NCT07580183

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jul 2024Jun 2030

Study Start

First participant enrolled

July 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

6 years

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

spatial memoryrecognition memoryfamiliarityrecollectionneural circuits of memoryphenomenology of memoryscene memoryvirtual tourepilepsy surgerySEEGstereo-electroencephalographylesion-symptom mappingnetwork-symptom mappingcognitive electrophysiologyevent-related potentialsintracranial EEGiEEGparahippocampal gyrusperirhinal cortexhippocampustetrodesdeja vuneuropsychologyconsciousness

Outcome Measures

Primary Outcomes (5)

  • Scene familiarity discrimination accuracy

    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

    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)

    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)

    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)

    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)

Secondary Outcomes (6)

  • Déjà vu report rate

    During testing sessions with the virtual tour

  • Vividness of Visual Imagery Questionnaire, Second Edition (VVIQ-2) scores (Aim I)

    During testing session

  • Hyperfamiliarity commission errors

    During testing session

  • Neuropsychological test performance (Aim I)

    Pre-surgery and 6 months / 1 year post-surgery

  • Single-unit firing rate (subset of patients in Aim III)

    During intracranial EEG monitoring

  • +1 more secondary outcomes

Study Arms (3)

Aim I: Lesion-Symptom Mapping

EXPERIMENTAL

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

Behavioral: Virtual Tour Recognition Memory TaskDiagnostic Test: MRI Neuroimaging and Neuropsychological Assessment (Aim I)

Aim II: Scalp ERP Study

EXPERIMENTAL

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

Behavioral: Virtual Tour Recognition Memory Task

Aim III: Intracranial EEG

EXPERIMENTAL

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)

Behavioral: Virtual Tour Recognition Memory TaskDevice: Intracranial EEG Recording with Research Electrodes (Aim III only)

Interventions

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.

Aim I: Lesion-Symptom MappingAim II: Scalp ERP StudyAim III: Intracranial EEG

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.

Aim I: Lesion-Symptom Mapping

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.

Aim III: Intracranial EEG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Epilepsies, PartialEpilepsy, Temporal LobeMemory DisordersDrug Resistant EpilepsyOrientation, Spatial

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic SyndromesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Note: Under the NIH clinical trial definition used at the time of submission (2024-2025), this study is classified as a clinical trial because participants are prospectively assigned to interventions (cognitive testing paradigms; in Aim III, research electrode recordings). However, the primary purpose is basic science - understanding the neural basis of memory - not evaluating a clinical/health outcome.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Vice Chair of Research, Department of Neurology

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 12, 2026

Study Start

July 1, 2024

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available by the end of the performance period or upon publication.
Access Criteria
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.

Locations