive symptoms was higher in women with abdominal obesity (50.3%) compared to women without abdominal obesity (39.5%), the difference was not statistically significant (P = 0.078). Conclusion: In this study, it was determined that the level of depressive symptoms was higher in overweight or obese women than women with normal body weight. It may be useful to monitor women who apply for weight control in terms of risk of depression.
{"title":"Relationship of body mass index, abdominal obesity, and metabolic parameters with depression among reproductive-age women","authors":"G. Kaner, E. Bellikci-Koyu, Nilgun Seremet-Kurklu, Kubra Tel-Adiguzel","doi":"10.4103/2542-3932.280611","DOIUrl":"https://doi.org/10.4103/2542-3932.280611","url":null,"abstract":"Background and objective: Obesity has been widely regarded as a public health concern because of its adverse impact on health. The aim of this study is to examine the relationship of body mass index, abdominal obesity, and metabolic parameters with depression among reproductive-age women. Subjects and methods: Two hundred and seventy-one women who admitted to the Endocrine and Diet Polyclinic of İzmir Bozyaka Training and Research Hospital, Turkey were included. Sociodemographic characteristics were gathered using a data collection form. Biochemical findings were examined in fasting blood samples and anthropometric measurements were taken. Depressive symptoms of participants were measured with Beck Depression Inventory. This study was performed with the permission from Chief Physician of Izmir Bozyaka Training and Research Hospital (No. 4.35.94.02-003) and approval from the Senate Ethics Committee of Hacettepe University Faculty of Medicine (Decision No. 431-1305). Results: Mean score of participants for Beck Depression Inventory was 17.8 ± 11.8. Body weight, body mass index and waist circumference were higher in the group with high level of depressive symptoms than in the group with low level of depressive symptoms (P < 0.05). Fasting blood glucose, fasting insulin, Homeostasis Model Assessment-Insulin Resistance value, triglyceride and low-density lipoprotein cholesterol were also higher in the group with high level of depressive symptoms than in the group with low level of depressive symptoms; but only HOMA-IR and triglyceride differences were statistically significant (P < 0.05). Being overweight or obese was associated with increased risk of high level of depressive symptoms (OR = 4.853, 95% CI: 2.646–8.903). Although the ratio of having high level of depressive symptoms was higher in women with abdominal obesity (50.3%) compared to women without abdominal obesity (39.5%), the difference was not statistically significant (P = 0.078). Conclusion: In this study, it was determined that the level of depressive symptoms was higher in overweight or obese women than women with normal body weight. It may be useful to monitor women who apply for weight control in terms of risk of depression.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"35 1","pages":"1 - 5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86648406","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 : 2020-01-01DOI: 10.4103/2542-3932.280613
Yong-Pan Liu, Xiaolei Gong
Background and objective: The inhalational anesthetic sevoflurane is often used in craniocerebral surgery for its advantages of quick onset, stable circulation, high safety, and few adverse reactions. However, it can also lead to abnormal blood pressure and heart rate, as well as restlessness and pain. Therefore, an auxiliary anesthetic is needed to help reduce adverse reactions. Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist that has anti-anxiety, hypnotic, analgesic, sedative, and sympatholytic properties. Dexmedetomidine has been shown to reduce restlessness after sevoflurane inhalation anesthesia and minimize perioperative hemodynamic fluctuation. However, its application in craniocerebral surgery should be validated. The purpose of this study was to investigate the efficacy of dexmedetomidine in craniocerebral surgery under sevoflurane inhalation anesthesia. Subjects and methods: The prospective, single-center, randomized, controlled study will be performed in Taihe Hospital (Shiyan, China). The 1308 patients to be included in this study will be randomly divided into a trial group and control group (n = 654 patients per group) based on a table of random permutations. In both groups, sevoflurane will be used for induction of anesthesia for craniocerebral surgery. In the trial group, 1 μg/kg dexmedetomidine will be injected intravenously for 10 minutes commencing 15 minutes before anesthesia induction, and then continuously pumped at 0.3 μg/kg per hour until 30 minutes before surgery. In the control group, 0.9% sodium chloride injection will be administered in the same way and at the same injection rate. This trial was approved by the Ethics Review Committee of Taihe Hospital on December 8, 2015 (approval No. 2015GJJ-087). Protocol version: 1.0. Participants will not be blind to the study protocol or procedure, and will provide signed informed consent. Results: The primary outcome of this study is recovery time. Secondary outcomes of this study include anesthesia, recovery, and adverse events, as well as vital signs, stress index, and cerebral metabolic rate of oxygen consumption at different time points (before and after administration of the loading dose of dexmedetomidine, during anesthesia induction, at the beginning of craniocerebral surgery, during craniocerebral surgery, at the end of craniocerebral surgery, and at the time of recovery). A pilot study involving 190 patients who underwent craniocerebral surgery was performed between March 2016 and February 2017. These 190 patients randomly received either sevoflurane anesthesia (n = 95, control group) or dexmedetomidine and sevoflurane anesthesia (n = 95, trial group). Results of the pilot group showed that anesthesia time, intraoperative bleeding volume, intraoperative infusion volume, recovery time, and extubation time were similar between trial and control groups (P > 0.05). However, compared with the control group, the administered dosages of vasoacti
{"title":"Effects of dexmedetomidine on perioperative brain protection in patients undergoing craniocerebral surgery under inhalation anesthesia with sevoflurane: a randomized controlled study","authors":"Yong-Pan Liu, Xiaolei Gong","doi":"10.4103/2542-3932.280613","DOIUrl":"https://doi.org/10.4103/2542-3932.280613","url":null,"abstract":"Background and objective: The inhalational anesthetic sevoflurane is often used in craniocerebral surgery for its advantages of quick onset, stable circulation, high safety, and few adverse reactions. However, it can also lead to abnormal blood pressure and heart rate, as well as restlessness and pain. Therefore, an auxiliary anesthetic is needed to help reduce adverse reactions. Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist that has anti-anxiety, hypnotic, analgesic, sedative, and sympatholytic properties. Dexmedetomidine has been shown to reduce restlessness after sevoflurane inhalation anesthesia and minimize perioperative hemodynamic fluctuation. However, its application in craniocerebral surgery should be validated. The purpose of this study was to investigate the efficacy of dexmedetomidine in craniocerebral surgery under sevoflurane inhalation anesthesia. Subjects and methods: The prospective, single-center, randomized, controlled study will be performed in Taihe Hospital (Shiyan, China). The 1308 patients to be included in this study will be randomly divided into a trial group and control group (n = 654 patients per group) based on a table of random permutations. In both groups, sevoflurane will be used for induction of anesthesia for craniocerebral surgery. In the trial group, 1 μg/kg dexmedetomidine will be injected intravenously for 10 minutes commencing 15 minutes before anesthesia induction, and then continuously pumped at 0.3 μg/kg per hour until 30 minutes before surgery. In the control group, 0.9% sodium chloride injection will be administered in the same way and at the same injection rate. This trial was approved by the Ethics Review Committee of Taihe Hospital on December 8, 2015 (approval No. 2015GJJ-087). Protocol version: 1.0. Participants will not be blind to the study protocol or procedure, and will provide signed informed consent. Results: The primary outcome of this study is recovery time. Secondary outcomes of this study include anesthesia, recovery, and adverse events, as well as vital signs, stress index, and cerebral metabolic rate of oxygen consumption at different time points (before and after administration of the loading dose of dexmedetomidine, during anesthesia induction, at the beginning of craniocerebral surgery, during craniocerebral surgery, at the end of craniocerebral surgery, and at the time of recovery). A pilot study involving 190 patients who underwent craniocerebral surgery was performed between March 2016 and February 2017. These 190 patients randomly received either sevoflurane anesthesia (n = 95, control group) or dexmedetomidine and sevoflurane anesthesia (n = 95, trial group). Results of the pilot group showed that anesthesia time, intraoperative bleeding volume, intraoperative infusion volume, recovery time, and extubation time were similar between trial and control groups (P > 0.05). However, compared with the control group, the administered dosages of vasoacti","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"8 1","pages":"12 - 20"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91107059","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 : 2020-01-01DOI: 10.4103/2542-3932.280612
Kangguang Lin
Background and objectives: Exercise can be used to treat mild to moderate depression. Although previous studies have shown that aerobic exercise may have a therapeutic effect on patients with bipolar disorder, no studies have reported on the effect of aerobic exercise on cognitive function in this patient group. This clinical trial will explore the effects of aerobic exercise on cognitive function in patients with bipolar disorder. Participants and methods: This parallel randomized controlled clinical trial will be conducted at The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China. A total of 210 bipolar disorder patients will be recruited and randomly assigned to an aerobic exercise group or a control group (n = 105). In the aerobic exercise group, the patients will perform 30 minutes of bicycling, 4 days per week, for 30 consecutive days. The exercise intensity will be 50–70% of the maximum heart rate (220–age). In the control group, the patients will perform recreational activities with a normal intensity, such as making handicrafts, reading, singing, and walking, for 30 minutes, 4 days per week, for 30 consecutive days. This trial was designed in June 2017 and was approved by the Ethics Committee of the Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China on July 24, 2017 (approval No. 2017026). Patient recruitment began on December 1, 2017 and will be finished in November 2020. This trial will be complete in December 2020. Protocol version (1.0). Outcome measures: The primary outcome measure will be the improvement in the MATRICS Consensus Cognitive Battery (MCCB) score 12 months after the exercise intervention. The secondary outcome measures will be the MCCB score at baseline and at a 3-month follow-up assessment, the recurrence rate at 12 months, depressive and manic symptoms at baseline, 4-week, 4-month, and 12-month follow-up assessments, and the incidence of adverse events within 12 months of the follow-up assessment. Discussion: This clinical trial will provide evidence regarding the effect of aerobic exercise on cognitive impairment in patients with bipolar disorder. Trial registration: This trial had been registered in the ClinicalTrials.gov (identifier: NCT03353337) on November 27, 2017.
{"title":"Effects of aerobic exercise on cognitive function in patients with bipolar disorder: a parallel randomized controlled clinical trial","authors":"Kangguang Lin","doi":"10.4103/2542-3932.280612","DOIUrl":"https://doi.org/10.4103/2542-3932.280612","url":null,"abstract":"Background and objectives: Exercise can be used to treat mild to moderate depression. Although previous studies have shown that aerobic exercise may have a therapeutic effect on patients with bipolar disorder, no studies have reported on the effect of aerobic exercise on cognitive function in this patient group. This clinical trial will explore the effects of aerobic exercise on cognitive function in patients with bipolar disorder. Participants and methods: This parallel randomized controlled clinical trial will be conducted at The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China. A total of 210 bipolar disorder patients will be recruited and randomly assigned to an aerobic exercise group or a control group (n = 105). In the aerobic exercise group, the patients will perform 30 minutes of bicycling, 4 days per week, for 30 consecutive days. The exercise intensity will be 50–70% of the maximum heart rate (220–age). In the control group, the patients will perform recreational activities with a normal intensity, such as making handicrafts, reading, singing, and walking, for 30 minutes, 4 days per week, for 30 consecutive days. This trial was designed in June 2017 and was approved by the Ethics Committee of the Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China on July 24, 2017 (approval No. 2017026). Patient recruitment began on December 1, 2017 and will be finished in November 2020. This trial will be complete in December 2020. Protocol version (1.0). Outcome measures: The primary outcome measure will be the improvement in the MATRICS Consensus Cognitive Battery (MCCB) score 12 months after the exercise intervention. The secondary outcome measures will be the MCCB score at baseline and at a 3-month follow-up assessment, the recurrence rate at 12 months, depressive and manic symptoms at baseline, 4-week, 4-month, and 12-month follow-up assessments, and the incidence of adverse events within 12 months of the follow-up assessment. Discussion: This clinical trial will provide evidence regarding the effect of aerobic exercise on cognitive impairment in patients with bipolar disorder. Trial registration: This trial had been registered in the ClinicalTrials.gov (identifier: NCT03353337) on November 27, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"89 1","pages":"6 - 11"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74868968","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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