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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicholas Balderston
- Número de teléfono: 12157463058
- Correo electrónico: nicholas.balderston@pennmedicine.upenn.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
|
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Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Relative Order Discrimination
Periodo de tiempo: Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
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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.
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Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
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Temporal Distance Estimation
Periodo de tiempo: Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
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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.
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Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicholas L Balderston, University of Pennsylvania
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-6446
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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