Arousal-related Memory Following Theta Burst Stimulation.
Arousal-related Memory of Movie Clips During Individualized IPS Targeting fMRI and TBS.
Aim 1: Active cTBS to IPS will disrupt arousal-dependent temporal memory, reflected in reduced relative order discrimination accuracy and expanded temporal distance estimates, relative to sham.
Aim 2: Active iTBS to IPS will enhance arousal-dependent temporal memory, reflected in improved relative order discrimination accuracy and compressed temporal distance estimates, relative to sham.
Aim 3: Baseline physiological arousal, trait anxiety (STAI), Beck Anxiety Inventory (BAI), trauma symptoms (PCL-5), and individualized E-field strength will predict the magnitude of TBS-induced behavioral changes in temporal memory.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Aim 1 (cTBS): Behavioral outcomes will include relative order discrimination and temporal distance estimation. Data will be analyzed using linear mixed-effects models with fixed effects of stimulation condition (cTBS vs. Sham-cTBS), session (Week 2 vs. Week 4) within the cTBS group, counterbalanced across active and sham sessions, and their interaction, and random intercepts and slopes for participants to account for repeated measures. Continuous physiological arousal (heart rate) and subjective arousal ratings during encoding will be included as covariates. Neural analyses will focus on baseline fMRI collected during high-arousal movie clips. Regions of interest (ROIs) include the intraparietal sulcus, amygdala subregions (basolateral and central-medial), anterior and posterior hippocampus, and perirhinal cortex. IPS-linked network connectivity at baseline will be modeled as a predictor of behavioral sensitivity to cTBS, rather than measuring post-TBS changes. Multiple comparisons will be controlled using false discovery rate (FDR) correction at q < .05.
Aim 2 (iTBS): Analyses will mirror Aim 1, substituting iTBS versus Sham-iTBS as the primary contrast. Behavioral indices of temporal memory and physiological arousal (heart rate, continuous ratings) during encoding will serve as primary outcomes. Baseline IPS connectivity measures will be used to examine individual susceptibility to iTBS modulation of behavior. ROI-level analyses will apply FDR correction (q < .05). Voxelwise exploratory analyses of baseline functional connectivity may be conducted, with AFNI 3dLME modeling and cluster correction via 3dClustSim (voxelwise p < 0.001, cluster α = 0.05).
Aim 3 - Individual Differences and Exploratory Contrasts: Individual difference analyses will incorporate baseline arousal indices, self-report measures (STAI, BAI, PCL-5), and participant-specific electric field (E-field) estimates from SimNIBS (individualized modeling software) as continuous moderators. Mixed-effects models will examine condition × moderator interactions to determine whether baseline physiology, self-report anxiety measures, or E-field strength predict differential behavioral sensitivity to cTBS or iTBS. Session order will be included as a covariate to account for potential practice or carryover effects. FDR correction (q < .05) will be applied across all behavioral and ROI-level analyses.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nicholas Balderston
- Numéro de téléphone: 12157463058
- E-mail: nicholas.balderston@pennmedicine.upenn.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Able to provide informed consent
- Right-handed (to ensure consistency in motor threshold determination)
Exclusion Criteria:
- Non-English speaking
- Significant medical problems
- Current or past psychiatric disorder
- Active or history of suicidal ideation
- Alcohol or drug problems in the past year, or lifetime alcohol or drug dependence
- Medications affecting the central nervous system
- History of seizure, epilepsy, or other neurological problems
- Any increased risk for seizure
- Pregnancy
- Medical conditions that increase risk for fMRI or TMS
- Metal in the body that makes MRI unsafe
- Medical implants
- Claustrophobia
- Orthostatic hypotension
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: cTBS
cTBS: Each session will consist of a single continuous 600-pulse train delivered over 40 seconds, comprising 50 Hz bursts repeated at 5 Hz.
|
Theta Burst Stimulation (TBS): TBS will be delivered using a MagVenture MagPro X100 stimulator with a Cool-B65 A/P coil.
One session of 600 pulses will be delivered per visit.
Theta Burst Stimulation (TBS): TBS will be delivered using a MagVenture MagPro X100 stimulator with a Cool-B65 A/P coil.
One session of 600 pulses will be delivered per visit.
|
|
Expérimental: iTBS
iTBS: Each session (~3.5 min) will consist of 20 trains of 10 seconds, comprising 2 seconds of 50 Hz bursts repeated at 5 Hz, with 8-second inter-train intervals, totaling 600 pulses per session.
|
Theta Burst Stimulation (TBS): TBS will be delivered using a MagVenture MagPro X100 stimulator with a Cool-B65 A/P coil.
One session of 600 pulses will be delivered per visit.
Theta Burst Stimulation (TBS): TBS will be delivered using a MagVenture MagPro X100 stimulator with a Cool-B65 A/P coil.
One session of 600 pulses will be delivered per visit.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Relative Order Discrimination
Délai: Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
|
Participants will view sequences of emotionally arousing movie clips and judge the chronological order in which specific events occurred.
Accuracy in determining sequential order will serve as a primary measure of temporal memory.
|
Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
|
|
Temporal Distance Estimation
Délai: Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
|
Following each clip sequence, participants will estimate the perceived temporal distance between events.
These estimates will capture subjective distortions in the encoding of elapsed time under arousal.
|
Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nicholas L Balderston, University of Pennsylvania
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-6446
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .