Brain-IT: Targeting the Brain using Information Technology for Secondary Prevention of mild Neurocognitive Disorder

Abstract

Introduction: Effective interventions to mitigate one of the key challenges for aging societies, neurocognitive disorders, are urgently needed. A collaborative international guideline recently recommended physical exercise (PE) for secondary prevention of mild neurocognitive disorder (mNCD). Physical exercises that integrate cognitive exercises and are combined with resonance breathing guided by heart rate variability biofeedback (HRV-BF) target various relevant mechanisms of action to alleviate the pathological state in mNCD. However, this novel intervention approach has not yet been investigated. Methods: We systematically designed, developed, and evaluated a novel training concept (called ‘Brain-IT’) specifically for older adults with mNCD that implements this novel intervention approach. The projects’ methodology followed the guidelines of the Medical Research Council for the development and evaluation of complex interventions as well as the Multidisciplinary Iterative Design of Exergames (MIDE) - Framework. Primary end users (individuals with mNCD), secondary end users (physiotherapists, occupational therapists, healthcare professionals), exergaming researchers, as well as experts from the exergaming industry were continuously involved to facilitate the acceptance and transfer of the resulting training concept into clinical practice. Results: In the first phase of the project, we successfully determined a set of design requirements for the 'Brain-IT' training concept in collaboration with 10 experts and 8 individuals with mNCD. This set of design requirements formed the basis for phase 2, where a first prototype of the 'Brain-IT' training concept was co-designed and developed. We iteratively tested and refined this prototype until we achieved an "acceptable" (= feasible, usable, safe, and well accepted) solution. In the final randomized controlled trial (RCT), we observed statistically significant effects with large effect sizes for global cognitive performance, immediate verbal recall, and delayed verbal recall in favor of the intervention group. 55 % of participants showed a clinically relevant improvement in global cognitive functioning in response to training. The remaining (underpowered) statistical analyses revealed no significant effects, but favorable changes in descriptive statistics with small to moderate effects in favor of the intervention group, particularly with regards to quality of life. Conclusion: Our rigorous methodological approach resulted in a user-centered, personalized, and highly innovative training concept. Notably, we revealed, to the best of our knowledge, as the first research team, that this novel intervention approach of combining exergame training with biofeedback-guided resonance breathing is not only safe, feasible, and highly accepted by individuals with mNCD, but also highly effective in improving cognitive performance. Confirmatory RCTs are warranted to (i) be able to conclude about potential near- and far-transfer effects of the training; (ii) investigate whether the observed improvements in cognitive performance translate to affecting the rates of progression to or onset of dementia; (iii) test the implementation of the training in clinical practice; and (iv) elucidate the underlying biological mechanisms of action.