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

NCT03723850 | Completed Results DMC FDA Device

• 2 other identifiers: IRB18-1246R21AG060444
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of tDCS on Memory in Older and Younger Adults

Keywords

Transcranial Direct Current Stimulation; Memory; Prefrontal Cortex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Working Memory Performance

  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).

Study Arms (5)

Older, active tDCS, dlPFC

EXPERIMENTAL

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

Older, sham tDCS, dlPFC

SHAM COMPARATOR

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

Younger, active tDCS, dlPFC

EXPERIMENTAL

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

Younger, sham tDCS, dlPFC/parietal

SHAM COMPARATOR

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

Younger, active tDCS, parietal cortex

ACTIVE COMPARATOR

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

Interventions

Active tDCS DEVICE

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.

Older, active tDCS, dlPFC; Younger, active tDCS, dlPFC; Younger, active tDCS, parietal cortex

Sham tDCS DEVICE

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.

Older, sham tDCS, dlPFC; Younger, sham tDCS, dlPFC/parietal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Results Point of Contact

• Title: Dr. David Gallo
• Organization: University of Chicago

dgallo@uchicago.edu

773-702-8829

Study Officials

• David Galllo

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participant, nor the research assistant administering tDCS will know if the participant is receiving active tDCS or sham tDCS.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: March 8, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)