Investigating the Neural Correlates in Memory Retrieval After HD-tDCS

August 24, 2020 updated by: Sven Vanneste, The University of Texas at Dallas

The overall objective of this study is to investigate the neural correlate in retrieval memory task.

The aim of the study is to understand the undergoing changes in late positive ERP component during retrieval memory task when stimulating the posterior cingulate cortex (PCC) with High Definition Transcranial Direct Current Stimulation (HD-tDCS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Retrieval memory is supported by distinct retrieval process known as recollection and familiarity. These two process have been associated with distinct event related potentials (ERPs). At the time of retrieval, familiarity is associated with modulation of the FN400, an enhanced positivity for old items relative to new items observed from approximately 400-600ms post stimulus onset. The FN400 tends to have mid-frontal scalp distribution which can extend to left and right frontal areas and central midline regions. In contrast, recollection has been linked with modulation of positive going waveform that emerges approximately 600ms post stimulus and is typically maximal over parietal sites and referred to as late positive component (LPC). In addition, FN400 is found to increase gradually as a function of item retrieval confidence whereas LPC is limited to high confidence retrieval response.

High Definition transcranial Direct Current Stimulation (HD-tDCS ) is a non-invasive neuromodulation technique. Compared to the standard bipolar montage used by the conventional tDCS, it uses arrays of smaller, specially designed electrodes to deliver a constant and low current directly to the cortical brain areas to increase the spatial focality. Studies show that the cortical area undergoing stimulation with HD-tDCS is more restricted compared to the standard bipolar montage of conventional tDCS. Moreover, tDCS has been proposed as a therapeutic procedure in various diseases and tDCS in healthy adults have demonstrated to improve cognitive and memory performance, but information regarding the effects of HD-tDCS targeting the PCC and its impact on memory retrieval is scarce. By targeting the PCC area by HD-tDCS, we want to introduce a safer, easier-to-use and more accurate non-invasive neuromodulation procedure. The dysfunctions of posterior cingulate cortex hav been linked to a range of psychiatric and neurological condition such as Alzheimer's disease, schizophrenia, autism, depression and attention deficit hyperactivity disorder, as well as aging. It shows increased activity when subject retrieve autobiographical memories suggests its internal orientated function. PET and ERP combined studies have shown greater blood flow medial temporal lobe with a brief late positive ERP component in PCC. Therefore, in this study we aim to understand whether HD-tDCS targeting the PCC can modulate the late positive ERP component.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Richardson, Texas, United States, 75080
        • University of Texas at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Native English Speaker
  • Currently not using any medication
  • Capable of understanding and signing an informed consent

Exclusion Criteria:

  • Severe disease
  • Mental illness
  • Cardiac history
  • History of severe head injuries
  • History of epileptic seizures
  • Any implanted devices such as pacemaker, neurostimulator
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: active anodal HD-tDCS
Active anodal HD-tDCS stimulation applied during memory task
Device: active anodal HD-tDCS
1) active anodal HD-tDCS with memory task
Sham Comparator: sham HD-tDCS
Sham HD-tDCS stimulation during memory task for comparison
Device: sham HD-tDCS
2) sham HD-tDCS with memory task
Experimental: active cathodal HD-tDCS
Active cathodal HD-tDCS stimulation applied during memory task
Device: active cathodal HD-tDCS
3) active cathodal HD-tDCS with memory task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recognition Memory Assessed by a Retrieval Memory Experiment
Time Frame: Retrieval Memory is assessed after 90 seconds break following the recognition phase.
Participants had to learn an association between a face and a name. The face-name association memory task was divided into (1) an encoding phase, (2) a consolidation phase, and (3) a retrieval phase. During the encoding phase, participants studied 60 successively presented face-name pairs. Participants were instructed to assess the gender of each face shown to keep participants focused on the task. The encoding phase lasted approximately 5 minutes. This is followed by a consolidation phase where participants were instructed to "sit still, relax, and think about nothing in particular" for 10 minutes. During the retrieval phase, participants were presented with 60 old and 60 new faces and were instructed to assess whether they had seen this face during the encoding phase, or if it was a 'new' face. Participants received active or sham transcranial direct current stimulation targetting the posterior cingulate cortex during retrieval. The outcome is correctly recalled old faces.
Retrieval Memory is assessed after 90 seconds break following the recognition phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-01 (National Center for Advancing Translational Sciences (NCATS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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