Augmenting Cognitive Training In Older Adults

Summary

A two-phase adaptive 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 could enhance neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance neurocognitive function, brain function, and functional outcomes from CT, with combined CT and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12 months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs. active cognitive tasks will predict individual response to tDCS.

Conditions

• Aging

Interventions

BEHAVIORAL

Cognitive Training

Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.

DEVICE

tDCS (active stimulation)

A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).

DEVICE

tDCS (sham stimulation)

Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.

BEHAVIORAL

Educational Training

Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.

Sponsors & Collaborators

• University of Arizona

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Adam Woods, Ph.D · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-08

Primary Completion

2022-04-30

Completion

2022-04-30

FDA Device

Yes

Countries

• United States

Study Locations