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Abstract
Introduction Dementia (particularly Alzheimer’s disease, AD) is a major cause of impaired cognitive functions in the elderly. Amnestic mild cognitive impairment (aMCI) is a prodromal stage of AD, if substantiated by Alzheimer biomarkers. A neuroscientific model of pathological ageing emphasises the loss of brain plasticity, sensorimotor capacities and subsequent cognitive decline. A mechanistic treatment targeting dysfunctional plastic changes associated with ageing should be efficacious in delaying AD. In this trial, we aim to evaluate the effectiveness of a newly developed sensorimotor training, delivered at home, combined with personalised reinforcement, on the progression of aMCI-related cognitive impairments.
Methods and analysis In a randomised trial, we will compare two aMCI groups (30 subjects each), randomly allocated to a sensorimotor or a cognitive control training. Both trainings consist of an adaptive algorithm, and will last 3 months each. We hypothesise that both trainings will have positive effects on cognitive function with the sensorimotor training being superior compared with the control training based on its improvement in basic perceptual skills underlying memory encoding and retrieval. The primary outcome is episodic memory function, improved hippocampal function during memory tasks will be a secondary outcome. As further exploratory outcomes, we expect improved segregation in sensory and motor maps, better sensory discrimination only in the sensorimotor training and reduced transition to dementia (examined after completion of this study). We expect the experimental training to be evaluated more positively by the users compared with the cognitive training, resulting in reduced rates of discontinuation.
Ethics and dissemination The Ethics Committee of the Medical Faculty Mannheim, Heidelberg University, approved the study (2015–543N-MA), which adheres to the Declaration of Helsinki. The results will be published in a peer-reviewed journal. Access to raw data is available on request.
Trial registration number DRKS00012748.
- mild cognitive impairment
- dementia
- sensorimotor
- home-training
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Footnotes
Contributors HF conceived the study and obtained funding for the clinical trial. RBB, AL, SS, LF, LH, SD, DK and HF contributed to the conception and design of the study. RBB, AL and LH are involved in acquisition of data. RBB drafted the first version of the manuscript and AL, SS, LF, LH, SD, DK and HF edited and revised it and have approved its final version.
Funding This work is supported by the Reinhart Koselleck Programme of the Deutsche Forschungsgemeinschaft (FL 156/41-1). We further acknowledge financial support by the Deutsche Forschungsgemeinschaft within the funding programme Open Access Publishing, by the Baden-Württemberg Ministry of Science, Research and the Arts and by the Ruprecht-Karls-Universität Heidelberg.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The Medical Ethics Committee II of the Medical Faculty Mannheim, Heidelberg University, approved the study protocol (2015–543N-MA) which adhered to the Declaration of Helsinki in its current version.
Provenance and peer review Not commissioned; externally peer reviewed.