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Neuromodulation of Cognition in Older Adults

Not Applicable
Completed
Conditions
Healthy
Interventions
Device: Sham Stimulation
Device: Transcranial Direct Current Stimulation
Registration Number
NCT02137122
Lead Sponsor
University of Florida
Brief Summary

This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.

Detailed Description

The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
Inclusion Criteria
  • Men and women
  • Age: 65 to 90 years
  • English speaking
  • Physically mobile
  • working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.
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Exclusion Criteria
  • Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
  • Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
  • Past opportunistic brain infection.
  • Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality).
  • Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
  • MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
  • Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
  • Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
  • Hearing or vision deficits that will not allow for standardized cognitive training.
  • Left handedness
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cognitive Training + Sham tDCSSham StimulationParticipants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation.
Cognitive Training + Active tDCSTranscranial Direct Current StimulationParticipants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation.
Primary Outcome Measures
NameTimeMethod
Change in NIH Toolbox Fluid Cognition Composite Scorebaseline up to two week post test

The NIH Toolbox is a battery of neurocognitive tests created by the National Institute on Aging as a comprehensive measure of cognitive function. We used the change from baseline to two week post test in the NIH Toolbox Fluid Cognition Composite Score (FCC) to assess outcome. The uncorrected standard score of the FCC was used. The FCC is derived by averaging the standard scores of the NIH Toolbox Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting, and Pattern Comparison tests and then deriving standard scores based on this new distribution. The uncorrected standard score is on a scale of mean = 100, standard deviation = 15. Higher positive scores mean a greater improvement at the post test. Difference scores ranged from a minimum of -7 to a maximum of 19. FCC scores ranged from a minimum of 73 to a maximum of 112 in this sample. On a population level percentiles are reported from a minimum score of 59 to a maximum of 140, covering 99.3% of the population.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

University of Florida

🇺🇸

Gainesville, Florida, United States

McKnight Brain Institute

🇺🇸

Gainesville, Florida, United States

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