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- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Christos Constantinidis, PhD
- Numéro de téléphone: +1 (615) 936-2020
- E-mail: christos.constantinidis.1@Vanderbilt.Edu
Sauvegarde des contacts de l'étude
- Nom: Lucas Chang, BS
- Numéro de téléphone: 615-421-3046
- E-mail: lucas.m.chang@vumc.org
Lieux d'étude
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt University Medical Center
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Contact:
- Christos Constantinidis, PhD
- Numéro de téléphone: (615) 936 - 2020
- E-mail: christos.constantinidis.1@Vanderbilt.Edu
-
Contact:
- Lucas Chang, BA
- Numéro de téléphone: 615-421-3046
- E-mail: lucas.m.chang@vumc.org
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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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Participants complete computerized neurocognitive tasks assessing working memory, response inhibition, decision-making, reward processing, and other related cognitive functions during sEEG monitoring.
Tasks may include the stop signal reaction time task, the n-back working memory task, the delayed response task, the match/nonmatch task, the gambling task, the card guessing task, and the emotional stop signal reaction time task.
Intracranial neural activity is recorded during task performance, and select tasks may include research electrical stimulation delivered through the implanted sEEG electrodes.
Neurophysiology system designed to allow recording of neural signals as well as delivery of neural stimulation.
The system is a portable unit which is connected to cables connected to the clinical electrodes.
Neurophysiology signals from the electrodes can be recorded, amplified, and processed by the unit.
The unit also has the ability to deliver electrical stimulation through the electrodes according to programmed parameters.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Local field potential changes in response to working memory tasks
Délai: 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
Délai: 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 stimulation
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 251231 (Vanderbilt University Medical Center IRB)
- 1R21MH139624-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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