- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07580183
Spatial Scene Recognition Memory in Epilepsy Surgery
Investigations of Spatial Recognition Memory to Improve Cognitive Outcomes in Epilepsy Surgery
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Nigel P Pedersen, MD
- Telefonszám: 916-734-3251
- E-mail: nppedersen@health.ucdavis.edu
Tanulmányi helyek
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California
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Sacramento, California, Egyesült Államok, 95817
- Toborzás
- UC Davis Medical Center
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Kapcsolatba lépni:
- Nigel P Pedersen, MD
- Telefonszám: 916-734-3251
- E-mail: nppedersen@health.ucdavis.edu
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30322
- Toborzás
- Emory University Hospital
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Kapcsolatba lépni:
- Daniel L Drane, PhD
- Telefonszám: 404-727-2844
- E-mail: ddrane@emory.edu
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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 |
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.
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.
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Kísérleti: 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
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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.
|
|
Kísérleti: 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) |
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.
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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Scene familiarity discrimination accuracy
Időkeret: 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.)
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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.
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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.)
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Scene recall accuracy
Időkeret: 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.)
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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.
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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.)
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Lesion-symptom correlation for familiarity and recall (Aim I)
Időkeret: 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
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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.
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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
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ERP amplitude and latency associated with familiarity and recall (Aim II)
Időkeret: During EEG recording session
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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.
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During EEG recording session
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Intracranial theta and gamma power and connectivity during familiarity judgments (Aim III)
Időkeret: During intracranial EEG monitoring (typically 1-2 weeks hospital stay)
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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).
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During intracranial EEG monitoring (typically 1-2 weeks hospital stay)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Déjà vu report rate
Időkeret: During testing sessions with the virtual tour
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Proportion of test trials in which participants report a feeling of déjà vu, analyzed by scene condition (similar, repeat, novel).
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During testing sessions with the virtual tour
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Vividness of Visual Imagery Questionnaire, Second Edition (VVIQ-2) scores (Aim I)
Időkeret: During testing session
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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.
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During testing session
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Hyperfamiliarity commission errors
Időkeret: During testing session
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Rate of false positive familiarity judgments for novel scenes (false alarms), as a measure of hyperfamiliarity.
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During testing session
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Neuropsychological test performance (Aim I)
Időkeret: Pre-surgery and 6 months / 1 year post-surgery
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Standard neuropsychological battery scores (Wechsler Memory Scale, Rey-Osterrieth Complex Figure, confrontation naming, etc.) correlated with virtual tour performance and lesion characteristics.
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Pre-surgery and 6 months / 1 year post-surgery
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Single-unit firing rate (subset of patients in Aim III)
Időkeret: During intracranial EEG monitoring
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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.
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During intracranial EEG monitoring
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Single-unit stimulus selectivity (subset of patients in Aim III)
Időkeret: During intracranial EEG monitoring
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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.
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During intracranial EEG monitoring
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Együttműködők és nyomozók
Szponzor
Együttműködők
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
- neuropszichológia
- eseményekhez kapcsolódó potenciálok
- öntudat
- hippokampusz
- SEEG
- epilepszia műtét
- térbeli memória
- ismertség
- intracranialis EEG
- sztereo-elektroencefalográfia
- recognition memory
- recollection
- neural circuits of memory
- phenomenology of memory
- scene memory
- virtual tour
- lesion-symptom mapping
- network-symptom mapping
- cognitive electrophysiology
- iEEG
- parahippocampal gyrus
- perirhinal cortex
- tetrodes
- deja vu
További vonatkozó MeSH feltételek
- Epilepsziás szindrómák
- Neurológiai megnyilvánulások
- Agyi betegségek
- Központi idegrendszeri betegségek
- Idegrendszeri betegségek
- Neuroviselkedési megnyilvánulások
- Epilepszia
- Kóros állapotok, jelek és tünetek
- Viselkedés
- Jelek és tünetek
- Térbeli viselkedés
- Gyógyszerrezisztens epilepszia
- Memóriazavarok
- Részleges epilepszia
- Epilepszia, temporális lebeny
- Tájolás, Térbeli
Egyéb vizsgálati azonosító számok
- 2347891
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
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