Neuromodulation of Cognition in Older Adults (The Stimulated Brain Study)
The Stimulated Brain Study is a Phase II randomized dose response clinical trial funded by the National Institute on Aging. The Stimulated Brain study investigates the effects of different transcranial direct current stimulation (tDCS) and cognitive training doses on cognitive function and brain health in older adults. This study not only provides critical insight into the mechanisms of tDCS and cognitive training effects, but will also determine optimal dose characteristics for maximizing the effects of the combined intervention for remediating age-related cognitive decline. Stimulated Brain will enroll 90 participants, with participants split between 3 cohorts of participants undergoing cognitive training comparing doses of active tDCS to sham tDCS. The first cohort involves 30 participants (15 active tDCS) participating in two weeks of cognitive training with daily 2mA, 20 minute tDCS delivered to the frontal lobes (F3/F4). Based on interim analyses of the initial cohort, a second cohort dose will be determined and tested in 30 new participants, with a final cohort of 30 after final interim analyses of the second cohort. Participants undergo cognitive and functional assessment and multimodal neuroimaging before intervention, after completion of intervention, and at three months post-intervention. Collectively, these data will be used to determine the direct impact of tDCS with cognitive training on functional connectivity within speed of processing and working memory networks, change in GABA and glutamate concentrations in the frontal lobes, and the impact to age-related structural changes in gray and white matter on treatment outcomes. Paired with cognitive and functional data, these data elements will provide important insight into the inner workings of tDCS and cognitive training in older adults and serve to move the field closer to clinical application.
National Institute on Aging K01AG050707