Arousal-related Memory Following Theta Burst Stimulation.

NCT07565194 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-6446
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety

Keywords

anxiety; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Relative Order Discrimination

  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

  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.

Study Arms (2)

cTBS

EXPERIMENTAL

cTBS: Each session will consist of a single continuous 600-pulse train delivered over 40 seconds, comprising 50 Hz bursts repeated at 5 Hz.

Device: Active TMS; Device: Sham TMS

iTBS

EXPERIMENTAL

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.

Device: Active TMS; Device: Sham TMS

Interventions

Active TMS DEVICE

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.

cTBS; iTBS

Sham TMS DEVICE

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.

cTBS; iTBS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide informed consent
• Right-handed (to ensure consistency in motor threshold determination)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nicholas L Balderston

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Balderston

CONTACT

12157463058; nicholas.balderston@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active and sham TMS will be delivered in a double-blind manner.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a mixed design: between-subjects for stimulation type (cTBS group vs. iTBS group) and within-subjects for stimulation condition (active vs. sham), counterbalanced across visits. Healthy adult volunteers will be assigned to either cTBS or iTBS. Each participant completes one active and one sham TBS session, separated by a washout period. Week 1 - Baseline MRI/Behavior: Structural and functional MRI to identify individualized IPS targets during arousal-inducing movie clips. Week 2 - Condition A (Active or Sham TBS): TBS delivered immediately prior to encoding six pseudo-randomized emotionally arousing movie clips. Behavioral testing follows encoding (relative order discrimination and temporal distance estimation). Active or sham assignment is counterbalanced within each group. Week 3 - Washout: No visits or stimulation. Ensures independence between Condition A and Condition B. Week 4 - Condition B (Opposite TBS Condition).

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04