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Afkodning og selektiv modulering af menneskelig hukommelse under vågen/søvncyklusser

31. oktober 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • California
      • Los Angeles, California, Forenede Stater, 90095
        • Rekruttering
        • University of California Los Angeles
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recognition Accuracy
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Power sleep oscillations
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juli 2022

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

18. juni 2022

Først indsendt, der opfyldte QC-kriterier

6. juli 2022

Først opslået (Faktiske)

11. juli 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • U01NS123128 (U.S. NIH-bevilling/kontrakt)
  • 1U01NS123128-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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