Clinical trial NCT03723850: Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults
Official title: Effect of Noninvasive Electrical Brain Stimulation on Memory Performance at Different Times of Day in Younger and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of tDCS on Memory in Older and Younger Adults
Keywords: Transcranial Direct Current Stimulation
Memory
Prefrontal Cortex
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-10-30
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Episodic Memory Performance
timeFrame: This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.
Secondary outcomes:
measure: Working Memory Performance
timeFrame: 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).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: David Galllo
role: PRINCIPAL_INVESTIGATOR
References: