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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07580183
Spatial Scene Recognition Memory in Epilepsy Surgery
Investigations of Spatial Recognition Memory to Improve Cognitive Outcomes in Epilepsy Surgery
Panoramica dello studio
Stato
Condizioni
- Disturbi della memoria
- Epilessia focale
- Epilessia del lobo temporale
- Epilessia, lobo temporale
- Epilessia Intrattabile
- Deficit di memoria
- Percezione spaziale
- Disfunzione della memoria
- Chirurgia dell'epilessia
- Epilessia medicamente refrattaria
- Disturbo della memoria, spaziale
- Comorbidità dell'epilessia
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nigel P Pedersen, MD
- Numero di telefono: 916-734-3251
- Email: nppedersen@health.ucdavis.edu
Luoghi di studio
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California
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Sacramento, California, Stati Uniti, 95817
- Reclutamento
- UC Davis Medical Center
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Contatto:
- Nigel P Pedersen, MD
- Numero di telefono: 916-734-3251
- Email: nppedersen@health.ucdavis.edu
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Reclutamento
- Emory University Hospital
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Contatto:
- Daniel L Drane, PhD
- Numero di telefono: 404-727-2844
- Email: ddrane@emory.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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.
|
|
Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Scene familiarity discrimination accuracy
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Déjà vu report rate
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
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Date di iscrizione allo studio
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- neuropsicologia
- potenziali legati agli eventi
- coscienza
- ippocampo
- SEEG
- chirurgia dell'epilessia
- memoria spaziale
- familiarità
- EEG intracranico
- stereoelettroencefalografia
- 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
Termini MeSH pertinenti aggiuntivi
- Sindromi epilettiche
- Manifestazioni neurologiche
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Manifestazioni neurocomportamentali
- Epilessia
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Comportamento spaziale
- Epilessia resistente ai farmaci
- Disturbi della memoria
- Epilessie, parziali
- Epilessia, lobo temporale
- Orientamento, spaziale
Altri numeri di identificazione dello studio
- 2347891
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Disturbi della memoria
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Charite University, Berlin, GermanyReclutamentoSchizofrenia Spectrum Disorders (SSD)Germania
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University of Trás-os-Montes and Alto DouroCentro Hospitalar De Trás-Os-Montes E Alto Douro, E.P.E.ReclutamentoDisturbi psicotici | Grave malattia mentale | Schizofrenia Spectrum Disorders (SSD)Portogallo
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Central Institute of Mental Health, MannheimReclutamentoSchizofrenia Spectrum Disorders (SSD)Germania
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Tianjin Medical University General HospitalReclutamentoNeuromielite Optica Spectrum Disorders (NMOSD)Cina
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Huashan HospitalCompletato
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Tianjin Medical University General HospitalNon ancora reclutamentoNeuromielite ottica (NMO) | Neuromielite Optica Spectrum Disorders (NMOSD)
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Huashan HospitalNon ancora reclutamentoNeuromielite Optica Spectrum Disorders (NMOSD)Cina
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Huashan HospitalShanghai AbelZeta Ltd.Non ancora reclutamentoEncefalite autoimmune | Sclerosi multipla (SM) | Sindrome della persona rigida | Neuromielite Optica Spectrum Disorders (NMOSD)
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RenJi HospitalAbelZeta Pharma Inc.ReclutamentoMiastenia grave | Lupus eritematoso sistemico (LES) | Sclerosi multipla (SM) | Sclerosi sistemica (SSc) | Miopatia necrotizzante immunomediata (IMNM) | Neuromielite Optica Spectrum Disorders (NMOSD)Cina
Prove cliniche su Virtual Tour Recognition Memory Task
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Cukurova UniversityCompletatoAnsia | Procedure chirurgiche, elettive | Pazienti preoperatoriTacchino
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Berker OkayReclutamentoStress, Psicologico | Ansia | PauraTurchia (Türkiye)
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University of Colorado, DenverBinghamton UniversityAttivo, non reclutanteCommozione cerebraleStati Uniti