Effect of tDCS on Memory in Older and Younger AdultsNCT03723850
Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults
A study testing Active tDCS in people with Effect of tDCS on Memory in Older and Younger Adults, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of tDCS on Memory in Older and Younger Adults
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Noninvasive Electrical Brain Stimulation on Memory Performance at Different Times of Day in Younger and Older Adults
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.
Read the 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.
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Transcranial Direct Current Stimulation, Memory, Prefrontal Cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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 tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Device: Active tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.
Secondary outcomes (1)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start8 Mar 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Effect of tDCS on Memory in Older and Younger AdultsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- David Galllo, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723850
- Sponsor's protocol ID
- IRB18-1246
- Other IDs
- R21AG060444
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2018
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noninvasive Electrical Brain Stimulation on Memory Performance at Different Times of Day in Younger and Older Adults
- ClinicalTrials.gov ID
- NCT03723850
- Acronym / sponsor ID
- IRB18-1246
- Keywords
- Transcranial Direct Current Stimulation, Memory, Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Older, active tDCS, dlPFC | Experimental | Device: Active tDCSOlder 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. |
| Older, sham tDCS, dlPFC | Sham comparator | Device: Sham tDCSOlder 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). |
| Younger, active tDCS, dlPFC | Experimental | Device: Active tDCSYounger 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). |
| Younger, sham tDCS, dlPFC/parietal | Sham comparator | Device: Sham tDCSYounger 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). |
| Younger, active tDCS, parietal cortex | Active comparator | Device: Active tDCSYounger 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSThe 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. | Device | Older, active tDCS, dlPFC, Younger, active tDCS, dlPFC, Younger, active tDCS, parietal cortex |
| Sham tDCSThe 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. | Device | Older, sham tDCS, dlPFC, Younger, sham tDCS, dlPFC/parietal |
Primary outcome
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 the proportion of studied items attributed to the correct source minus the proportion of nonstudied items incorrectly attributed to that same source.
1 secondary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Galllo principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Effect of tDCS on Memory in Older and Younger Adults, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodic Memory Performance (time frame: This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.