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Effect of Noninvasive Electrical Brain Stimulation on Memory Performance at Different Times of Day in Younger and Older Adults

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ClinicalTrials.gov Identifier: NCT03723850
Recruitment Status : Not yet recruiting
First Posted : October 30, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Effect of tDCS on Memory in Older and Younger Adults Device: Active tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Neither the participant, nor the research assistant administering tDCS will know if the participant is receiving active tDCS or sham tDCS.
Primary Purpose: Basic Science
Official Title: Effect of Noninvasive Electrical Brain Stimulation on Memory Performance at Different Times of Day in Younger and Older Adults
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Older, active tDCS, dlPFC

Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).

2.

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 Comparator: Older, sham tDCS, dlPFC
Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Device: 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.

Experimental: Younger, active tDCS, dlPFC
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
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 Comparator: Younger, sham tDCS, dlPFC/parietal
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
Device: 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.

Active Comparator: Younger, active tDCS, parietal cortex
Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).
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.




Primary Outcome Measures :
  1. Episodic memory performance [ Time Frame: This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes. ]
    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 recollection accuracy: the proportion of correctly recollected studied items minus the non-studied item baseline.


Secondary Outcome Measures :
  1. Working memory performance [ Time Frame: 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). ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723850


Contacts
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Contact: Taylor Chamberlain 4438400043 tchamberlain@uchicago.edu
Contact: Gabriella Hirsch 805-570-9165 gvhirsch@uchicago.edu

Sponsors and Collaborators
University of Chicago
National Institute on Aging (NIA)
Investigators
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Principal Investigator: David Galllo University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03723850     History of Changes
Other Study ID Numbers: IRB18-1246
R21AG060444 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will post data on the Open Science Framework (online), so that de-identified data will be made available to any outside researcher. Shared data will include, at a minimum, an excel data file used to summarize all participant cognitive data. Any computer scripts or stimuli used for task development also will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Study data will become available within 6 months of publication of the relevant results.
Access Criteria: The investigators will use the Open Science Framework for making data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Chicago:
Transcranial Direct Current Stimulation
Memory
Prefrontal Cortex