Decoding and Selective Modulation of Human Memory During Awake/Sleep Cycles

October 9, 2025 updated by: Itzhak Fried, University of California, Los Angeles
The proposed project seeks to elucidate memory processes and consolidation during sleep by leveraging the unique capability of direct recordings from the human brain at multiple levels of resolution-single neurons, localized neuronal assemblies, intracranial local field potentials-during rich behavioral tasks with real-life narratives and extracting neural features that relate to different aspects of episodic experience. The investigators will further probe causal mechanisms of consolidation by application of auditory and electrical stimulations during sleep and its effect on modulating memory processes.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
150

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All epilepsy patients between the ages of 18 and 65 who undergo depth electrode placement for clinical purposes
  • Eligibility is determined by the epilepsy surgery team (based on neuropsychological testing and on psychiatric evaluation)
  • Willing to provide informed consent and participate the study

Exclusion Criteria:

  • Neurological or psychiatric issues, other than epilepsy, that would put the patient at risk
  • Patient is younger than 18 or older than 65 years of age
  • Unwilling to provide informed consent

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

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 Accuracy
Time Frame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks
Accuracy will be analyzed to evaluate performance on memory tasks before and after sleep, specifically the ability to recognize correct items compared to all items. Accuracy will be measured using the sum of true positive and true negative divided by the total number of items. A within-subjects design will be employed and accuracy for stimulated vs. non-stimulated items will be compared.
1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks
Recognition Discriminability (D-prime)
Time Frame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks.
Discriminability will be analyzed to evaluate performance on memory tasks before and after sleep, specifically the ability to recognize target items from distractor items. Discriminability will be measured using a discriminability index (d-prime). In addition to d-prime being a normalized metric, it provides critical and complementary information to the accuracy metric (Outcome 1) given that it is a measure of sensitivity (and not bias) in the cases where data labels are not balanced . A within-subjects design will be employed and discriminability for stimulated vs. non-stimulated items will be compared.
1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Power sleep oscillations
Time Frame: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
The power of slow waves, spindles, ripples (all in units of dbm) will be computed. Employing a within-subjects design, the investigators will compare the change in the power of these oscillatory features for stimulated vs. non-stimulated items.
1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
Neuronal replay index
Time Frame: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
Neuronal replay index, defined as the percentage of time during which neurons manifest replay-like activation as compared to the duration of deep sleep will be computed. Employing a within-subjects design, the investigators will compare the replay measure for stimulated vs. non-stimulated items.
1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.

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.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)
University of Iowa

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.
July 13, 2022

Primary Completion (Estimated)

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.
August 31, 2026

Study Completion (Estimated)

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.
August 31, 2026

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).
June 18, 2022

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.
July 6, 2022

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.
July 11, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
October 14, 2025

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.
October 9, 2025

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.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • U01NS123128 (U.S. NIH Grant/Contract)
  • 1U01NS123128-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will make data available in accordance with the latest BRAIN Initiative Data Sharing Plan. The data consists of intracranial recordings from human epilepsy patients while participants perform a cognitive task during awake periods and follow-up recordings during overnight sleep or nap sessions. These datasets will be shared in a HIPAA-compliant manner (anonymized and coded) and will not include any sensitive information such as Protected Health Information. The investigators plan to deposit the data using the NIH Data Archive Brain Initiative platform, specialized at storage and organization of invasive neurophysiology data.

IPD Sharing Time Frame

All data will be provided by the time publication occurs or per NIH latest policies for the data to be shared periodically via specialized storage for invasive neurophysiology data.

IPD Sharing Access Criteria

Researchers can request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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