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Abstract Introduction Given rapid global population aging, developing interventions against age‐associated cognitive decline is an important medical and societal goal. We evaluated a cognitive training protocol combined with transcranial direct current stimulation (tDCS) on trained and non‐trained functions in non‐demented older adults. Methods Fifty‐six older adults (65–80 years) were randomly assigned to one of two interventional groups, using age and baseline performance as strata. Both groups performed a nine‐session cognitive training over 3 weeks with either concurrent anodal tDCS (atDCS, 1 mA, 20 minutes) over the left dorsolateral prefrontal cortex (target intervention) or sham stimulation (control intervention). Primary outcome was performance on the trained letter updating task immediately after training. Secondary outcomes included performance on other executive and memory (near and far transfer) tasks. All tasks were administered at baseline, post‐intervention, and at 1‐ and 7‐month follow‐up assessments. Prespecified analyses to investigate treatment effects were conducted using mixed‐model analyses. Results No between‐group differences emerged in the trained letter updating and Markov decision‐making tasks at post‐intervention and at follow‐up timepoints. Secondary analyses revealed group differences in one near‐transfer task: Superior n‐back task performance was observed in the tDCS group at post‐intervention and at follow‐up. No such effects were observed for the other transfer tasks. Improvements in working memory were associated with individually induced electric field strengths. Discussion Cognitive training with atDCS did not lead to superior improvement in trained task performance compared to cognitive training with sham stimulation. Thus, our results do not support the immediate benefit of tDCS‐assisted multi‐session cognitive training on the trained function. As the intervention enhanced performance in a near‐transfer working memory task, we provide exploratory evidence for effects on non‐trained working memory functions in non‐demented older adults that persist over a period of 1 month.

BackgroundWith increasing aging populations worldwide, developing interventions against age-associated cognitive decline is particularly important. Evidence suggests that combination of brain stimulation with cognitive training intervention may enhance training effects in terms of performance gain or transfer to untrained domains. This protocol describes a Phase IIb clinical trial that investigates the intervention effects of training combined with brain stimulation in older adults.MethodsThe TrainStim-Cog study is a monocentric, randomized, single-blind, placebo-controlled intervention. The study will investigate cognitive training with concurrent anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (target intervention) compared to cognitive training with sham stimulation (control intervention) over nine sessions in 3 weeks, consisting of a letter updating task, and a three-stage Markov decision-making task. Fifty-six older adults will be recruited from the general population. Baseline assessment will be performed including neuropsychological screening and performance on training tasks. Participants will be allocated to one of the two study arms using block-wise randomization stratified by age and baseline performance with a 1:1 allocation ratio. Primary outcome is performance in the letter updating task after training under anodal tDCS compared to sham stimulation. Secondary outcomes include performance changes in the decision-making task and transfer tasks, as well as brain structure and functional networks assessed by structural, and functional magnetic resonance imaging (MRI) that are acquired pre- and post-intervention.SignificanceThe main aim of the TrainStim-Cog study is to provide evidence for behavioral and neuronal effects of tDCS-accompanied cognitive training and to elucidate the underlying mechanisms in older adults. Our findings will contribute toward developing efficient interventions for age-associated cognitive decline.Trial registrationThis trial was retrospectively registered at Clinicaltrials.gov Identifier: NCT03838211 at February 12, 2019, https://clinicaltrials.gov/ct2/show/NCT03838211.Protocol versionBased on BB 004/18 version 1.2 (May 17, 2019).