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- Ensaio Clínico NCT07565194
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Nicholas Balderston
- Número de telefone: 12157463058
- E-mail: nicholas.balderston@pennmedicine.upenn.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative Order Discrimination
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-6446
Plano para dados de participantes individuais (IPD)
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