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A randomized two-phase clinical trial will enroll 360 participants with age-related cognitive decline, but not Alzheimer's disease or other neurodegenerative diseases (MoCA>25). Cognitively healthy elderly adults will undergo a CT intervention or education training-control (TC) condition in combination with transcranial direct current stimulation (tDCS) or sham tDCS control. The CT intervention will employ a suite of adaptive training tasks (Double Decision - Useful Field of View, Card Shark - Working Memory, and Freeze Frame - Arousal-Alerting) from the POSIT Science Brain HQ6, a well validated CT method for enhancing cognitive functioning in the elderly. TC will involve exposure to educational nature videos and related content questions of the same interval and duration as CT, providing a well-matched active control. Participants will receive CT or TC in conjunction with tDCS or sham/placebo prefrontal stimulation administered during training. Participants will be assessed at baseline, after CT (12 weeks), and at 12-month follow-up. At each time point, a comprehensive neurocognitive, clinical and multimodal neuroimaging assessment of brain function, metabolic state, and brain structure will be conducted. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention and memory encoding. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites and gamma-aminobutyric acid (GABA) concentrations. GABA concentrations from MRS will provide a sensitive marker of neuro-plastic change in task-associated brain regions. Alzheimer's disease risk factors (APOE4, familial history), baseline clinical/demographic characteristics (e.g., diabetes), and neuroimaging biomarkers (e.g., white matter abnormality load) will assess factors with predictive value for individual response to tDCS and CT. Based on power analyses of intervention effects, 80 participants will be randomized to the four treatment conditions in phase 1. Following the intervention, CT (n=40) and TC (n=40) conditions will be compared. Interim analyses aimed at showing that CT has previously established strong effects on cognitive outcomes will be performed, thereby enabling elimination of the TC condition. Phase 2 will enroll the remaining 280 participants into the two CT intervention conditions.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cognitive Training, tDCS (active stimulation), tDCS (sham stimulation), Educational Training
University of Florida Institute on Aging
Not yet recruiting
University of Florida
Published on BioPortfolio: 2016-08-02T05:53:24-0400
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Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.
Stimulation at an intensity below that where a differentiated response can be elicited.
The electrical response evoked in a muscle or motor nerve by electrical or magnetic stimulation. Common methods of stimulation are by transcranial electrical and TRANSCRANIAL MAGNETIC STIMULATION. It is often used for monitoring during neurosurgery.
A technique of brain electric stimulation therapy which uses constant, low current delivered via ELECTRODES placed on various locations on the scalp.
The electric response evoked in the CEREBRAL CORTEX by ACOUSTIC STIMULATION or stimulation of the AUDITORY PATHWAYS.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...