- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07580183
Spatial Scene Recognition Memory in Epilepsy Surgery
Investigations of Spatial Recognition Memory to Improve Cognitive Outcomes in Epilepsy Surgery
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Nigel P Pedersen, MD
- Telefonnummer: 916-734-3251
- E-post: nppedersen@health.ucdavis.edu
Studieorter
-
-
California
-
Sacramento, California, Förenta staterna, 95817
- Rekrytering
- UC Davis Medical Center
-
Kontakt:
- Nigel P Pedersen, MD
- Telefonnummer: 916-734-3251
- E-post: nppedersen@health.ucdavis.edu
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory University Hospital
-
Kontakt:
- Daniel L Drane, PhD
- Telefonnummer: 404-727-2844
- E-post: ddrane@emory.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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
|
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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Scene familiarity discrimination accuracy
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Déjà vu report rate
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- neuropsykologi
- händelserelaterade potentialer
- medvetande
- hippocampus
- SEEG
- epilepsikirurgi
- rumsligt minne
- förtrogenhet
- intrakraniellt EEG
- stereo-elektroencefalografi
- 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
Ytterligare relevanta MeSH-villkor
- Epileptiska syndrom
- Neurologiska manifestationer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neurobehavioral manifestationer
- Epilepsi
- Patologiska tillstånd, tecken och symtom
- Beteende
- Tecken och symtom
- Rumsligt beteende
- Läkemedelsresistent epilepsi
- Minnesstörningar
- Epilepsi, partiell
- Epilepsi, temporallob
- Orientering, rumslig
Andra studie-ID-nummer
- 2347891
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .