Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03723850
Other study ID # IRB18-1246
Secondary ID R21AG060444
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2019
Est. completion date December 15, 2022

Study information

Verified date April 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts memory performance as a function of time-of-day in younger and older adults.


Description:

Transcranial Direct Current Stimulation (tDCS) is the safest and most accessible, non-invasive brain stimulation technique available for testing causal links between different brain regions and functions, by manipulating cognitive abilities. By identifying key experimental factors that can improve the reliability and robustness of stimulation effects on cognitive performance in different age groups, this project should lead to the widespread adoption of these design features in future applications. This study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts recollection accuracy and working memory performance as a function of time-of-day in younger and older adults. Moreover, this study will test the extent that tDCS to dlPFC impacts memory performance by impacting information-specific processes and/or cognitive control processes that operate across different types of information, thereby informing basic theories of how dlPFC contributes to memory in younger and older adults.


Recruitment information / eligibility

Status Completed
Enrollment 271
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Right-handed (according to the Edinburgh Handedness Inventory) - Normal or corrected vision - Fluent in English (started learning by age 6) - Ability to understand and provide informed consent for study procedures, and to comply - with study procedures for the entire length of the study. - For individuals in the 'younger adults' group, must be between 18 and 30 years of age - For individuals in the 'older adults' group, must be between 60 and 75 years of age - A score of 23 or above on the Montreal Cognitive Assessment (out of 30, education-corrected) is required. This is to minimize the inclusion of suspected mild cognitive impairment (MCI) or dementia, targeting individuals that score in the normal range according to the recent meta-analysis of MoCA's ability to differentiate normal aging from MCI in Carson et al. (2018, Int. J of Geriatric Psychiatry). - Performance above threshold on the episodic memory task during the baseline session. The threshold is defined as having a hit rate that is at least 5% greater than the false alarm rate, where hit rate is defined as the number of studied items identified as studied, divided by the total number of studied items, and false alarm rate is defined as the number of new items identified as studied, divided by the total number of new items. We don't anticipate this threshold to exclude many, if any subjects. Exclusion Criteria: - Neuropsychological conditions associated with cognitive decline or seizure - Cochlear implants or metal in the brain/skull (except titanium) - Psychoactive medications, or diagnosis of depression, bipolar disorder, or any psychotic diagnoses - History of excessive use (clinically treated) alcohol or narcotics - Hospitalization for head trauma (e.g. concussions) in the past 5 years - Individuals above a threshold score on an assessment of depression, specifically, a score of 10 or above on the Patient Health Questionnaire (PHQ-9)(Manea et al., 2012) - Risk of pregnancy - Low tolerance of skin irritation - Prior brain stimulation experience (self-report) - Ongoing cognitive or sensory deficits/symptoms from a previous (or current) COVID-19 infection.

Study Design


Related Conditions & MeSH terms

  • Effect of tDCS on Memory in Older and Younger Adults

Intervention

Device:
Active tDCS
The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
Sham tDCS
The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Episodic Memory Performance To measure episodic memory performance, participants will perform a recollection task. They will first study picture and word stimuli (encoding phase). On the subsequent memory test (retrieval phase), participants will be asked to differentiate between studied and non-studied items, as well as recollecting the previous format for studied items (i.e. recollecting the picture or word). For each tested item, participants will also be asked to make a confidence judgement about their response. The primary dependent variable (DV) will be the proportion of studied items attributed to the correct source minus the proportion of nonstudied items incorrectly attributed to that same source. This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.
Secondary Working Memory Performance To measure working memory performance, participants will perform two versions of the N-back task -- a verbal version (i.e., presenting the numbers 1-9 in a varied sequence) and a visuospatial version (i.e., presenting a colored square in one of 9 locations on a 3x3 grid in a varied sequence). The primary DV will be working memory accuracy: proportion of targets correctly identified minus the proportion of lures incorrectly endorsed. This task lasts approximately 10 minutes and is performed immediately after the episodic memory task (approximately 20 minutes after the end of the tDCS session).