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Focal EpilepsyNCT07580183

Spatial Scene Recognition Memory in Epilepsy Surgery

A study testing Virtual Tour Recognition Memory Task, Intracranial EEG Recording with Research Electrodes (Aim III only) and MRI Neuroimaging and Neuropsychological Assessment (Aim I) in people with Focal Epilepsy and Temporal Lobe Epilepsy, run by University of California, Davis at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Virtual Tour Recognition Memory Task, Intracranial EEG Recording with Research Electrodes (Aim III only) and MRI Neuroimaging and Neuropsychological Assessment (Aim I)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
620 participants
Where
2 sitesUnited States
Study dates
1 Jul 2024to 30 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nigel P Pedersen, MD contact

916-734-3251

nppedersen@health.ucdavis.edu

United States2 sites, 2 recruiting
  • Emory University Hospital

    Atlanta, Georgia, 30322

    Daniel L Drane, PhD, 404-727-2844, ddrane@emory.edu

    Recruiting
  • UC Davis Medical Center

    Sacramento, California, 95817

    Nigel P Pedersen, MD, 916-734-3251, nppedersen@health.ucdavis.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Virtual Tour Recognition Memory Task, Intracranial EEG Recording with Research Electrodes (Aim III only), MRI Neuroimaging and Neuropsychological Assessment (Aim I)
Keywords
spatial memory, recognition memory, familiarity, recollection, neural circuits of memory, phenomenology of memory, scene memory, virtual tour, epilepsy surgery, SEEG, stereo-electroencephalography, lesion-symptom mapping, network-symptom mapping, cognitive electrophysiology, event-related potentials, intracranial EEG, iEEG, parahippocampal gyrus, perirhinal cortex, hippocampus
Medical subject headings
Epilepsies, Partial, Epilepsy, Temporal Lobe, Memory Disorders, Drug Resistant Epilepsy, Orientation, Spatial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Tour Recognition Memory TaskBehavioural

    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.

  • Intracranial EEG Recording with Research Electrodes (Aim III only)Device

    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.

  • MRI Neuroimaging and Neuropsychological Assessment (Aim I)Diagnostic test

    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.

Study groups in NCT07580183
Study groupRoleWhat they receive
Aim I: Lesion-Symptom MappingExperimentalPatients 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
Receives: Behavioral: Virtual Tour Recognition Memory Task; Diagnostic Test: MRI Neuroimaging and Neuropsychological Assessment (Aim I)
Aim II: Scalp ERP StudyExperimentalHealthy 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
Receives: Behavioral: Virtual Tour Recognition Memory Task
Aim III: Intracranial EEGExperimentalPatients 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)
Receives: Behavioral: Virtual Tour Recognition Memory Task; Device: Intracranial EEG Recording with Research Electrodes (Aim III only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.)

  2. 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.

    Measured: 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.)

  3. 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.

    Measured: 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

  4. 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.

    Measured: During EEG recording session

  5. 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).

    Measured: During intracranial EEG monitoring (typically 1-2 weeks hospital stay)

Secondary outcomes (6)
  1. Déjà vu report rate

    Proportion of test trials in which participants report a feeling of déjà vu, analyzed by scene condition (similar, repeat, novel).

    Measured: During testing sessions with the virtual tour

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

    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.

    Measured: During testing session

  3. Hyperfamiliarity commission errors

    Rate of false positive familiarity judgments for novel scenes (false alarms), as a measure of hyperfamiliarity.

    Measured: During testing session

  4. Neuropsychological test performance (Aim I)

    Standard neuropsychological battery scores (Wechsler Memory Scale, Rey-Osterrieth Complex Figure, confrontation naming, etc.) correlated with virtual tour performance and lesion characteristics.

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

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

    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.

    Measured: During intracranial EEG monitoring

  6. Single-unit stimulus selectivity (subset of patients in Aim III)

    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.

    Measured: During intracranial EEG monitoring

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 Jul 2024
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07580183
Sponsor's protocol ID
2347891
Status last verified
May 2026
First submitted
30 Apr 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Tour Recognition Memory Task, Intracranial EEG Recording with Research Electrodes (Aim III only) and MRI Neuroimaging and Neuropsychological Assessment (Aim I) in people with Focal Epilepsy and Temporal Lobe Epilepsy, run by University of California, Davis at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nigel P Pedersen, MD (916-734-3251, nppedersen@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scene familiarity discrimination accuracy (time frame: 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.)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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