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

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.

Reliability, sensitivity, and predictive value of fMRI during multiple object tracking as a marker of cognitive training gain in combination with tDCS in stroke survivors

“…Beyond robust improvement on all trained tasks during the course of the intervention, our results provide no evidence of additional beneficial effects of tDCS stimulation. Intriguingly, current investigations aim to evaluate how home‐based tDCS may aid patients with mild cognitive impairments (Park et al, 2019). This will potentially provide novel insights regarding clinical application for tDCS.…”

Reliability, sensitivity and predictive value of fMRI during multiple object tracking as a marker of cognitive training gain in combination with tDCS in stroke survivors

“…Beyond robust improvement on all trained tasks during the course of the intervention, our results provide no evidence of additional beneficial effects of tDCS stimulation. Intriguingly, current investigations aim to evaluate how home-based tDCS may aid patients with mild cognitive impairments (Park et al, 2019). This will potentially provide novel insights regarding clinical application for tDCS.…”

“…Specifically, we estimated activation patterns during multiple object tracking (MOT) at baseline, before initiating training (on average 4 weeks after baseline measure), and after a three-week intervention. The multiple object tracking (MOT) task offers a promising tool for assessing and manipulate converging activation patterns across attention and working memory tasks in both healthy controls and stroke patients Pylyshyn and Strom, 1988;Walle et al, 2019). MOT robustly recruit brain areas comparable with activations associated with Cogmed training (Olesen et al, 2004), including canonical task-positive and task-negative brain networks.…”

Transcranial Direct Current Stimulation and Cognition in Neuropsychiatric Disorders: Systematic Review of the Evidence and Future Directions

“…Additionally, in crossover trials the absence of a sufficient wash-out period, as to prevent carry-over effects, impeded the objective evaluation of outcomes measured after the second treatment period. Given that the effect of tDCS may persist several days after stimulation (Gálvez and others 2013; Khedr and others 2014; Park and others 2019), we considered as an appropriate wash-out period a 2-week interval, and deemed as unbiased only crossover trials where wash-out was properly performed. Thirty-seven percent of studies raised some concerns pertaining to the randomization process (i.e., no information about concealment of the allocation sequence) (Boggio and others 2012; Brunoni and others 2014; Fregni and others 2006; Loo and others 2010; Reinhart and others 2015a; Roncero and others 2017; Schwippel and others 2018), unclear effect of assignment to intervention (i.e.…”