Neuromodulation of Cognition in Older Adults

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Device: Transcranial Direct Current Stimulation; Device: Sham Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02137122

5KL2TR001429 (U.S. NIH Grant/Contract)

IRB201400328-N

1K01AG050707-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

31 participants in 2 patient groups

Cognitive Training + Active tDCS

Experimental group

Description:

Participants 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.

Treatment:

Device: Transcranial Direct Current Stimulation

Cognitive Training + Sham tDCS

Sham Comparator group

Description:

Participants 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.

Treatment:

Device: Sham Stimulation