Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial
Emma Gulley, Joe Verghese, Helena M Blumen, Emmeline Ayers, Cuiling Wang, Russell K Portenoy, Jessica L Zwerling, Erica Weiss, Helena Knotkova, Emma Gulley, Joe Verghese, Helena M Blumen, Emmeline Ayers, Cuiling Wang, Russell K Portenoy, Jessica L Zwerling, Erica Weiss, Helena Knotkova
Abstract
New therapies for symptoms in Alzheimer's disease (AD) are urgently needed. Prior studies suggest that transcranial direct current stimulation (tDCS), a noninvasive neuromodulatory method, may be a safe and potentially effective treatment, but conclusions have been limited by small-sample sizes and brief stimulation protocols. This double-blind randomized trial involving 100 older adults with mild-to-moderate AD examines effects of 6 months of at-home active tDCS or sham delivered over the dorsolateral prefrontal cortex. The primary outcome is global cognitive performance. Secondary outcomes include executive-control/spatial selective attention, functional neuroplasticity, depressive symptoms, quality of life and the durability of effects 3 months after the stimulation period. The results will provide evidence on the efficacy of multimonth at-home tDCS in the AD treatment. =Clinical trial identifier NCT04404153 (Clinicaltrials.gov).
Keywords: Alzheimer’s disease; at-home tDCS; clinical trial protocol; dementia; noninvasive neurostimulation; transcranial direct current stimulation (tDCS).
Conflict of interest statement
Financial & competing interests disclosure
This work is supported by a grant from the National Institutes of Health (1 R01 AG068167-01). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Source: PubMed