- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07617506
Neural Basis of Human Working Memory
This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231.
This study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and/or single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Christos Constantinidis, PhD
- Telefonnummer: +1 (615) 936-2020
- E-mail: christos.constantinidis.1@Vanderbilt.Edu
Undersøgelse Kontakt Backup
- Navn: Lucas Chang, BS
- Telefonnummer: 615-421-3046
- E-mail: lucas.m.chang@vumc.org
Studiesteder
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Kontakt:
- Christos Constantinidis, PhD
- Telefonnummer: (615) 936 - 2020
- E-mail: christos.constantinidis.1@Vanderbilt.Edu
-
Kontakt:
- Lucas Chang, BA
- Telefonnummer: 615-421-3046
- E-mail: lucas.m.chang@vumc.org
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Undergoing SEEG monitoring at Vanderbilt University Medical Center
- Age >18
- English speaking
Exclusion Criteria:
- Age <18
- Not able to complete questionnaires (unable to comprehend instructions or follow directions)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Epilepsy patients
All participants will be patients with medically refractory epilepsy who have undergone depth electrode placement for stereo EEG monitoring for seizure localization.
Participants will complete working memory tasks and EEG recordings will be concurrently collected from their depth electrodes.
Some subjects will undergo macro-micro electrode implantation as a part of their SEEG implantation procedure for the purpose of EEG macro (local activity) and micro (single-unit) recordings.
Some subjects will complete working memory tasks with stimulation applied during task completion.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Local field potential changes in response to working memory tasks
Tidsramme: During patient's epilepsy monitoring stay, approximately 20-30 minutes
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Local field potential changes are from intracranial neural recordings taken while patients complete spatial working memory tasks.
In the manual remember 1 remember 2 task, patients are instructed to hold down a cursor on a central location box colored one color or another on screen, while two boxes in locations sequentially flash on screen.
Depending on the central location box color, the patient will drag their cursor to the first or second location box shown, after the central box has disappeared from screen.
In the retro remember 1 remember 2 task, the color of the central box color is not shown until both location boxes have flashed onscreen.
In the manual version, the central location box color is constant throughout the trial.
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During patient's epilepsy monitoring stay, approximately 20-30 minutes
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Single unit neuronal spiking changes in response to memory tasks
Tidsramme: During patient's epilepsy monitoring stay, approximately 20-30 minutes
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Single neuron spiking activity is recorded through SEEG micro neural recordings while patients complete working memory tasks.
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During patient's epilepsy monitoring stay, approximately 20-30 minutes
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Behavioral performance changes with simulation
Tidsramme: During patient's epilepsy monitoring stay, approximately 20-30 minutes
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Bipolar stimulation through pre-selected SEEG electrodes in the prefrontal cortex and surrounding areas will occur during the remember 1 remember 2 working memory tasks.
Stimulation will be performed via the Ripple Neuromed Summit system.
Stimulation will be tested with each patient prior to task to determine safety and tolerability, while patient is monitored by a neurosurgeon or neurologist.
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During patient's epilepsy monitoring stay, approximately 20-30 minutes
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
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
- 251231 (Vanderbilt University Medical Center IRB)
- 1R21MH139624-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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