Asia Pacific Journal of Clinical Trials: Nervous System Diseases最新文献

{"title":"Diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) positron emission tomography/computed tomography in patients with brain gliomas: study protocol for an open-label single-arm clinical trial","authors":"J. Zang, Hao Wang, Jingjing Zhang, Zhaohui Zhu","doi":"10.4103/2542-3932.198959","DOIUrl":"https://doi.org/10.4103/2542-3932.198959","url":null,"abstract":"Background: Gastrin-releasing peptide receptor is particularly expressed in gliomas, while the peptide bombesin [BBN(7-14)] has the complete C-terminal structure of human gastrin-releasing peptide. Glioma-specific imaging agents can therefore be constructed from BBN, for example 68Ga-NOTA-Aca-BBN(7-14). For consideration of the clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body positron emission tomography/computed tomography (PET/CT) study was designed to investigate the diagnostic effectiveness and safety of 68Ga-NOTA-Aca-BBN(7-14) in patients with brain gliomas. Methods/Design: This is an open-label single-arm clinical trial that will be conducted at Peking Union Medical College Hospital in Beijing, China. Thirty patients in suspicion of brain gliomas scheduled for surgical treatment will be recruited and subjected to PET/CT via intravenous injection of 68Ga-NOTA-Aca-BBN(7-14). The primary outcome measure will be the standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in brain glioma at 30 minutes after injection. Secondary outcomes include the diagnostic accuracy rate of 68Ga-NOTA-Aca-BBN(7-14) PET/CT, and adverse events after injection. Discussion: Diagnostic performance and safety assessment of 68Ga-NOTA-Aca-BBN(7-14) in brain gliomas will provide new insights into the specific PET/CT diagnosis of brain gliomas. Trial registration: ClinicalTrials.gov identifier: NCT02520882, registered on 2 August 2015. Ethics: This study protocol has been approved by the Ethics Committee of Peking Union Medical College Hospital in China (approval No. S-714), and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: An informed consent will be obtained from each patient or his/her guardian prior to participation in the study.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"80 1","pages":"23 - 29"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81263866","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}

{"title":"Effects of dexmedetomidine combined with sodium creatine phosphate on inflammation, oxidative stress, and neurological function recovery in patients undergoing intracranial hematoma evacuation: study protocol for a multi-center, prospective randomized parallel-cohort controlled trial","authors":"Chao-liang Tang, Juan Li, Bo Zhao, Si Shi, Hao Shen, Z. Xia","doi":"10.4103/2542-3932.198958","DOIUrl":"https://doi.org/10.4103/2542-3932.198958","url":null,"abstract":"Background: In treating intracranial hematoma, dexmedetomidine (Dex) exhibits neuroprotective effects by preventing cognitive decline, and sodium creatine phosphate (SCP) exhibits neuroprotective effects by reducing cell death, maintaining the blood-brain barrier and improving interstitial cerebral edema. Few studies have examined the effects of Dex combined with SCP on perioperative inflammation and oxidative stress response, or recovery of neurological function. Methods/Design: Here we propose a multi-center, prospective randomized parallel-cohort controlled trial, to be performed at Anhui Provincial Hospital and Renmin Hospital of Wuhan University, China. After screening against inclusion and exclusion criteria, 80 patients scheduled to receive intracranial hematoma evacuation will be randomly divided into control, Dex, SCP, and Dex + SCP groups, with 20 patients per group. Under general anesthesia, all patients will undergo craniotomy for hematoma removal. In the Dex and Dex + SCP groups, an intravenous bolus of Dex (0.6 μg/kg) will be administered 10 minutes before anesthesia induction and thereafter intravenous administration of Dex (0.4 μg/kg/h) will be given. In the SCP, and Dex + SCP groups, 1.0 g SCP will be administered 10 minutes before anesthesia induction. The primary outcome measure is the difference in postoperative 72-hour Glasgow Coma Scale (GCS) score and postoperative 12-hour GCS score. The secondary outcome measures include differences in postoperative 48-hour and 24-hour GCS scores and postoperative 12-hour GCS score; plasma levels of inflammatory and oxidative stress markers, and pathological changes in brain tissue before anesthesia induction and at the end of surgery; and physiological indices during surgery. Discussion: We evaluate whether results from the proposed study protocol will provide evidence that the use of Dex combined with SCP in patients undergoing intracranial hematoma evacuation is feasible. Trial registration: The study protocol was registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn/) on 11 December 2014 (registration number: ChiCTR-IPR-14005656). Ethics: The study protocol was approved by Ethics Committee, Anhui Provincial Hospital, China on 25 November 2014 (approval No. 2014-ethics-39) and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from patient′s guardians or clients prior to enrollment in the clinical trial.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"355 1","pages":"1 - 8"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78100622","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}

{"title":"Scalp acupuncture for dyskinesia after ischemic stroke: Study protocol for a parallel randomized controlled clinical trial","authors":"Qin-hui Fu, Jun Wang, J. Pei","doi":"10.4103/2542-3932.205197","DOIUrl":"https://doi.org/10.4103/2542-3932.205197","url":null,"abstract":"Background: Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture. Methods/Design: We will conduct a randomized, controlled, parallel, clinical trial. We will collect 116 ischemic stroke patients with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 30° and an insertion depth of 25–35 mm in the anterior oblique line of vertex-temporal (MS6). Twisting speed will be 200 times per minute. Acupuncture will be performed 30 minutes, once per day. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer assessment motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline. The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine. Discussion: This trial will provide objective data on the effectiveness of scalp acupuncture in ischemic stroke patients with dyskinesia. Trial registration: ClinicalTrials.gov identifier: NCT03120650. Ethics: The study protocol has been approved by the Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine of China on 23 October 2013, approval number 2013LCSY056. Informed consent: Written informed consent will be provided by subject guardians.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"1 1","pages":"72 - 79"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89251316","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}

{"title":"Safety and efficacy of allogeneic umbilical cord blood therapy combined with erythropoietin in children with cerebral palsy: study protocol for a double-blind, randomized, placebo-controlled trial","authors":"K. Cho, Kyunghoon Min, S. Lee, MinYoung Kim","doi":"10.4103/2542-3932.217491","DOIUrl":"https://doi.org/10.4103/2542-3932.217491","url":null,"abstract":"Background and objectives: Cerebral palsy typically results from brain injury during prenatal, perinatal, or infant period. Established medical management involves rehabilitation therapy with comprehensive multidisciplinary approach to minimize various complications and to improve brain plasticity. Recently, direct brain tissue modifying therapy using stem cell therapy has been investigated as a new therapeutic modality. In this study, the combination therapy of allogeneic umbilical cord blood and/or erythropoietin is investigated to find out the efficacy and safety in children with cerebral palsy over empirical rehabilitation therapy. Design: A randomized, double blind, controlled trial. Methods: Patients with cerebral palsy who visited Rehabilitation medicine center in CHA Bundang Medical Center, Republic of Korea from October 2013 to October 2015 are included in this trial. A sample size of 120 patients is needed. Patients will be randomly assigned to three groups of cord blood treatment or a control group. Cord blood treatment group will receive either cord blood and erythropoietin, or cord blood and erythropoietin placebo, or placebo cord blood and erythropoietin in addition to conservative rehabilitation therapy. Outcome measures: The primary outcome of the study is the efficacy of combination therapy of allogeneic cord blood stem cell and erythropoietin and either monotherapy in terms of the change from baseline motor function assessments including Gross Motor Function Measure, Gross Motor Performance Measure, motor and mental subscales of Korean version Bayley Scales of Infant Development, 2nd edition. The secondary outcomes of the study include other functional assessment tools, imaging studies (fractional anisotropy of diffusion tensor imaging and positron emission tomography), electroencephalography, and evoked potentials. Discussion: The results of this trial will provide optimal evidence of cord blood transplantation with or without erythropoietin as a therapeutic modality in children with cerebral palsy. Ethics and dissemination: The study will be reviewed by IRB. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial had been registered in the ClinicalTrials.gov (identifier: NCT0199114) on 17 November 2013.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"44 1","pages":"129 - 139"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77948985","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}

{"title":"Recognition and early aerobic exercise in prodrome of bipolar disorder: study protocol for a randomized controlled trial","authors":"Gui-yun Xu, Xiaodong Chen, Ting Li, Kun Chen, Kangguang Lin","doi":"10.4103/2542-3932.198960","DOIUrl":"https://doi.org/10.4103/2542-3932.198960","url":null,"abstract":"Background: Numerous studies have demonstrated that a long symptomatic prodromal phase (9-12 years) exists before the onset of bipolar disorder. Offspring of patients with bipolar disorders are more likely to present prodromal symptoms compared with those of healthy parents. Methods/Design: This ongoing study is a single-center, randomized parallel-controlled trial. Eligible 120 offspring of patients with bipolar disorder, aged 10-25 years, in the prodromal stage, will be included in this study and randomized to receive psychoeducation or aerobic exercise for 3 months. The primary outcomes are changes in Clinical Global Impressions Scale scores and diagostic status from baseline to 3-month follow-up. The secondary outcomes are changes in Hamilton Depression Rating Scale scores, Young Mania Rating, Brief Psychiatric Rating Scale scores, Hamilton Anxiety Rating Scale scores, Global Assessment Scale scores from baseline to 3-month follow-up. Discussion: The main aim of this study is to identify the prodromal stage of bipolar disorder, and to propose the effective prevention strategies for bipolar disorder. The trial results will provide important clinical evidence for the preventive effect of aerobic exercise on bipolar disorder. Trial registration: ClinicalTrials.gov identifier NCT01863628; registered on 21 May 2013. Ethics: This study protocol was approved by the Ethics Committee of Guangzhou Huiai Hospital, China (approval No. 2016048) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written informed consent will be obtained from each study participant and his/her legal guardian(s) prior to enrolment.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"1 1","pages":"9 - 14"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78671294","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}

{"title":"Efficacy and safety of glucocorticoids combined with hyperbaric oxygen therapy in the treatment of delayed encephalopathy after acute carbon monoxide poisoning: study protocol for a randomized controlled trial","authors":"Wen-ping Xiang, Hui Xue, Bao-jun Wang","doi":"10.4103/2542-3932.198961","DOIUrl":"https://doi.org/10.4103/2542-3932.198961","url":null,"abstract":"Background: About half of patients with acute carbon monoxide (CO) poisoning suffer from delayed post-anoxic encephalopathy. Days or weeks after apparent recovery from acute CO poisoning, patients present with sudden onset neurophysiological symptoms, mainly symptoms of dementia, with a high risk of permanent disability or death. Glucocorticoids not only regulate the biosynthesis and metabolism of blood glucose, fat, and protein, but also inhibit the immune response and exhibit anti-inflammatory, anti-toxic, and anti-shock effects. Glucocorticoids can improve the clinical symptoms of delayed encephalopathy; however, the therapeutic effects of glucocorticoids combined with hyperbaric oxygen therapy (HBOT) on delayed encephalopathy after acute CO poisoning are poorly understood. Methods/Design: This is a single-center, prospective, single-blind, randomized controlled trial, which will be performed at Baotou Center Hospital, China. A total of 120 eligible patients with delayed encephalopathy after acute CO poisoning will be randomly assigned to receive either basic treatment + HBOT + intravenous dexamethasone (trial group, n = 60) or basic treatment + HBOT (control group, n = 60). Intravenous injection of dexamethasone (10 mg, once a day, for 14 successive days) will be performed. HBOT (once a day, for 14 successive days) will be administered through a multi-place hyperbaric chamber that will be pressurized with 100% O 2 to 2-2.2 atmospheres absolute within 25 minutes, followed by 60 minutes of pressure stabilization, 10 minutes of resting, and 25 minutes of depressurization. The primary and secondary outcome measures of this study will be evaluated at baseline, 7, 14, 30, 60 and 90 days after treatment. The primary outcome measure is the Barthel Index of Activities of Daily Living change. The secondary outcome measures are Mini-Mental State Examination score, modified Ashworth Scale score and European Quality of Life-5 Dimensions questionnaire score, as well as adverse reactions and death rate. Discussion: This study will be conducted to analyze the clinical therapeutic efficacy and safety of glucocorticoids combined with hyperbaric oxygen therapy in the treatment of delayed encephalopathy after acute CO poisoning. Trial registration: This study protocol was registered with Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-16009743) on 5 November 2016. Ethics: This study protocol has been approved by the Ethics Committee, Baotou Central Hospital, China and will be performed in accordance with Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from patients′ relatives prior to involvement in the clinical trial.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"409 1","pages":"15 - 22"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79827915","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}

{"title":"Trigeminal nerve stimulation for the treatment of major depressive disorder and obsessive-compulsive disorder: a case study","authors":"A. Trevizol, I. Sato, Q. Cordeiro","doi":"10.4103/2542-3932.198962","DOIUrl":"https://doi.org/10.4103/2542-3932.198962","url":null,"abstract":"Neuromodulation techniques have been proposed as add-on strategies for modulating brain areas involved in obsessive-compulsive disorder symptoms. Trigeminal nerve stimulation is a novel neuromodulation technique, which, to date, has not yet been explored for obsessive-compulsive disorder treatment. In this report, we describe a 52-year-old female patient suffering from major depressive disorder and obsessive-compulsive disorder for 18 and 32 years, respectively and successfully undergoing a trigeminal nerve stimulation intervention protocol (10 consecutive daily trigeminal nerve stimulation sessions), with amelioration of symptoms. Cognitive function was not obviously altered as assessed by the Montreal Cognitive Assessment. Major depressive disorder and obsessive-compulsive disorder symptoms assessed using the Yale-Brown Obsessive-Compulsive Scale and the 17-item Hamilton Depression Rating Scale substantially improved after the 10-day treatment course and remained stable after 1-month follow-up (30 days after final trigeminal nerve stimulation). The patient reported significant global clinical gains and mild diurnal sleepiness without severe adverse effects. Trigeminal nerve stimulation has been studied for the treatment of various neuropsychiatric disorders that share common functional alterations at the frontal cortex and subcortical areas, usually altered in obsessive-compulsive disorder. We present the first case report on trigeminal nerve stimulation for co-morbid obsessive-compulsive disorder and major depressive disorder. These encouraging results should be seen as hypothesis-driving for further controlled randomized trials exploring the impact of trigeminal nerve stimulation in the treatment of obsessive-compulsive disorder.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"81 1","pages":"30 - 32"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82307018","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}

{"title":"Bispectral index-guided fast track anesthesia by sevoflurane infusion combined with dexmedetomidine for intracranial aneurysm embolization: study protocol for a multi-center parallel randomized controlled trial","authors":"Chao-liang Tang, Juan Li, Bo Zhao, Z. Xia","doi":"10.4103/2468-5577.193145","DOIUrl":"https://doi.org/10.4103/2468-5577.193145","url":null,"abstract":"Background: After intracranial aneurysm embolization, rapid recovery from general anesthesia is necessary for timely monitoring of adverse events. Fast-track anesthesia using a balanced technique or combination of drugs at their minimum required dosages is preferred for these neurosurgical patients. However, fast-track anesthesia is still limited by a lack of standardization and quality control standards. Methods/Design: A multi-center, parallel, randomized controlled clinical trial will be conducted at Anhui Provincial Hospital and Renmin Hospital of Wuhan University, China. One hundred and twenty patients with intracranial aneurysm will be randomly assigned to a normal saline group and a dexmedetomidine group. General anesthesia will be induced intravenously with propofol. Additionally, either 1.0 μg/kg dexmedetomidine or normal saline will be delivered completely within 10 minutes before anesthesia induction. Once anesthesia has begun, dexmedetomidine (0.3 μg/kg per hour) or normal saline will be continuously infused. Intraoperatively, anesthesia will be maintained with 2-3% sevoflurane. Primary outcomes will be anesthesia time, operative time, time from the end of anesthesia until recovering spontaneous breathing, time until eye opening on command, and time until orientation to time and place. Secondary outcomes will be dose of sevoflurane, Visual Analogue Scale score, and bispectral index. Discussion: In this trial, we will assess the clinical efficacy of sevoflurane anesthesia with dexmedetomidine as a fast track anesthesia for intracranial aneurysm embolization. Trial registration: This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-IPR-16008113) on 17 March 2016. Ethics: Written approval for this trial has been obtained from the Ethics Committee of the Anhui Provincial Hospital of China (approval No. 2015-31). This study will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Prior to the trial, participants and their family members will be informed of the risks and benefits of this trial. Written informed consent will be obtained from each participant.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"30 1","pages":"177 - 185"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89342432","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}

{"title":"Effect of intravenous acetaminophen on post-operative opioid-related complications: study protocol for a randomized, placebo-controlled trial","authors":"W. Saasouh, N. Jones, Taylor Stang, K. Hovsepyan, Christine Chang, A. Turan","doi":"10.4103/2468-5577.193142","DOIUrl":"https://doi.org/10.4103/2468-5577.193142","url":null,"abstract":"Background: Unrelieved post-operative pain leads to physiological and psychological consequences which worsen outcomes. Patients still report a 31% incidence of severe pain and 47% incidence of moderate pain after surgery. Multimodal analgesia aims to improve satisfaction while reducing side effects. Opioids are the most common treatment for post-operative pain; however, acute tolerance and opioid-induced hyperalgesia increase opioid requirements and the risk of side effects. Previous studies with acetaminophen have shown consistent and clinically important opioid-sparing effects but were unable to demonstrate significant reductions in opioid-related adverse events (inadequate sample sizes, poorly monitored complications). Specifically, we propose to test the primary hypothesis that total duration of hypoxia (defined as saturation of peripheral oxygen (SpO 2 ) < 90%) is less in patients receiving intravenous acetaminophen than placebo. Methods/Design: A total of 528 patients undergoing elective open or laparoscopic abdominal surgery will be included in this prospective, randomized, double-blinded, placebo-controlled trial. Patients who have renal disease, liver disease, acetaminophen allergy, are on warfarin therapy, or are receiving regional blocks will be excluded. The incidence and duration of hypoxic events will be the primary outcome of the study. Secondary outcomes include opioid consumption, pain scores, post-operative nausea and vomiting, sedation, fatigue, respiratory rate, movement, and cost-benefit analysis. We will use a ViSi mobile device (Sotera Wireless, San Diego, CA, USA) that will provide continuous non-invasive pulseoximetry, blood pressure, skin temperature, and patient position. Respiratory function will be measured using an ExSpiron (Respiratory Motion Inc., Waltham, MA, USA) monitor which provides continuous non-invasive monitoring of tidal volume, respiratory rate, and minute ventilation. Discussion: The outcomes will reveal the effect of peri-operative IV acetaminophen use on post-operative opioid-related complications. Continuous non-invasive monitoring of vital signs is expected to accurately assess opioid-related complications after major abdominal surgery and provide reliable results correlated with opioid use. The use of novel technology in the post-operative setting permits the collection of a dense amount of data and eliminates gaps in post-operative vital sign measurements. Trial registration: ClinicalTrials.gov identifier: NCT02156154, registered on 3 June 2014. Ethics: The study protocol was approved by the Cleveland Clinic Institutional Review Board (IRB) on 28 April 2014, approval number 14-241. Informed consent: Written informed consent will be obtained from participants or their guardians.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"7 1","pages":"154 - 163"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80478154","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}

{"title":"Effectiveness of cerebellar repetitive transcranial magnetic stimulation in essential tremor: study protocol for a randomized, sham-controlled trial","authors":"A. Shoeibi, N. Olfati","doi":"10.4103/2468-5577.193146","DOIUrl":"https://doi.org/10.4103/2468-5577.193146","url":null,"abstract":"Background: Recent studies have shown that the cerebellum has a significant role in development of essential tremor and repetitive transcranial magnetic stimulation (rTMS) has therapeutic effects on its motor symptoms. Methods/Design: This is a prospective, randomized, triple-blind, sham-controlled, add-on, crossover trial involving patients with essential tremor. Thirty patients will be included and randomized to either real rTMS (900 daily pulses of rTMS over each cerebellar hemisphere) or sham stimulation (low current electrical stimulation). After 2 months of follow-up, patients will undergo crossover and receive the other treatment. For the primary outcome measure, patients will be assessed using Fahn-Tolosa-Marin scale. Adverse events will be assessed as the secondary outcome measure. Discussion: This study evaluates the effect of cerebellar rTMS on tremor severity of patients afflicted with essential tremor, and aims to address the shortcomings of previous studies using a relatively larger sample size and randomized, sham-controlled, crossover design. Trial registration: This trial has been registered at ClinicalTrials.gov (identifier: NCT02704793) on 5 March 2016 and also at Iranian Registry of Clinical Trials (IRCT) (registration ID: IRCT2015100824428N1) on 1 April 2016. Ethics: This study has been approved by the Research Ethics Committee of Mashhad University of Medical Sciences, Iran (approval number: ir.mums.sm.rec.1394.353). Informed consent: Written informed consent will be obtained from all participants.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"57 1","pages":"186 - 190"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73688894","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}