CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 379 enrolled
Drug / intervention
Cognitive Training +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02851511
NCT02851511N/ACompleted

Augmenting Cognitive Training In Older Adults

University of Florida·interventional·Posted Aug 1, 2016·Updated Apr 17, 2024

In Brief

A clinical study evaluating Cognitive Training, tDCS (active stimulation), and 2 other interventions for Aging. Completed, enrolled 379 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAging
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 1, 2016
Enrollment StartAug 8, 2017
Primary CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.9 years ago

Interventions

Cognitive Trainingbehavioral

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

tDCS (active stimulation)device

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).

tDCS (sham stimulation)device

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.

Educational Trainingbehavioral

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.