AnxietyNCT07565194
Arousal-related Memory Following Theta Burst Stimulation.
A study testing Active TMS in people with Anxiety, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Active TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide informed consent
- Right-handed (to ensure consistency in motor threshold determination)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Anxiety
- Being tested
- Active TMS, Sham TMS
- Keywords
- anxiety, transcranial magnetic stimulation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TMSDevice
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.
Sham TMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Active TMS; Device: Sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas L Balderston, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565194
- Sponsor's protocol ID
- 26-6446
- Status last verified
- Aug 2026
- First submitted
- 27 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arousal-related Memory of Movie Clips During Individualized IPS Targeting fMRI and TBS.
- ClinicalTrials.gov ID
- NCT07565194
- Acronym / sponsor ID
- 26-6446
- Conditions
- Anxiety
- Keywords
- anxiety, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| cTBS | Experimental | Device: Active TMS, Device: Sham TMScTBS: Each session will consist of a single continuous 600-pulse train delivered over 40 seconds, comprising 50 Hz bursts repeated at 5 Hz. |
| iTBS | Experimental | Device: Active TMS, Device: Sham TMSiTBS: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Able to provide informed consent
- Right-handed (to ensure consistency in motor threshold determination)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TMSTheta 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. | Device | cTBS, iTBS |
| Sham TMSTheta 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. | Device | cTBS, iTBS |
Primary outcome
Relative Order Discrimination
Time frame: 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.
Temporal Distance Estimation
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas L Balderston principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Active TMS in people with Anxiety, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Balderston (12157463058, nicholas.balderston@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Order Discrimination (time frame: Task will be administered immediately following TBS or sham stimulation at Weeks 2 and 4.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.