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Arousal-related Memory Following Theta Burst Stimulation.

27. april 2026 opdateret af: University of Pennsylvania

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Active TMS
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.
Enhed: Sham TMS
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.
Eksperimentel: 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.
Enhed: Active TMS
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.
Enhed: Sham TMS
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative Order Discrimination
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Efterforskere

  • Ledende efterforsker: Nicholas L Balderston, University of Pennsylvania

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. maj 2030

Studieafslutning (Anslået)

30. maj 2030

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-6446

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

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