• Users Online: 98
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Contacts Reader Login
Export selected to
Endnote
Reference Manager
Procite
Medlars Format
RefWorks Format
BibTex Format
  Citation statistics : Table of Contents
   2016| July-September  | Volume 1 | Issue 3  
    Online since October 13, 2016

 
 
  Archives   Previous Issue   Next Issue   Most popular articles   Most cited articles
 
Hide all abstracts  Show selected abstracts  Export selected to
  Cited Viewed PDF
STUDY PROTOCOL
Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial
Serena Amici, Pamela Iannizzi, Alessandra Di Pucchio, Iosief Abraha, Alessandro Montedori, Rabih Chattat, Nicola Vanacore
July-September 2016, 1(3):99-106
DOI:10.4103/2468-5658.191352  
Background: The activity of "caregiving" for people affected with Alzheimer's disease (AD) is associated with an augmentation in health problems (anxiety, depression, stress, increased mortality), as well as in social and financial problems. Different methods of counselling, to reduce caregiver anxiety and depression, have been shown to be effective. Methods/Design: This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups. Two hundred and sixty-four caregivers of AD patients will be randomly allocated to the modified Mittelmann psychosocial intervention or an educational intervention. The treatment will consist of 6 hours of counselling and psychosocial support to caregivers, administered by psychologists, along with a specific telephone support service, whereas the active control treatment will be 6 hours of general information about AD. The primary endpoint is change in caregiver burden measured with the Zarit Burden Interview. Secondary endpoints comprise caregiver depression, anxiety and quality of life. All endpoints will be measured at baseline, 6, 12 and 24 months post treatment. Discussion: The results of this trial will be helpful to supply the efficacy of early counselling and psychosocial support for AD caregivers and offer in-depth useful information for stakholders and policy makers to implement strategies for caregivers. Trial registration: Clinical Trials.gov identifier: NCT02685787; registered on 6 February 2016. Ethics: This trial has been approved by Umbria Ethical Review Committee, Italy and will be performed in accordance with the norms on Good Clinical Practice and the Helsinki Declaration. Informed consent: Written informed consent will be obtained from the caregivers.
  3 7,899 611
L-carnitine for reducing cardio-metabolic risk in patients with obstructive sleep apnea: study protocol of a randomized, double-blind, placebo-controlled trial
Marta Stelmach-Mardas, Paweł Bogdański, Marcin Mardas, Monika Szulinska, Jarosław Walkowiak, Tomasz Piorunek
July-September 2016, 1(3):134-140
DOI:10.4103/2468-5658.191356  
Background: Dyslipidemia and insulin resistance are diagnosed very often in obstructive sleep apnea patients; therefore the novel therapies based on the components involved in lipid and carbohydrates metabolism are still being searched for. L-carnitine may play a positive role in energy metabolism and in the reduction of cardio-metabolic risk factors. The present trial aims to investigate the potential role of L-carnitine in lipid and carbohydrates metabolism with precision non-invasive measurements in obstructive sleep apnea patients. Methods/Design: This ongoing study is a randomized, double-blind, placebo controlled, 2-arm parallel-group trial. A total of 80 eligible patients aged 18-80 with obstructive sleep apnea will be randomized in a 1:1 ratio to receive either placebo (placebo group) or L-carnitine (study group) for 8 weeks. Primary outcome measures are changes in lipid and carbohydrates metabolism. Secondary outcome are changes in non-invasive haemodynamic measurements: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) will be assessed. All outcome measures will be assessed at baseline, 4, 8 weeks, and 6 months post-intervention. Discussion: The novelty of this randomized controlled trial is the supplementation of L-carnitine connected with a mobile application for measuring medication adherence. Combined application of non-invasive haemodynamic measurement with assessment of lipid and glucose metabolism will allow us to examine the potential merit of routine supplementation of L-carnitine in patients suffering from obstructive sleep apnea. Trial registration: ClinicalTrials.gov identifier: NCT02645942, registered on 29 December 2015. Ethics: This trial has been approved by Bioethical Committee at Poznan University of Medical Sciences (approval No. 962/15) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from each patient prior to the trial.
  1 5,980 341
Cortical physiology as a therapeutic target in Parkinson's disease related dementia and cognitive dysfunction: study protocol for a randomized controlled trial
Isabelle Buard, Christine S Martin, Benzi M Kluger
July-September 2016, 1(3):91-98
DOI:10.4103/2468-5658.191351  
Background: Dementia is the leading cause of nursing home placement in Parkinson's disease (PD), yet little is known about the causes of cognitive dysfunction in PD and there are no effective treatments. Our preliminary data and other published studies suggest that abnormalities in brain activity involving networks important for normal thinking and memory may contribute to cognitive dysfunction in PD and may represent a target for treatment. Methods/Design: A randomized control trial will be conducted to assess the therapeutic potential of bifrontal repetitive transcranial magnetic stimulation (rTMS) in modulating cortical activity related to cognitive dysfunction in PD. This study will be performed at the University of Colorado Denver, Anschutz Campus, in Aurora, Colorado. Fifty-five PD patients (> 40 years of age) with mild cognitive impairment or mild dementia will be included and randomized in a 1:1 ratio to sham or real rTMS groups. Primary outcome measurement is the total score of the Mattis Dementia Rating Scale. Secondary outcome measurements are domain specific ratings of executive function, memory, language, attention, and visuospatial abilities. Discussion: If bifrontal rTMS results in positive changes to cognitive function in PD patients with mild cognitive impairment, this may represent a new and effective treatment for PD-related cognitive dysfunction. Secondly, evaluation of any bifrontal rTMS-induced changes to cognitive function will improve the current understanding of the mechanisms behind the causes of cognitive dysfunction in PD. Trial registration: Clinical Trials.gov identifier: NCT02346708; registered on 9 January 2015. Ethics: This study protocol was approved by the Colorado Multiple Institutional Review Board (COMIRB) (approval No. 13-2474) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Signed informed consent will be obtained from the patients or their guardians.
  1 6,269 467
Wirelessly programmed deep brain stimulation of the bilateral subthalamic nucleus for the treatment of primary Parkinson's disease: study protocol for a multicenter, randomized, parallel-controlled optimal-efficiency trial
Chen-cheng Zhang, Guo-dong Gao, Wei Li, Jian-min Liu, Bo-min Sun, Wei Wang, Ming Shao, Dian-you Li
July-September 2016, 1(3):107-120
DOI:10.4103/2468-5658.191353  
Background: Deep brain stimulation (DBS) is a commonly used neurosurgical approach for the debilitating motor symptoms of Parkinson's disease (PD). A number of neurostimulation products have been developed, including the Medtronic implantable neurostimulator (Medtronic USA, Inc., USA) and a wirelessly programmed implantable neurostimulator (Sceneray Co. Ltd., China) with protection by independent intellectual property rights in China. This study will validate the safety and efficacy of implantable neurostimulators in the treatment of primary PD. Methods/Design: This is a prospective, single-blind, randomized parallel-controlled optimal-efficiency trial, which will be performed in five research centers. Sixty-four patients with middle-stage and advanced-stage idiopathic PD will be randomly assigned to an experimental group and a control group according to a 1:1 ratio. An implantable neurostimulator will be implanted in each participant in both groups, but the stimulator will be activated within 1 month of surgery in the experimental group, while the patients in the control group will not receive stimulation until 3 months after implantation. After 3 months, patients in both groups will receive stimulation from the implanted neurostimulator. Beginning 6 hours after implantation, all participants will receive anti-PD drugs such as dopamine receptor agonists and compound levodopa. The primary outcome measure in this study will be changes in motor function score (Unified Parkinson's Disease Rating Scale (UPDRS)-III), relative to the baseline value, in patients from each group upon withdrawal of medications for 12 hours at 3 months after surgery. The secondary outcome measures for this study include (1) changes in UPDRS-I, II, III, and IV scores in patients from each group under the influence of medication at 3, 6, 9, and 12 months after surgery relative to baseline values; (2) changes in UPDRS-III scores upon withdrawal of medications 12 months after surgery in stimulation "on" and "off" modes relative to baseline value; (3) patient satisfaction. Safety indices are the numbers and incidences of adverse events. Discussion: This study is the first to investigate the safety and efficacy of a wirelessly programmed implantable neurostimulator enforced with protection by independent intellectual property rights in China through a randomized controlled trial. If safe and effective outcomes are acquired, this implantable neurostimulator will become a new option for treatment of PD patients. Trial registration: This trial was registered at http://www.chictr.org.cn (registration number ChiCTR-INR-16008951) on 1 August 2016. Ethics: The study protocol has been approved by the Ethics Committee of Tangdu Hospital of the Fourth Military Medical University of China (approval number: 2012009); Ethics Committee of Changhai Hospital of China (approval number: CHEC2012-044); Clinical Trial Ethics Committee, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine of China (approval number: 2012-67); Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University of China (approval number: 2012-7); Ethics Committee of First Affiliated Hospital of Guangzhou Medical University of China (approval number: 2013-8). The study protocol will be performed in strict accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from the patients or their relatives.
  - 5,915 388
Benefit of carbohydrate deficient transferrin in detecting chronic alcohol abuse in the elderly: study protocol for a multicentre, non-randomized, open-label study
Cécile Schnell
July-September 2016, 1(3):121-126
DOI:10.4103/2468-5658.191354  
Background: Alcohol misuse affects about five million people in France. Self-reported alcohol consumption, questionnaires, biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a biological marker of alcohol misuse, the specificity of the CDT is known to be superior to GGT and MCV as well. The elderly may suffer from this pathology, but its clinical and biological detection and management are often difficult, due to a frequent denial of the alcoholism and multiple chronic diseases. Methods/Design: A prospective, multicentre, non-randomized, open-label will be performed in the Geriatrics Department of the Hospital of Mulhouse, Alsace and in an Alsatian health care network. Inclusion criteria are: age ≥ 60 years, patients hospitalized for 1 day or 1 week in the Geriatrics department or new patients of the health care network, presence of a suitable relative or helper. A total of 200 enrolled patients are expected. Alcohol consumption will be detected by the Alcohol Use Disorder Identification Test - Consumption questionnaire. This questionnaire will be submitted to the patient and to a relative. If one of the two scores ≥ 1, a CDT analysis may be performed. Primary outcome is the benefit of CDT in the detection of chronic alcohol abuse in the elderly as compared with usual clinical detection tools. Secondary outcomes are sensitivity and specificity of disturbance of GGT and MCV in case of alcohol consumption and identification of socio-economic characteristics of alcohol abusers (socio-professional category, education level, way of life and environment). Discussion: Findings of this trial will probably show low sensitivity and specificity of CDT to detect chronic alcohol misuse in the elderly. Those results suggest that biological markers are not more effective than questionnaires and medical interview to detect alcohol abuse, even if the consumption is initially denied. If confirmed, the results should improve medical screening, diagnosis and care in case of alcohol abuse in the elderly and reduce costs of biological analysis. Trial registration: ClinicalTrials.gov identifier: NCT02822911, registered on 30 June 2016. Ethics: The Committee for the Protection of Persons located in Strasbourg, France, delivered a favourable opinion on the study project. Informed consent: The physician or the health network's care coordinator informs the patient about the study protocol and obtains the patient's assent. The investigator completes a non-opposition file and a copy is given to the patient and to his/her relative or helper.
  - 5,290 364
Feasibility of implantation of a cemented femoral stem in the treatment of osteoporotic femoral neck fracture in elderly patients: study protocol of a randomized controlled trial
Rong Ren, Ling-wei Li, Qi-fa Guo
July-September 2016, 1(3):127-133
DOI:10.4103/2468-5658.191355  
Background: Osteogenesis is a common problem after surgery for femoral neck fracture in elderly patients. Internal fixation for the treatment of femoral neck fracture should be performed to optimize bone remodeling and strengthen fractured bone trabeculae, with the aim of achieving strong fixation from the perspective of biomechanics. Percutaneous internal fixation with cannulated compression screws has become a preferred treatment method of osteoporotic femoral neck fracture in elderly patients, but the insufficient holding power of the screws used in the femoral neck does not lead to strong fixation. An alternative, joint prosthesis is recommended for the repair of femoral neck fracture in elderly patients. However, its long-term therapeutic effects in the treatment of osteoporotic fracture of proximal femoral neck remain poorly understood in patients with avascular necrosis of the femoral head. Methods/Design: A single-center, prospective, randomized controlled, open-label trial will be performed in Qinghai University Affiliated Hospital, Qinghai, China. One hundred patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to two groups. Group 1 will undergo percutaneous internal fixation with cannulated compression screws (n = 50) and group 2 will be implanted with cemented femoral stem (n = 50). The primary outcome measure is hip joint function evaluated by Harris hip scores taken at baseline (prior to surgery), 1, 6 and 12 months after surgery. The secondary outcome measure is hip joint pain score on a Visual Analogue Scale at baseline (prior to surgery), 1, 6 and 12 months after surgery. Other outcome measures include the percentage of patients presenting with femoral head collapse, bone non-union, sterile prosthesis loosening or peri-prosthesis infection 6 and 12 months after surgery. These will be used to evaluate the histocompatibility of biomaterial with the host tissue. Discussion: Randomized controlled studies are scarce on the long-term therapeutic effects of surgery in the treatment of osteoporotic femoral neck fracture in elderly patients presenting with avascular necrosis of the femoral head. This will be the first study to investigate the feasibility of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture complicated by avascular necrosis of the femoral head. It will test from the perspectives of safety and efficacy through a stringent randomized controlled trial based on a 12-month follow-up evaluation. Trial registration: ClinicalTrial.gov identifier: NCT02901938; registered on 12 September 2016. Ethics: This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital in China (approval number: QHY1019W) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent regarding trial procedure and treatment will be obtained from each patient or their guardians.
  - 4,752 314