HealthyFOKhintNCT03693729
Effects of Brain-stimulation on Metamemory Monitoring and Control
A study testing HD-tDCS in people with Healthy, run by Brooklyn College of the City University of New York at 1 site in United States.
Trial summary
When people learn and remember information, it is often accompanied by a feeling of subjective confidence about whether or not information has been learned and accurately remembered. These subjective feelings of confidence are often related to actual memory performance, but are sometimes incorrect. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, right-handed adults ages 18-35. English spoken since age 5. Normal or corrected-to-normal vision.
Who cannot join
- Participants will be excluded if they have chronic skin disease or a medical skin condition, or an unhealed open wound on the scalp, face, neck, or forehead near the electrode location.
- Participants will be excluded if they self-report significant medical, neurological, or psychiatric illness and/or a history of substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Brain-stimulation on Memory and Memory Awareness
When people learn and remember information, it is often accompanied by a feeling of subjective confidence about whether or not information has been learned and accurately remembered. These subjective feelings of confidence are often related to actual memory performance, but are sometimes incorrect. The investigators have previously shown that applying high definition transcranial direct current stimulation (HD-tDCS) over the dorsolateral prefrontal cortex leads to more accurate feelings of subjective confidence, at least when subjects are asked for their confidence about future memory performance. Accurate confidence judgments are useful in that they may later subsequent behavior, and inaccurate ones may be costly. For example, a student who erroneously believes that studied material was learned may stop studying and not do well on a test. Individuals who have a feeling-of-knowing about the answer to a general knowledge question will continue to search their memory, whereas individuals who do not have a feeling-of-knowing will stop searching their memory. Individuals who are confident they know the answer to a question are more likely to answer it. In this study, the experimenters are testing the effects of brain stimulation on subjective awareness of memory (termed metamemory monitoring) and how people use those subjective judgments (termed metamemory control). The approach taken is to have participants visit the laboratory on 3 visits and receive brain stimulation while completing memory and metamemory tasks.
- Conditions
- Healthy
- Being tested
- HD-tDCS
- Keywords
- memory, metacognition, metamemory, transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCSDevice
Also called Behavioral
Participants will complete a metamemory and memory task
| Study group | Role | What they receive |
|---|---|---|
| Active DLPFC during task | Experimental | HD-tDCS will be applied over the DLPFC at 2mA in a single session for up to 30 min during the memory and metamemory task Receives: Device: HD-tDCS |
| Active DLPFC after task | Active comparator | HD-tDCS will be applied over the DLPFC at 2mA in a single session for up to 30 min after the memory and metamemory task and during a filler task. Receives: Device: HD-tDCS |
| Sham DLPFC during task | Sham comparator | Sham HD-tDCS will be applied over the DLPFC at 2mA in a single session for up to 30 min during the memory and metamemory task Receives: Device: HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory Control Advantage Index
This indexes the memory advantage for choosing which general knowledge question one receives a hint about the answer to versus having the experimenter choose which general knowledge question one receives a hint about the answer. The investigators will subtract the proportion of correctly recognized general knowledge answers for experimenter-chosen questions from the proportion correctly recognized for participant-chosen questions
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (3)
semantic recognition as assessed by a general knowledge task
Differences in recognition are compared between each condition (each active HD-tDCS and sham).
Measured: Through study completion, an average of 3 weeks
semantic recall as assessed by a general knowledge task
Differences in recall are compared between each condition (each active HD-tDCS and sham).
Measured: Through study completion, an average of 3 weeks
Feeling-of-knowing ratings and their accuracy
Feeling of knowing ratings are given on a scale. To assess the accuracy of these ratings, the subjective ratings are compared to objective accuracy, using signal detection based measures. Differences in feeling-of-knowing ratings and their accuracy are compared between each condition (each active HD-tDCS and sham).
Measured: Through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start3 Sep 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooklyn College of the City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Elizabeth Chua, Brooklyn College of the City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693729
- Sponsor's protocol ID
- BrooklynC
- Other IDs
- SC3GM121192
- Acronym
- FOKhint
- Status last verified
- Jul 2020
- First submitted
- 21 Sep 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brain-stimulation on Memory and Memory Awareness
- ClinicalTrials.gov ID
- NCT03693729
- Acronym / sponsor ID
- FOKhint / BrooklynC
- Conditions
- Healthy
- Keywords
- memory, metacognition, metamemory, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Brooklyn College of the City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When people learn and remember information, it is often accompanied by a feeling of subjective confidence about whether or not information has been learned and accurately remembered. These subjective feelings of confidence are often related to actual memory performance, but are sometimes incorrect. The investigators have previously shown that applying high definition transcranial direct current stimulation (HD-tDCS) over the dorsolateral prefrontal cortex leads to more accurate feelings of subjective confidence, at least when subjects are asked for their confidence about future memory performance. Accurate confidence judgments are useful in that they may later subsequent behavior, and inaccurate ones may be costly. For example, a student who erroneously believes that studied material was learned may stop studying and not do well on a test. Individuals who have a feeling-of-knowing about the answer to a general knowledge question will continue to search their memory, whereas individuals who do not have a feeling-of-knowing will stop searching their memory. Individuals who are confident they know the answer to a question are more likely to answer it. In this study, the experimenters are testing the effects of brain stimulation on subjective awareness of memory (termed metamemory monitoring) and how people use those subjective judgments (termed metamemory control). The approach taken is to have participants visit the laboratory on 3 visits and receive brain stimulation while completing memory and metamemory tasks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active DLPFC during task | Experimental | Device: HD-tDCSHD-tDCS will be applied over the DLPFC at 2mA in a single session for up to 30 min during the memory and metamemory task |
| Active DLPFC after task | Active comparator | Device: HD-tDCSHD-tDCS will be applied over the DLPFC at 2mA in a single session for up to 30 min after the memory and metamemory task and during a filler task. |
| Sham DLPFC during task | Sham comparator | Device: HD-tDCSSham HD-tDCS will be applied over the DLPFC at 2mA in a single session for up to 30 min during the memory and metamemory task |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, right-handed adults ages 18-35. English spoken since age 5. Normal or corrected-to-normal vision.
Key exclusion criteria (2 listed)
- Participants will be excluded if they have chronic skin disease or a medical skin condition, or an unhealed open wound on the scalp, face, neck, or forehead near the electrode location.
- Participants will be excluded if they self-report significant medical, neurological, or psychiatric illness and/or a history of substance abuse
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 |
|---|---|---|
| HD-tDCSAlso: BehavioralParticipants will complete a metamemory and memory task | Device | Active DLPFC after task, Active DLPFC during task, Sham DLPFC during task |
Primary outcome
Memory Control Advantage Index
Time frame: Through study completion, an average of 3 weeks
This indexes the memory advantage for choosing which general knowledge question one receives a hint about the answer to versus having the experimenter choose which general knowledge question one receives a hint about the answer. The investigators will subtract the proportion of correctly recognized general knowledge answers for experimenter-chosen questions from the proportion correctly recognized for participant-chosen questions
3 secondary outcomes
semantic recognition as assessed by a general knowledge task
Time frame: Through study completion, an average of 3 weeks
semantic recall as assessed by a general knowledge task
Time frame: Through study completion, an average of 3 weeks
Feeling-of-knowing ratings and their accuracy
Time frame: Through study completion, an average of 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS in people with Healthy, run by Brooklyn College of the City University of New York 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Jul 2020. 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?
Results are not available in the source record.
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?
Memory Control Advantage Index (time frame: Through study completion, an average of 3 weeks). 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 10 Jul 2020.