Pub Date : 2018-01-01DOI: 10.4103/2542-3932.226186
Jingjing Zhou, Jian Yang, Xiao-hua Zhang, Gang Wang
Background and objectives: Patients with treatment-resistant depression (TRD) show no improvement after treatment with a series of drugs. Previous reports have described positive effects of vagus nerve stimulation (VNS) on the emotional states of patients with epilepsy. VNS for TRD has not been explored in China. We will investigate the efficacy and safety of VNS for the treatment of TRD in a Chinese cohort. Design: A pilot self-controlled trial. Methods: The study population will comprise 10 consecutive patients with TRD admitted to Beijing Anding Hospital at Capital Medical University in Beijing, China. The patients will receive routine treatment supplemented with VNS starting at 2 weeks after surgery. Follow-up evaluations will be performed at 1, 2, 3, 6, and 12 months of nerve stimulation. Outcome measures: The primary outcome measure will be the change in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to 12 months of nerve stimulation. The secondary outcome measures will include the proportion of patients who achieve ≥ 50% reduction from baseline in the HAMD-17 total score, complete remission rate, and the Quick Inventory of Depression Symptomatology-Self Report, 7-item Generalized Anxiety Disorder Scale, Global Assessment of Function, Clinical Global Impression-severity, Clinical Global Impression-improvement, Hamilton Rating Scale for Anxiety, Young Mania Rating Scale, Patient Health Questionaire-15, Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Perceived Deficits Questionnaire-Depression, Frequency, Intensity and Burden of Side Effects Rating, and Columbia-Suicide Severity Rating Scale scores. Discussion: The trial will provide objective data on the potential of the clinical implementation of VNS as a treatment for TRD in China. Ethics and dissemination: This study protocol was approved by the Institution Review Board of Beijing Anding Hospital of Capital Medical University in China (approval No. 201775FS-2) at October 2017. Design of the study was finished in August 2017, participant recruitment was started at December 2017, and data analysis will be completed until December 2021. The results of the study will be disseminated through presentations at peer-reviewed publications. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR-ONC-174013430 (version 2.0) in November 2017.
{"title":"Vagus nerve stimulation for treatment-resistant depression: protocol for a pilot self-controlled trial","authors":"Jingjing Zhou, Jian Yang, Xiao-hua Zhang, Gang Wang","doi":"10.4103/2542-3932.226186","DOIUrl":"https://doi.org/10.4103/2542-3932.226186","url":null,"abstract":"Background and objectives: Patients with treatment-resistant depression (TRD) show no improvement after treatment with a series of drugs. Previous reports have described positive effects of vagus nerve stimulation (VNS) on the emotional states of patients with epilepsy. VNS for TRD has not been explored in China. We will investigate the efficacy and safety of VNS for the treatment of TRD in a Chinese cohort. Design: A pilot self-controlled trial. Methods: The study population will comprise 10 consecutive patients with TRD admitted to Beijing Anding Hospital at Capital Medical University in Beijing, China. The patients will receive routine treatment supplemented with VNS starting at 2 weeks after surgery. Follow-up evaluations will be performed at 1, 2, 3, 6, and 12 months of nerve stimulation. Outcome measures: The primary outcome measure will be the change in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to 12 months of nerve stimulation. The secondary outcome measures will include the proportion of patients who achieve ≥ 50% reduction from baseline in the HAMD-17 total score, complete remission rate, and the Quick Inventory of Depression Symptomatology-Self Report, 7-item Generalized Anxiety Disorder Scale, Global Assessment of Function, Clinical Global Impression-severity, Clinical Global Impression-improvement, Hamilton Rating Scale for Anxiety, Young Mania Rating Scale, Patient Health Questionaire-15, Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Perceived Deficits Questionnaire-Depression, Frequency, Intensity and Burden of Side Effects Rating, and Columbia-Suicide Severity Rating Scale scores. Discussion: The trial will provide objective data on the potential of the clinical implementation of VNS as a treatment for TRD in China. Ethics and dissemination: This study protocol was approved by the Institution Review Board of Beijing Anding Hospital of Capital Medical University in China (approval No. 201775FS-2) at October 2017. Design of the study was finished in August 2017, participant recruitment was started at December 2017, and data analysis will be completed until December 2021. The results of the study will be disseminated through presentations at peer-reviewed publications. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR-ONC-174013430 (version 2.0) in November 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90621161","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 : 2018-01-01DOI: 10.4103/2542-3932.232081
Hong-Mei Ding, Xiaolong Wang, Yingfeng Mu, Jinmei Li, D. Geng, Tie Xu, M. Wan, Xiao-yun Liu
Background and objectives: As degenerative changes in dopaminergic neurons occur only in the substantia nigra and striatum of patients with Parkinson's disease (PD), cellular therapy is suitable for this condition. However, previous clinical studies using stem cells for treatment of PD have short follow-ups. Thus, studies with longer follow-ups are required to further investigate the efficacy of stem cell-based therapy. Design: A non-randomized controlled trial. Methods: Ninety eligible PD patients will be recruited from the Department of Neurology at the Affiliated Hospital of Xuzhou Medical University, China. These patients will be assigned to three groups according to each patient's or their legal guardians’ wishes (n = 30 per group). In the control group, 12-week routine drug treatment will be performed. In intrathecal administration and intravenous administration groups, intrathecal administration of autologous neural stem cells (NSCs) into the subarachnoid space or intravenous administration of autologous NSCs will be performed once a week for 4 successive weeks in addition to the 12-week routine drug treatment. Outcome measures: The primary outcome measure is symptom improvement rate at 36 months post-treatment. Secondary outcome measures are nigrostriatal dopamine content, α-synuclein content in blood and cerebrospinal fluid, Barthel index, and safety indicators. Discussion: This study will be performed to demonstrate efficacy of autologous NSC transplantation as a prospective treatment for PD and investigate differences between intrathecal and intravenous transplantation routes, thus providing objective quantitative evidence for clinical applications. Ethics and dissemination: This study was designed in July 2017. Ethics approval from Medical Ethics Committee of the Affiliated Hospital of Xuzhou Medical University of China was achieved on December 22, 2017 (approval No. XYFY2017-KL052-01). The study protocol was registered on December 25, 2017. Patient recruitment began in January 2018 and will end in January 2019. Each patient will be followed up for 36 months. Follow-ups will be completed in January 2022. Data analysis will be performed in July 2022. Results will be disseminated by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17014141). Protocol version (1.0).
{"title":"Transplantation of autologous neural stem cells for treatment of Parkinson's disease: study protocol for a non-randomized controlled trial","authors":"Hong-Mei Ding, Xiaolong Wang, Yingfeng Mu, Jinmei Li, D. Geng, Tie Xu, M. Wan, Xiao-yun Liu","doi":"10.4103/2542-3932.232081","DOIUrl":"https://doi.org/10.4103/2542-3932.232081","url":null,"abstract":"Background and objectives: As degenerative changes in dopaminergic neurons occur only in the substantia nigra and striatum of patients with Parkinson's disease (PD), cellular therapy is suitable for this condition. However, previous clinical studies using stem cells for treatment of PD have short follow-ups. Thus, studies with longer follow-ups are required to further investigate the efficacy of stem cell-based therapy. Design: A non-randomized controlled trial. Methods: Ninety eligible PD patients will be recruited from the Department of Neurology at the Affiliated Hospital of Xuzhou Medical University, China. These patients will be assigned to three groups according to each patient's or their legal guardians’ wishes (n = 30 per group). In the control group, 12-week routine drug treatment will be performed. In intrathecal administration and intravenous administration groups, intrathecal administration of autologous neural stem cells (NSCs) into the subarachnoid space or intravenous administration of autologous NSCs will be performed once a week for 4 successive weeks in addition to the 12-week routine drug treatment. Outcome measures: The primary outcome measure is symptom improvement rate at 36 months post-treatment. Secondary outcome measures are nigrostriatal dopamine content, α-synuclein content in blood and cerebrospinal fluid, Barthel index, and safety indicators. Discussion: This study will be performed to demonstrate efficacy of autologous NSC transplantation as a prospective treatment for PD and investigate differences between intrathecal and intravenous transplantation routes, thus providing objective quantitative evidence for clinical applications. Ethics and dissemination: This study was designed in July 2017. Ethics approval from Medical Ethics Committee of the Affiliated Hospital of Xuzhou Medical University of China was achieved on December 22, 2017 (approval No. XYFY2017-KL052-01). The study protocol was registered on December 25, 2017. Patient recruitment began in January 2018 and will end in January 2019. Each patient will be followed up for 36 months. Follow-ups will be completed in January 2022. Data analysis will be performed in July 2022. Results will be disseminated by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17014141). Protocol version (1.0).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85488603","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 : 2018-01-01DOI: 10.4103/2542-3932.226193
Chun-Liang Li, Qiang Guo, Feng Qin, Wenqi Yan, Haitao Zhu, Kai Wang
Background and objectives: Senile degenerative lumbar spinal stenosis typically manifests clinically as lower back and leg pain caused by compression of the nerve root. Conventional total laminectomy for degenerative lumbar spinal stenosis can quickly alleviate a patient's symptoms, but produces an unsatisfactory therapeutic effect because of spinal instability caused by degenerative spondylolisthesis, and also has many adverse reactions. The purpose of this study is to investigate whether total laminectomy combined with lumbar pedicle screw fixation for treatment of senile degenerative lumbar spinal stenosis can effectively reduce lower back and leg pain caused by compression of the nerve root, increase lumbar spine stability, and reduce adverse reactions. Design: A prospective, single-center, self-control, interventional trial. Methods: One hundred and sixty older adult patients with degenerative lumbar spinal stenosis who will receive treatment at the Department of Orthopedics, Qinghai Provincial People's Hospital, China will be included in this study. All patients will undergo total laminectomy combined with lumbar pedicle screw fixation, with follow-up at 3, 6, 9, and 12 months post-surgery. Outcome measures and preliminary results: The primary outcome measure of this study is recovery rate in Japanese Orthopedic Society (JOA) score at 12 months post-surgery, which is used to evaluate improvements in patients lower back and leg pain. Secondary outcome measures of this study include changes in JOA score, spinal canal diameter, lumbar spine morphology displayed on computed tomography images, and incidence of adverse events post-surgery. Results of a preliminary study involving 71 older adult patients with degenerative lumbar spinal stenosis who received the same treatment showed that at 3 months post-surgery, JOA score and spinal canal diameter were significantly increased compared with before surgery (P < 0.05). Discussion: Findings from this study may provide clinical evidence supporting that total laminectomy combined with lumbar pedicle screw fixation is a safe and reliable method for treatment of senile degenerative lumbar spinal stenosis because it rapidly alleviates lower back and leg pain and provides spine stability. Ethics and dissemination: This study was approved by Medical Ethics Committee of Qinghai Provincial People's Hospital of China (approval No. QHY201602G). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in August 2018. Data analysis will be performed in October 2019. The study will be completed in December 2019. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Protocol version: 1.0. Trial regis
{"title":"Total laminectomy combined with lumbar pedicle screw fixation for treatment of lower back and leg pain in older adult patients with degenerative lumbar spinal stenosis: study protocol for a self-control trial and preliminary results","authors":"Chun-Liang Li, Qiang Guo, Feng Qin, Wenqi Yan, Haitao Zhu, Kai Wang","doi":"10.4103/2542-3932.226193","DOIUrl":"https://doi.org/10.4103/2542-3932.226193","url":null,"abstract":"Background and objectives: Senile degenerative lumbar spinal stenosis typically manifests clinically as lower back and leg pain caused by compression of the nerve root. Conventional total laminectomy for degenerative lumbar spinal stenosis can quickly alleviate a patient's symptoms, but produces an unsatisfactory therapeutic effect because of spinal instability caused by degenerative spondylolisthesis, and also has many adverse reactions. The purpose of this study is to investigate whether total laminectomy combined with lumbar pedicle screw fixation for treatment of senile degenerative lumbar spinal stenosis can effectively reduce lower back and leg pain caused by compression of the nerve root, increase lumbar spine stability, and reduce adverse reactions. Design: A prospective, single-center, self-control, interventional trial. Methods: One hundred and sixty older adult patients with degenerative lumbar spinal stenosis who will receive treatment at the Department of Orthopedics, Qinghai Provincial People's Hospital, China will be included in this study. All patients will undergo total laminectomy combined with lumbar pedicle screw fixation, with follow-up at 3, 6, 9, and 12 months post-surgery. Outcome measures and preliminary results: The primary outcome measure of this study is recovery rate in Japanese Orthopedic Society (JOA) score at 12 months post-surgery, which is used to evaluate improvements in patients lower back and leg pain. Secondary outcome measures of this study include changes in JOA score, spinal canal diameter, lumbar spine morphology displayed on computed tomography images, and incidence of adverse events post-surgery. Results of a preliminary study involving 71 older adult patients with degenerative lumbar spinal stenosis who received the same treatment showed that at 3 months post-surgery, JOA score and spinal canal diameter were significantly increased compared with before surgery (P < 0.05). Discussion: Findings from this study may provide clinical evidence supporting that total laminectomy combined with lumbar pedicle screw fixation is a safe and reliable method for treatment of senile degenerative lumbar spinal stenosis because it rapidly alleviates lower back and leg pain and provides spine stability. Ethics and dissemination: This study was approved by Medical Ethics Committee of Qinghai Provincial People's Hospital of China (approval No. QHY201602G). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in August 2018. Data analysis will be performed in October 2019. The study will be completed in December 2019. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Protocol version: 1.0. Trial regis","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77958594","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 : 2018-01-01DOI: 10.4103/2542-3932.238438
Yi-huan Chen, Zheng-wu Peng, Xuan Zhang, Jie Bai, Shou-Fen Yu, Xiaosa Li, Xiao-Ling Qiang, P. Zhou, Hong He, Hua-ning Wang
Background and objectives: The human intestine contains a large amount of commensal bacteria. Under normal conditions, the intestinal microflora is stable, forms intestinal biological barriers, and promotes the growth and development of the organism. However, changes in the external environment can lead to disturbances in intestinal micro-organisms, causing host dysfunction and resulting in various types of disease. This study will investigate the role of intestinal microbes in the development of depression, bipolar disorder, and schizophrenia. Design: A case-control study. Methods: We recruited 50 patients with schizophrenia, 50 with depression, 50 with bipolar disorder, 50 with bipolar depressive episode, 50 with manic or hypomanic bipolar episode, and 50 age- and sex-matched healthy individuals who received physical examinations at the Department of Psychiatry of Xijing Hospital (China). Outcome measures: The primary outcome measure is the degree of change in fecal bacterial microflora after 3 months of pharmaceutical treatment. The secondary outcome measures are the type and content of small molecule metabolites in feces, the Hamilton Depression Scale score, the Young Mania Rating Scale score, the positive and negative syndrome scale score, and the Global Assessment of Functioning scale score before vs. after treatment. Discussion: The results of this study will reveal changes in intestinal microflora and metabolic patterns in patients with schizophrenia, depression, and bipolar disorder. These data may lead to biomarkers for disease diagnosis and provide new directions for investigation of possible mechanisms underlying the development of mental disorders. Ethics and dissemination: This study was approved by Medical Ethics Committee, Xijing Hospital, China (approval No. KY20172048-1). This study was disigned in May 2017, received ethical approval on September 6, 2017, and registered on October 18, 2017. Patient recuritement initiated in November 2017 and ended in February 2018. Genomics and metabolomics detection and data analysis initiated in March 2018 and will end in December 2018. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial data will be publicly accessible via ResMan. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ROC-17013029). Protocol version: 2.0.
{"title":"Differences in intestinal microflora and metabolites between patients with schizophrenia, depression, bipolar disorder, and healthy subjects: protocol for a case-control study","authors":"Yi-huan Chen, Zheng-wu Peng, Xuan Zhang, Jie Bai, Shou-Fen Yu, Xiaosa Li, Xiao-Ling Qiang, P. Zhou, Hong He, Hua-ning Wang","doi":"10.4103/2542-3932.238438","DOIUrl":"https://doi.org/10.4103/2542-3932.238438","url":null,"abstract":"Background and objectives: The human intestine contains a large amount of commensal bacteria. Under normal conditions, the intestinal microflora is stable, forms intestinal biological barriers, and promotes the growth and development of the organism. However, changes in the external environment can lead to disturbances in intestinal micro-organisms, causing host dysfunction and resulting in various types of disease. This study will investigate the role of intestinal microbes in the development of depression, bipolar disorder, and schizophrenia. Design: A case-control study. Methods: We recruited 50 patients with schizophrenia, 50 with depression, 50 with bipolar disorder, 50 with bipolar depressive episode, 50 with manic or hypomanic bipolar episode, and 50 age- and sex-matched healthy individuals who received physical examinations at the Department of Psychiatry of Xijing Hospital (China). Outcome measures: The primary outcome measure is the degree of change in fecal bacterial microflora after 3 months of pharmaceutical treatment. The secondary outcome measures are the type and content of small molecule metabolites in feces, the Hamilton Depression Scale score, the Young Mania Rating Scale score, the positive and negative syndrome scale score, and the Global Assessment of Functioning scale score before vs. after treatment. Discussion: The results of this study will reveal changes in intestinal microflora and metabolic patterns in patients with schizophrenia, depression, and bipolar disorder. These data may lead to biomarkers for disease diagnosis and provide new directions for investigation of possible mechanisms underlying the development of mental disorders. Ethics and dissemination: This study was approved by Medical Ethics Committee, Xijing Hospital, China (approval No. KY20172048-1). This study was disigned in May 2017, received ethical approval on September 6, 2017, and registered on October 18, 2017. Patient recuritement initiated in November 2017 and ended in February 2018. Genomics and metabolomics detection and data analysis initiated in March 2018 and will end in December 2018. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial data will be publicly accessible via ResMan. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ROC-17013029). Protocol version: 2.0.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87662767","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 : 2018-01-01DOI: 10.4103/2542-3932.226188
Bin Shi, Li-Zhuang Yang, Y. Liu, Xiaochu Zhang
Background and objectives: Controlling the urge to smoke that stems from a cue-induced craving is the key to successfully breaking the habit. Transcranial direct current stimulation (tDCS) has been shown to improve human control over cognition and behavior. Preliminary behavioral studies have shown that tDCS can reduce cigarette cravings. However, the underlying neural mechanism remains poorly understood. In this study, we used transcranial direct current to stimulate the dorsolateral prefrontal cortex in patients who were addicted to cigarettes. We analyzed the correlation between changes in brain function indicators (e.g., local brain activation and long-distance connectivity) caused by tDCS and the change in cigarette cravings, with the purpose of identifying the neural mechanism by which tDCS to the prefrontal lobe reduces cigarette cravings. Design: A prospective, single-center, randomized, controlled crossover trial. Methods: Forty-two patients addicted to cigarettes who received treatment in the Affiliated Hospital of Anhui Medical University, China received one session each of real and sham tDCS. The time interval between real and sham stimulations was 1 week. The order of stimulation was determined using a random number table. For real tDCS, stimulation intensity was 1 mA, and stimulation time was 30 minutes. For sham tDCS, stimulation intensity was increased to 1 mA within 30 seconds, and then decreased to 0 mA within the next 30 seconds. Stimulation was not performed within the subsequent 29 minutes. At the end of each stimulation session, functional magnetic resonance imaging was performed to record brain activity in patients during a smoking-cue task. Participants reported how much they craved cigarettes using a Visual Analog Scale before and after watching smoking scenes. Outcome measures and results: The primary outcome measure was the degree to which cigarette cravings increased after watching smoking scenes following each stimulation session. The secondary outcome measures were local brain activation and long-distance connectivity between activated brain regions after watching smoking scenes, as well as the incidence of reverse reactions following each stimulation session. After the data collection was complete, data from 32 of the 42 initial patients were included in the final analysis. The results revealed that the increase in cue-induced cigarette cravings was significantly reduced (t = 2.319, df = 31, P = 0.027) after real tDCS compared to sham tDCS. Significant effects were observed in the left superior frontal gyrus and left middle frontal gyrus. Psychophysiological interaction revealed that the connectivity between the dorsolateral prefrontal cortex and the right parahippocampal gyrus was correlated with the amount of increase in cue-induced cigarette cravings (r = 0.522, P = 0.002). Discussion: Based on fMRI findings, the present study was performed to identify the neural mechanism through which tDCS reduces cue-induced c
背景和目的:成功戒除吸烟习惯的关键是控制由提示引起的吸烟冲动。经颅直流电刺激(tDCS)已被证明可以改善人类对认知和行为的控制。初步的行为研究表明，tDCS可以减少对香烟的渴望。然而，潜在的神经机制仍然知之甚少。在这项研究中，我们使用经颅直流电刺激吸烟成瘾患者的背外侧前额叶皮层。我们分析了tDCS引起的脑功能指标变化(如局部脑激活和远距离连接)与香烟渴望的变化之间的相关性，旨在确定tDCS到前额叶减少香烟渴望的神经机制。设计:前瞻性、单中心、随机、对照交叉试验。方法:在安徽医科大学附属医院接受治疗的42例烟瘾患者分别接受1次真、假tDCS治疗。真实刺激与假刺激的时间间隔为1周。采用随机数表确定刺激顺序。对于真实tDCS，刺激强度为1 mA，刺激时间为30分钟。对于假性tDCS，刺激强度在30秒内增加到1 mA，然后在接下来的30秒内降低到0 mA。在随后的29分钟内没有进行刺激。在每次刺激结束时，进行功能性磁共振成像以记录患者在吸烟提示任务期间的大脑活动。参与者在观看吸烟场景之前和之后用视觉模拟量表报告了他们对香烟的渴望程度。结果测量和结果:主要结果测量是在每次刺激后观看吸烟场景后吸烟欲望增加的程度。次要结果测量是观看吸烟场景后的局部大脑激活和激活大脑区域之间的远距离连接，以及每次刺激后的反向反应发生率。数据收集完成后，42例初始患者中32例的数据被纳入最终分析。结果显示，与假tDCS相比，真实tDCS后线索诱导的香烟渴望的增加明显减少(t = 2.319, df = 31, P = 0.027)。在左侧额上回和左侧额中回观察到显著的影响。心理生理相互作用显示，背外侧前额叶皮层和右侧海马旁回之间的连性与线索诱导的香烟渴望增加的数量相关(r = 0.522, P = 0.002)。讨论:基于功能磁共振成像结果，本研究旨在确定tDCS减少线索诱导的香烟渴望的神经机制。初步结果表明，电刺激背外侧前额皮质通过调节与背外侧前额皮质相关的远距离耦合来减少渴望。伦理与传播:本研究经中国安徽医科大学生物医学伦理委员会批准(批准文号:20140241)。研究方案严格按照世界医学协会制定的《赫尔辛基宣言》执行。每位患者都获得了研究方案和程序的书面知情同意书。患者招募和数据收集于2014年3月开始。结果指标于2015年2月进行分析。审判于2015年3月结束。研究结果将通过在科学会议上的演讲和/或在同行评议的期刊上发表来传播。试验注册:本试验已在中国临床试验注册中心注册(注册号:ChiCTR-IPR-16007980)。
{"title":"Neural mechanism by which transcranial direct current stimulation reduces cigarette cravings: study protocol for a randomized controlled crossover trial","authors":"Bin Shi, Li-Zhuang Yang, Y. Liu, Xiaochu Zhang","doi":"10.4103/2542-3932.226188","DOIUrl":"https://doi.org/10.4103/2542-3932.226188","url":null,"abstract":"Background and objectives: Controlling the urge to smoke that stems from a cue-induced craving is the key to successfully breaking the habit. Transcranial direct current stimulation (tDCS) has been shown to improve human control over cognition and behavior. Preliminary behavioral studies have shown that tDCS can reduce cigarette cravings. However, the underlying neural mechanism remains poorly understood. In this study, we used transcranial direct current to stimulate the dorsolateral prefrontal cortex in patients who were addicted to cigarettes. We analyzed the correlation between changes in brain function indicators (e.g., local brain activation and long-distance connectivity) caused by tDCS and the change in cigarette cravings, with the purpose of identifying the neural mechanism by which tDCS to the prefrontal lobe reduces cigarette cravings. Design: A prospective, single-center, randomized, controlled crossover trial. Methods: Forty-two patients addicted to cigarettes who received treatment in the Affiliated Hospital of Anhui Medical University, China received one session each of real and sham tDCS. The time interval between real and sham stimulations was 1 week. The order of stimulation was determined using a random number table. For real tDCS, stimulation intensity was 1 mA, and stimulation time was 30 minutes. For sham tDCS, stimulation intensity was increased to 1 mA within 30 seconds, and then decreased to 0 mA within the next 30 seconds. Stimulation was not performed within the subsequent 29 minutes. At the end of each stimulation session, functional magnetic resonance imaging was performed to record brain activity in patients during a smoking-cue task. Participants reported how much they craved cigarettes using a Visual Analog Scale before and after watching smoking scenes. Outcome measures and results: The primary outcome measure was the degree to which cigarette cravings increased after watching smoking scenes following each stimulation session. The secondary outcome measures were local brain activation and long-distance connectivity between activated brain regions after watching smoking scenes, as well as the incidence of reverse reactions following each stimulation session. After the data collection was complete, data from 32 of the 42 initial patients were included in the final analysis. The results revealed that the increase in cue-induced cigarette cravings was significantly reduced (t = 2.319, df = 31, P = 0.027) after real tDCS compared to sham tDCS. Significant effects were observed in the left superior frontal gyrus and left middle frontal gyrus. Psychophysiological interaction revealed that the connectivity between the dorsolateral prefrontal cortex and the right parahippocampal gyrus was correlated with the amount of increase in cue-induced cigarette cravings (r = 0.522, P = 0.002). Discussion: Based on fMRI findings, the present study was performed to identify the neural mechanism through which tDCS reduces cue-induced c","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81224051","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 : 2018-01-01DOI: 10.4103/2542-3932.232075
A. Soza, B. Certanec, E. Tapia
Background and objectives: The precedents about the existence of bilateral modulatory neuronal pathways between vestibular nuclei and higher brain centers involved in mood regulation, plus previous reports of abnormal vestibular function in major depression, support the relevance of further investigation inquiring the role of the vestibular system in depression's physiopathology and vice versa. The aim of this investigation is to study the vestibular activity in major depression patients using the rotatory test technique. Methods: Totally 21 major depression subjects (average age 37.9 years) according to Diagnostic and Statistical Manual of Mental Disorders-V criterion, who scored 12 or more in the 21-item Hamilton Rating Scale for Depression (HRS-D21), and 20 control healthy subjects (average age 41.1 years) who scored less than 7 in the HRS-D21, were tested in the rotatory chair. The nystagmus (vestibular-ocular reflex consisting of ocular movements induced by the vestibular system), was registered by electronystagmography. For the quantification of right or left vestibular activity, we measured the nystagmus's slow phase velocity induced by right and leftward rotation of the chair correspondingly. Results: Depression group showed an asymmetric vestibular pattern of activity (right/left vestibular activity ratio = 0.77 ± 0.2), significantly different (P < 0.01) from healthy who presented symmetric vestibular function (right/left ratio = 1.1 ± 0.3). Conclusion: Major depressive patients show an abnormal pattern of vestibular activity with lower function at the right side compared to left. We discuss the meaning and the possible underlying physiopathologic mechanisms of this finding. Also, we raise the possibility to consider this particular kind of vestibular asymmetry as a potential biomarker of major depression. Trial registration: ClinicalTrials.gov identifier: NCT03421847.
{"title":"Abnormal vestibular asymmetries in patients with major depression","authors":"A. Soza, B. Certanec, E. Tapia","doi":"10.4103/2542-3932.232075","DOIUrl":"https://doi.org/10.4103/2542-3932.232075","url":null,"abstract":"Background and objectives: The precedents about the existence of bilateral modulatory neuronal pathways between vestibular nuclei and higher brain centers involved in mood regulation, plus previous reports of abnormal vestibular function in major depression, support the relevance of further investigation inquiring the role of the vestibular system in depression's physiopathology and vice versa. The aim of this investigation is to study the vestibular activity in major depression patients using the rotatory test technique. Methods: Totally 21 major depression subjects (average age 37.9 years) according to Diagnostic and Statistical Manual of Mental Disorders-V criterion, who scored 12 or more in the 21-item Hamilton Rating Scale for Depression (HRS-D21), and 20 control healthy subjects (average age 41.1 years) who scored less than 7 in the HRS-D21, were tested in the rotatory chair. The nystagmus (vestibular-ocular reflex consisting of ocular movements induced by the vestibular system), was registered by electronystagmography. For the quantification of right or left vestibular activity, we measured the nystagmus's slow phase velocity induced by right and leftward rotation of the chair correspondingly. Results: Depression group showed an asymmetric vestibular pattern of activity (right/left vestibular activity ratio = 0.77 ± 0.2), significantly different (P < 0.01) from healthy who presented symmetric vestibular function (right/left ratio = 1.1 ± 0.3). Conclusion: Major depressive patients show an abnormal pattern of vestibular activity with lower function at the right side compared to left. We discuss the meaning and the possible underlying physiopathologic mechanisms of this finding. Also, we raise the possibility to consider this particular kind of vestibular asymmetry as a potential biomarker of major depression. Trial registration: ClinicalTrials.gov identifier: NCT03421847.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86708167","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 : 2018-01-01DOI: 10.4103/2542-3932.232080
L. Du, L. Shan, Xiaojing Yue, Hong-Hua Li, F. Jia
Background and objectives: Newborns with perinatal risk factors and abnormal general motor quality assessment are at high risk of developing cerebral palsy. The treatment is earlier, the prognosis is better. This trial will investigate whether, combined with conventional early interventional therapy, the use of mouse nerve growth factor in high-risk infants can improve their motor and cognitive abilities. Design: This is a prospective, single-center, randomized, parallel, controlled, clinical trial. Methods: This trial will be conducted in the Department of Developmental Behavioral Pediatrics, the First Hospital of Jilin University, China. One hundred high-risk infants meeting the inclusion criteria will be recruited and randomized into control and treatment groups. Only participants in the treatment group will undergo the early treatment of mouse nerve growth factor via gluteus maximus injections, 20 μg per dose, once a day, 10 consecutive days per month. The treatment will last for 6 months. Both groups will receive standard early intervention therapies. Outcome measures: The primary outcome measure is the incidence of the developmental disorders cerebral palsy and non-cerebral palsy at the actual age or corrected age of 12 months. The secondary outcome measures are Gesell Developmental Schedule scores at the actual age or corrected age of 12 months, Gross Motor Function Measure score at 6 and 12 months of treatment, and adverse events during the trial. Discussion: If treatment with mouse nerve growth factor is found to be safe and effective for the high-risk infants, new options for the early-stage clinical treatment for such infants may be developed. Ethics and dissemination: This trial has been approved by the Ethics Committee of First Hospital of Jilin University of China [approval number: 2017 (2017-290)]. This trial was designed in August 2017. Ethics approval was done in October 2017. This trial was registered in November 2017. The recruitment of subjects began in December 2017. Data analysis will be finished in December 2021. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012774). Protocol version (2.0).
{"title":"Does early injection of mouse nerve growth factor affect motor and cognitive abilities in high-risk infants? study protocol for a randomized parallel-controlled trial","authors":"L. Du, L. Shan, Xiaojing Yue, Hong-Hua Li, F. Jia","doi":"10.4103/2542-3932.232080","DOIUrl":"https://doi.org/10.4103/2542-3932.232080","url":null,"abstract":"Background and objectives: Newborns with perinatal risk factors and abnormal general motor quality assessment are at high risk of developing cerebral palsy. The treatment is earlier, the prognosis is better. This trial will investigate whether, combined with conventional early interventional therapy, the use of mouse nerve growth factor in high-risk infants can improve their motor and cognitive abilities. Design: This is a prospective, single-center, randomized, parallel, controlled, clinical trial. Methods: This trial will be conducted in the Department of Developmental Behavioral Pediatrics, the First Hospital of Jilin University, China. One hundred high-risk infants meeting the inclusion criteria will be recruited and randomized into control and treatment groups. Only participants in the treatment group will undergo the early treatment of mouse nerve growth factor via gluteus maximus injections, 20 μg per dose, once a day, 10 consecutive days per month. The treatment will last for 6 months. Both groups will receive standard early intervention therapies. Outcome measures: The primary outcome measure is the incidence of the developmental disorders cerebral palsy and non-cerebral palsy at the actual age or corrected age of 12 months. The secondary outcome measures are Gesell Developmental Schedule scores at the actual age or corrected age of 12 months, Gross Motor Function Measure score at 6 and 12 months of treatment, and adverse events during the trial. Discussion: If treatment with mouse nerve growth factor is found to be safe and effective for the high-risk infants, new options for the early-stage clinical treatment for such infants may be developed. Ethics and dissemination: This trial has been approved by the Ethics Committee of First Hospital of Jilin University of China [approval number: 2017 (2017-290)]. This trial was designed in August 2017. Ethics approval was done in October 2017. This trial was registered in November 2017. The recruitment of subjects began in December 2017. Data analysis will be finished in December 2021. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012774). Protocol version (2.0).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77758466","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 : 2017-10-01DOI: 10.4103/2542-3932.217494
M. Georgiopoulos, Jack Tsonis, C. Apostolopoulou, C. Constantoyannis
During neurosurgical operations, the soft material of the brain, the cerebrospinal fluid (CSF), the opening of the skull's cavity, the opening of the dura mater, the CSF loss along with gravity and other factors make the brain susceptible to the brain-shift phenomenon (displacement of the brain in relation with its natural position captured during imaging acquisition). As a result, after some point of the operation the neurosurgeon cannot really rely on the navigation system's guidance. The navigational inaccuracies caused by the brain-shift phenomenon and the demand for updated intraoperative imaging acquisition aiming to increase accuracy and reliability led to the development of intraoperative imaging systems. Such systems are the intraoperative ultrasound device, and the intraoperative computed tomography (ioCT) or magnetic resonance imaging (ioMRI) scanners. Each system is characterized by its own advantages and disadvantages, which are described in the present review. As a conclusion, intraoperative imaging systems provide very important advantages in various types of operations by updating the imaging scan. However, their benefit is unclear in some instances, while ioCT and especially ioMRI are associated with huge costs affordable only by specific hospitals worldwide.
{"title":"Intraoperatively updated navigation systems: the solution to brain shift","authors":"M. Georgiopoulos, Jack Tsonis, C. Apostolopoulou, C. Constantoyannis","doi":"10.4103/2542-3932.217494","DOIUrl":"https://doi.org/10.4103/2542-3932.217494","url":null,"abstract":"During neurosurgical operations, the soft material of the brain, the cerebrospinal fluid (CSF), the opening of the skull's cavity, the opening of the dura mater, the CSF loss along with gravity and other factors make the brain susceptible to the brain-shift phenomenon (displacement of the brain in relation with its natural position captured during imaging acquisition). As a result, after some point of the operation the neurosurgeon cannot really rely on the navigation system's guidance. The navigational inaccuracies caused by the brain-shift phenomenon and the demand for updated intraoperative imaging acquisition aiming to increase accuracy and reliability led to the development of intraoperative imaging systems. Such systems are the intraoperative ultrasound device, and the intraoperative computed tomography (ioCT) or magnetic resonance imaging (ioMRI) scanners. Each system is characterized by its own advantages and disadvantages, which are described in the present review. As a conclusion, intraoperative imaging systems provide very important advantages in various types of operations by updating the imaging scan. However, their benefit is unclear in some instances, while ioCT and especially ioMRI are associated with huge costs affordable only by specific hospitals worldwide.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78753685","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 : 2017-10-01DOI: 10.4103/2542-3932.217490
S. Jafri, Y. Husen, K. Ahmed, S. Ibrahim
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.
{"title":"Spectrum of MRI brain findings in subacute sclerosing panencephalitis","authors":"S. Jafri, Y. Husen, K. Ahmed, S. Ibrahim","doi":"10.4103/2542-3932.217490","DOIUrl":"https://doi.org/10.4103/2542-3932.217490","url":null,"abstract":"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.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83773965","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 : 2017-10-01DOI: 10.4103/2542-3932.217492
A. Soza, S. Barroilhet, P. Vohringer
Background and objectives: Bipolar disorder (BD) is a neuropsychiatric disorder characterized by cyclic changes in mood between hypoactive, pessimistic (depressive phase) and hyperactive, optimistic (manic/hypomanic phase). Prior studies in major depression patients show that the right side of the vestibular system (inner ear's equilibrium system) is less active compared to the left. It suggests a relationship between mood and abnormal lateralization of the vestibular activity. This exploratory investigation analyzes the right and left vestibular activity in different mood phases of BD and healthy controls. Design: A transversal cross-sectional study. Methods: We will study and compare the lateralization of the vestibular activity of BD I or II patients, who match the selection criteria for different mood phases: depression, mania/hypomania, euthymia and healthy controls (6 patients each group). Outcome measures: For vestibular evaluation, we will use rotary chair technique and electronystagmography. The primary outcome measure is the per- and post-rotatory asymmetry. The secondary outcome measures are the slow phase velocity of the nystagmus, the rhythmicity of nystagmus, and the type of slow ocular tracking. Discussion: This study addresses the relationship between mood states and abnormal right-left side lateralization of the vestibular activity in BD patients. Ethics and dissemination: The study protocol was approved by the ethics committee of Servicio de Salud Metropolitano Oriente, in Santiago, Chile on June 21st, 2016. Participants will provide written informed consent prior to participation in the trial. Trial registration: ClinicalTrials.gov identifier: NCT02827045 on July 6th, 2016.
{"title":"A vestibular biomarker of manic and depressive phase in bipolar disorder","authors":"A. Soza, S. Barroilhet, P. Vohringer","doi":"10.4103/2542-3932.217492","DOIUrl":"https://doi.org/10.4103/2542-3932.217492","url":null,"abstract":"Background and objectives: Bipolar disorder (BD) is a neuropsychiatric disorder characterized by cyclic changes in mood between hypoactive, pessimistic (depressive phase) and hyperactive, optimistic (manic/hypomanic phase). Prior studies in major depression patients show that the right side of the vestibular system (inner ear's equilibrium system) is less active compared to the left. It suggests a relationship between mood and abnormal lateralization of the vestibular activity. This exploratory investigation analyzes the right and left vestibular activity in different mood phases of BD and healthy controls. Design: A transversal cross-sectional study. Methods: We will study and compare the lateralization of the vestibular activity of BD I or II patients, who match the selection criteria for different mood phases: depression, mania/hypomania, euthymia and healthy controls (6 patients each group). Outcome measures: For vestibular evaluation, we will use rotary chair technique and electronystagmography. The primary outcome measure is the per- and post-rotatory asymmetry. The secondary outcome measures are the slow phase velocity of the nystagmus, the rhythmicity of nystagmus, and the type of slow ocular tracking. Discussion: This study addresses the relationship between mood states and abnormal right-left side lateralization of the vestibular activity in BD patients. Ethics and dissemination: The study protocol was approved by the ethics committee of Servicio de Salud Metropolitano Oriente, in Santiago, Chile on June 21st, 2016. Participants will provide written informed consent prior to participation in the trial. Trial registration: ClinicalTrials.gov identifier: NCT02827045 on July 6th, 2016.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77892029","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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