- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05452122
Afkodning og selektiv modulering af menneskelig hukommelse under vågen/søvncyklusser
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
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Andreina Hampton
- Telefonnummer: 3236105293
- E-mail: amhampton@mednet.ucla.edu
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- University of California Los Angeles
-
Kontakt:
- Andreina Hampton
- Telefonnummer: 3236105293
- E-mail: amhampton@mednet.ucla.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
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)?
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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