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      Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study

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          Abstract

          Background

          The possible effect of transcranial direct current stimulation (tDCS) in improving cognitive function is clear from studies involving pre-dementia stage mild cognitive impairment (MCI). However, the application of tDCS in actual clinical practice entails repeated hospital visits almost every day for treatment. The objective of this study is to confirm the possibility of self-application of tDCS at home by elderly patients with declined cognitive function and the significant clinical effect of tDCS administered at home.

          Methods/design

          This study will be conducted in 20 elderly people aged 60 to 80 years with complaints of subjective memory impairment while maintaining general functions with limited activities of daily living. This study involves a cross-over design that will include 2-week active or sham stimulation of both dorsolateral prefrontal cortexes (left, anode; right, cathode) randomly with a 2-week wash-out phase. Changes in cognitive function will be evaluated using visual recognition tasks and neuropsychological tests. In this study, tDCS will be carried out by each patient at his/her home and its safety and suitability will be evaluated.

          Discussion

          In this study, patients will apply a portable tDCS, developed for home use, for more than 2 weeks. Such studies can contribute to the use of tDCS as a realistic therapy. In addition, the utility of home-based tDCS will be confirmed by application of tDCS at home by the elderly with declined cognitive function. Furthermore, confirmation of tDCS as a significant therapeutic method can facilitate treatment of Alzheimer’s dementia at an early stage, including MCI.

          Trial registration

          Clinical Research Information Service (CRIS), KCT0002721. Registered on 9 March 2018.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-019-3360-1) contains supplementary material, which is available to authorized users.

          Related collections

          Most cited references20

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          Mild Cognitive Impairment: An Overview

          Mild cognitive impairment (MCI) refers to the transitional state between the cognitive changes of normal aging and very early dementia. MCI has generated a great deal of research from both clinical and research perspectives. Several population- and community-based studies have documented an accelerated rate of progression to dementia and Alzheimer's disease in individuals diagnosed with MCI. Clinical subtypes of MCI have been proposed to broaden the concept and include prodromal forms of a variety of dementias. An algorithm is presented to assist the clinician in identifying subjects and subclassifying them into the various types of MCI. Progression factors, including genetic, neuroimaging, biomarker, and clinical characteristics, are discussed. Neuropathological studies indicating an intermediate state between normal aging and early dementia in subjects with MCI are presented. The recently completed clinical trials as well as neuropsychological and nutritional interventions are discussed. Finally, the clinical utility of MCI, and directions for future research are proposed.
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            Prolonged visual memory enhancement after direct current stimulation in Alzheimer's disease.

            Immediately after patients with Alzheimer's disease (AD) receive a single anodal transcranial direct current stimulation (tDCS) session their memory performance improves. Whether multiple tDCS sessions improve memory performance in the longer term remains unclear. In this study we aimed to assess memory changes after five consecutive sessions of anodal tDCS applied over the temporal cortex in patients with AD. A total of 15 patients were enrolled in two centers. Cognitive functions were evaluated before and after therapeutic tDCS. tDCS was delivered bilaterally through two scalp anodal electrodes placed over the temporal regions and a reference electrode over the right deltoid muscle. The stimulating current was set at 2 mA intensity and was delivered for 30 minutes per day for 5 consecutive days. After patients received tDCS, their performance in a visual recognition memory test significantly improved. We found a main effect of tDCS on memory performance, i.e., anodal stimulation improved it by 8.99% from baseline, whereas sham stimulation decreased it by 2.62%. tDCS failed to influence differentially general cognitive performance measures or a visual attention measure. Our findings show that after patients with AD receive anodal tDCS over the temporal cerebral cortex in five consecutive daily sessions their visual recognition memory improves and the improvement persists for at least 4 weeks after therapy. These encouraging results provide additional support for continuing to investigate anodal tDCS as an adjuvant treatment for patients with AD. Copyright © 2012 Elsevier Inc. All rights reserved.
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              Temporal cortex direct current stimulation enhances performance on a visual recognition memory task in Alzheimer disease.

              Several studies have reported that transcranial direct current stimulation (tDCS), a non-invasive method of neuromodulation, enhances some aspects of working memory in healthy and Parkinson disease subjects. The aim of this study was to investigate the impact of anodal tDCS on recognition memory, working memory and selective attention in Alzheimer disease (AD). Ten patients with diagnosis of AD received three sessions of anodal tDCS (left dorsolateral prefrontal cortex, left temporal cortex and sham stimulation) with an intensity of 2 mA for 30 min. Sessions were performed in different days in a randomised order. The following tests were assessed during stimulation: Stroop, Digit Span and a Visual Recognition Memory task (VRM). The results showed a significant effect of stimulation condition on VRM (p = 0.0085), and post hoc analysis showed an improvement after temporal (p = 0.01) and prefrontal (p = 0.01) tDCS as compared with sham stimulation. There were no significant changes in attention as indexed by Stroop task performance. As far as is known, this is the first trial showing that tDCS can enhance a component of recognition memory. The potential mechanisms of action and the implications of these results are discussed.

                Author and article information

                Contributors
                seob0115@gmail.com
                shade9074@naver.com
                chungkyungmi@yuhs.ac
                PREPPIE@yuhs.ac
                COKIM@yuhs.ac
                +82-2-2019-3341 , empathy@yuhs.ac
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                21 May 2019
                21 May 2019
                2019
                : 20
                : 278
                Affiliations
                [1 ]ISNI 0000 0004 0647 2391, GRID grid.416665.6, Department of Psychiatry, , National Health Insurance Service Ilsan Hospital, ; Goyang, South Korea
                [2 ]ISNI 0000 0004 0647 8021, GRID grid.459553.b, Department of Psychiatry, , Gangnam Severance Hospital, Yonsei University Health System, ; 211 Eonju-ro, Gangnam-gu, Seoul, 06273 South Korea
                [3 ]ISNI 0000 0004 0470 5454, GRID grid.15444.30, Department of Psychiatry and Institute of Behavioral Science in Medicine, , Yonsei University College of Medicine, ; Seoul, South Korea
                [4 ]ISNI 0000 0004 0470 5454, GRID grid.15444.30, Division of Geriatrics, Department of Internal Medicine, , Severance Hospital, Yonsei University College of Medicine, ; Seoul, South Korea
                Article
                3360
                10.1186/s13063-019-3360-1
                6528356
                31113459
                3de7b7d4-2f78-45a3-8c4a-4f9be396eae9
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 26 March 2018
                : 15 April 2019
                Funding
                Funded by: Korea Health Industry Development Institute (KR)
                Award ID: HI17C1934
                Funded by: FundRef http://dx.doi.org/10.13039/501100003725, National Research Foundation of Korea;
                Award ID: 2016R1C1B2010739
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100003625, Ministry of Health and Welfare;
                Award ID: HM15C0995
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100008005, Yonsei University College of Medicine;
                Award ID: 6-2015-0174
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

                Medicine
                transcranial direct current stimulation,mild cognitive impairment,home-based,cross-over study,brain stimulation

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