NCT05452122

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jul 2022Aug 2026

First Submitted

Initial submission to the registry

June 18, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

June 18, 2022

Last Update Submit

October 9, 2025

Conditions

Keywords

sleepstimulationmemorylearningsingle-unit

Outcome Measures

Primary Outcomes (2)

  • Recognition Accuracy

    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)

    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 Outcomes (2)

  • Power sleep oscillations

    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

    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.

Interventions

Electrical and auditory stimulation will be applied during sleep.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2022

First Posted

July 11, 2022

Study Start

July 13, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
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.
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.
More information

Locations