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Spatial Scene Recognition Memory in Epilepsy Surgery

6. Mai 2026 aktualisiert von: Nigel P. Pedersen, BSc MBBS, University of California, Davis

Investigations of Spatial Recognition Memory to Improve Cognitive Outcomes in Epilepsy Surgery

This study investigates the anatomical and physiological basis of spatial scene recognition memory in patients with temporal lobe epilepsy and temporal lobe lesions. Standard neuropsychological tests are insensitive to important memory deficits experienced by patients, particularly in spatial/scene memory, recollective experience, and familiarity processing. Using a validated virtual tour paradigm, the study examines how familiarity-based recognition and recall of spatial scenes relate to specific brain structures. In Aim I, a large cohort of patients with varied temporal lobe lesions at Emory University undergoes the virtual tour task with voxel-based lesion-symptom mapping to localize necessary brain regions. In Aim II, scalp event-related potentials and eye tracking in healthy participants at UC Davis characterize the temporal dynamics and lateralization of scene recognition. In Aim III, intracranial EEG recordings (including local field potentials and single-unit activity) in epilepsy surgery patients at UC Davis determine the precise network dynamics underlying spatial scene familiarity and recall. The long-term goal is to improve the prediction and prevention of cognitive morbidity from epilepsy surgery by providing a more complete model of spatial recognition memory circuits.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Recognition memory can be divided into familiarity (a sense that something has been encountered before) and recollection (identification or elaborative recall). Patients with temporal lobe epilepsy often report subjective memory difficulties that are not captured by conventional neuropsychological tests, which lack assessments of true episodic and scene memory. This study uses a virtual tour paradigm that objectively separates familiarity-based recognition from recall for spatial scenes. The central hypothesis is that spatial scene recognition memory critically involves the convergence of dorsal and ventral visual streams in the inferior parietal lobule and parahippocampal gyrus, with familiarity-based recognition involving neocortical structures and recall involving the parahippocampal gyrus, entorhinal cortices, and hippocampus. The study employs three complementary approaches: (1) lesion-symptom mapping in ~310 surgical patients and 150 controls, (2) scalp ERP and eye-tracking in 80 healthy participants, and (3) intracranial electrophysiology (LFP and single-unit recordings) in ~80 patients undergoing stereoelectroencephalography (SEEG) for clinical seizure localization. Research electrodes (FDA-approved Dixi micro-macro or Behnke-Fried with tetrode components) are placed at clinically determined locations to additionally capture single-neuron activity. This study was classified as a Basic Experimental Studies in Humans (BESH) mechanism; it does not evaluate a health-related clinical outcome but uses clinical populations and FDA-approved research electrodes to study basic neuroscience questions about memory.

Studientyp

Interventionell

Einschreibung (Geschätzt)

620

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • Sacramento, California, Vereinigte Staaten, 95817
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Rekrutierung
        • Emory University Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Age 18 years or older
  • For Aims I and III: Diagnosis of focal epilepsy or temporal lobe lesion; patients undergoing evaluation for or having undergone epilepsy surgery
  • For Aim II: Healthy adult participants
  • Full-Scale IQ ≥ 70
  • English proficiency sufficient to understand and complete the task
  • For Aim I: Enrolled in or eligible for Emory University epilepsy surgery research registry
  • For Aim III: Undergoing clinically indicated stereoelectroencephalography (SEEG) at UC Davis Medical Center
  • Able to provide informed consent (or for Aim I retrospective component, prior consent in Emory registry)

Exclusion Criteria:

  • Full-Scale IQ < 70
  • Inability to provide informed consent
  • For Aim III: Age > 55 years
  • For Aim II: History of neurological or psychiatric disorder (as applicable per study protocol)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Aim I: Lesion-Symptom Mapping

Patients with temporal lobe lesions (n≈310) and healthy controls (n≈150) at Emory University. Retrospective cohort with existing surgical lesions plus prospectively enrolled new surgical patients (~60 over 5 years).

Intervention(s): Behavioral: Virtual Tour Recognition Memory Task; Diagnostic: MRI neuroimaging and neuropsychological assessment
Verhalten: Virtual Tour Recognition Memory Task
Participants are passively navigated through virtual tour scenes (5-second video clips) during a study phase and are asked to generate descriptive names for each scene. During the test phase, they view novel, spatially similar (same configuration, different objects), or identical scenes and rate familiarity, indicate old/new judgments, report déjà vu sensations, and attempt to recall scene names. The task consists of two study-test blocks. This is a cognitive/behavioral assessment, not a therapeutic intervention.
Diagnosetest: MRI Neuroimaging and Neuropsychological Assessment (Aim I)
Pre- and post-surgical structural MRI (T1-weighted, diffusion-weighted imaging, resting-state fMRI) obtained as part of the clinical epilepsy surgery evaluation at Emory University. Extensive neuropsychological battery administered pre- and post-operatively (6 months and 1 year) including Wechsler memory scales, Rey-Osterrieth Complex Figure, confrontation naming, and additional measures.
Experimental: Aim II: Scalp ERP Study
Healthy participants (n=80) recruited from UC Davis campus community. Intervention: Behavioral: Virtual Tour Recognition Memory Task (still-image version) during Scalp EEG/ERP recording and eye tracking
Verhalten: Virtual Tour Recognition Memory Task
Participants are passively navigated through virtual tour scenes (5-second video clips) during a study phase and are asked to generate descriptive names for each scene. During the test phase, they view novel, spatially similar (same configuration, different objects), or identical scenes and rate familiarity, indicate old/new judgments, report déjà vu sensations, and attempt to recall scene names. The task consists of two study-test blocks. This is a cognitive/behavioral assessment, not a therapeutic intervention.
Experimental: Aim III: Intracranial EEG

Patients with epilepsy undergoing clinically indicated SEEG (n≈80) at UC Davis Medical Center.

Behavioral Intervention: Virtual Tour Recognition Memory Task; Other Intervention: Intracranial EEG recording via clinically placed electrodes, a minority of which have research microelectrodes (FDA-approved Dixi micro-macro or Behnke-Fried Ad-Tech electrodes)
Verhalten: Virtual Tour Recognition Memory Task
Participants are passively navigated through virtual tour scenes (5-second video clips) during a study phase and are asked to generate descriptive names for each scene. During the test phase, they view novel, spatially similar (same configuration, different objects), or identical scenes and rate familiarity, indicate old/new judgments, report déjà vu sensations, and attempt to recall scene names. The task consists of two study-test blocks. This is a cognitive/behavioral assessment, not a therapeutic intervention.
Gerät: Intracranial EEG Recording with Research Electrodes (Aim III only)
Patients undergoing clinically indicated stereoelectroencephalography (SEEG) for seizure localization have electrodes implanted at locations determined solely by clinical need. In a subset of patients, FDA-approved research electrodes (Dixi micro-macro electrodes or Behnke-Fried As-Tech electrodes with tetrode components) substitute standard clinical electrodes at the same clinically determined locations. These electrodes have the same geometry as clinical electrodes and are FDA-approved. The tetrode component enables single-neuron recording for research purposes and adds no additional risk. Electrode placement is not altered by study participation. Local field potentials (LFP) and, where available, single-unit data are recorded during the virtual tour task and resting state.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Scene familiarity discrimination accuracy
Zeitfenster: From enrollment until the end of eight weeks, during which time testing is scheduled (Aim II), or during the hospitalization for invasive EEG studies (Aim III). Participants in Aim I can undergo repeat testing (six months, one year, etc.)
Rate of correct familiarity judgments for spatially similar test scenes versus novel scenes (recognition without identification/RWI effect), measured as the proportion of "familiar" responses to configurally matched scenes minus false alarm rate to novel scenes.
From enrollment until the end of eight weeks, during which time testing is scheduled (Aim II), or during the hospitalization for invasive EEG studies (Aim III). Participants in Aim I can undergo repeat testing (six months, one year, etc.)
Scene recall accuracy
Zeitfenster: From enrollment until the end of eight weeks, during which time testing is scheduled (Aim II), or during the hospitalization for invasive EEG studies (Aim III). Participants in Aim I can undergo repeat testing (six months, one year, etc.)
Proportion of test scenes for which participants correctly recall the name or identifying details of the corresponding study scene (verified recall), separately for identical repeat scenes and configurally similar scenes.
From enrollment until the end of eight weeks, during which time testing is scheduled (Aim II), or during the hospitalization for invasive EEG studies (Aim III). Participants in Aim I can undergo repeat testing (six months, one year, etc.)
Lesion-symptom correlation for familiarity and recall (Aim I)
Zeitfenster: Testing is scheduled within eight weeks of enrollment for all patients, with repeat testing at six and 12 months after surgery for those enrolled pre-operatively
Voxel-based lesion-symptom mapping (VBLSM) correlating surgical lesion volumes in temporal lobe subregions (temporopolar, perirhinal, entorhinal, parahippocampal, hippocampal) with familiarity and recall behavioral scores.
Testing is scheduled within eight weeks of enrollment for all patients, with repeat testing at six and 12 months after surgery for those enrolled pre-operatively
ERP amplitude and latency associated with familiarity and recall (Aim II)
Zeitfenster: During EEG recording session
Amplitude and latency of event-related potential components (FN400, late positive component) in specified scalp regions (e.g., LAS, RAS, LPS, RPS) as a function of scene familiarity and recall conditions.
During EEG recording session
Intracranial theta and gamma power and connectivity during familiarity judgments (Aim III)
Zeitfenster: During intracranial EEG monitoring (typically 1-2 weeks hospital stay)
Theta (3-7 Hz) and gamma-band (30-150 Hz) event-related synchronization/desynchronization in parahippocampal, perirhinal, entorhinal, and hippocampal contacts during familiarity versus recall conditions, plus functional connectivity measures (imaginary coherence, phase-amplitude coupling).
During intracranial EEG monitoring (typically 1-2 weeks hospital stay)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Déjà vu report rate
Zeitfenster: During testing sessions with the virtual tour
Proportion of test trials in which participants report a feeling of déjà vu, analyzed by scene condition (similar, repeat, novel).
During testing sessions with the virtual tour
Vividness of Visual Imagery Questionnaire, Second Edition (VVIQ-2) scores (Aim I)
Zeitfenster: During testing session
Self-reported vividness of visual imagery correlated with lesion location and recognition memory performance. The VVIQ-2 is a 32-item self-report questionnaire in which each item is rated on a scale from 1 (no image at all) to 5 (perfectly clear and vivid). Total scores range from 32 to 160. Higher scores indicate more vivid visual imagery.
During testing session
Hyperfamiliarity commission errors
Zeitfenster: During testing session
Rate of false positive familiarity judgments for novel scenes (false alarms), as a measure of hyperfamiliarity.
During testing session
Neuropsychological test performance (Aim I)
Zeitfenster: Pre-surgery and 6 months / 1 year post-surgery
Standard neuropsychological battery scores (Wechsler Memory Scale, Rey-Osterrieth Complex Figure, confrontation naming, etc.) correlated with virtual tour performance and lesion characteristics.
Pre-surgery and 6 months / 1 year post-surgery
Single-unit firing rate (subset of patients in Aim III)
Zeitfenster: During intracranial EEG monitoring
Mean firing rate (spikes per second) of individual neurons recorded from parahippocampal and perirhinal cortex during familiarity versus recall conditions, in patients with tetrode/microelectrode recordings.
During intracranial EEG monitoring
Single-unit stimulus selectivity (subset of patients in Aim III)
Zeitfenster: During intracranial EEG monitoring
Selectivity index (area under the receiver operating characteristic curve) quantifying the discriminability of familiar versus novel scene conditions in individual neurons recorded from parahippocampal and perirhinal cortex, in patients with tetrode/microelectrode recordings.
During intracranial EEG monitoring

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, Davis

Mitarbeiter

Emory University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2024

Primärer Abschluss (Geschätzt)

30. Juni 2030

Studienabschluss (Geschätzt)

30. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2026

Zuerst gepostet (Tatsächlich)

12. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2347891

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified behavioral data, EEG/ERP data, and intracranial electrophysiology data will be shared via OpenNeuro and Emory Dataverse upon reasonable request. Identifiable data will remain at collection sites.

IPD-Sharing-Zeitrahmen

Data will be made available by the end of the performance period or upon publication.

IPD-Sharing-Zugriffskriterien

De-identified data will be freely available. Requests prior to publication will be by discussion with the PI. A data use agreement may be required for certain datasets.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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