Effect of aiTBS on Intrinsic Spectral Dynamics and Task Performance

NCT07565207 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-6524
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim 1: Measure local shifts in cortical spectral dynamics following aiTBS. Aim 2: Measure network-specific shifts in task performance following aiTBS. Exploratory aim: Evaluate changes to resting state spectral dynamics in absence of stimulation after aiTBS.

Conditions

Brain Plasticity

Keywords

transcranial magnetic stimulation; electroencephalography

Outcome Measures

Primary Outcomes (2)

• Spectral Dynamics

  All participants will undergo TEP measurements before and after aiTBS therapy (peri-therapeutic) at the left DLPFC and left TPJ to evaluate changes cortical excitability. We will average the results of repeated single pulse stimulation at an intensity of 120% RMT. Participants will also undergo scalp EEG recording during aiTBS sessions and while at rest. Peri-therapeutic oscillatory bands will be determined by averaging responses to across multiple baseline recording sessions using the MATLAB toolbox FieldTrip for detection of signal within the 4-8Hz spectral band. We hypothesize that theta power increases in participants after completing three days of aiTBS when compared against their respective baselines. Intra-therapeutic changes to theta oscillatory signal will also be collected as an additional primary outcome. Averages of theta oscillatory power within each day of aiTBS will be recorded and compared against baseline.

  Participants will undergo six study visits spaced over a 2-week period. Outcome measures will be collected during study visits 2-6 during week 2.

• Task Performance

  Participants will complete both a working memory and affective interference task. The primary outcome measure will be task performance as measured by response time for each subject. Values collected after aiTBS will be compared against their pre-stimulation counterparts using a paired t-test for a given task. The change in these metrics will then be compared across the two tasks using an unpaired t-test. Change in performance metrics for each task will similarly be compared against changes in metrics of the participant group receiving stimulation to the alternate site. We hypothesize performance on network-congruent tasks increase after aiTBS.

  Participants will undergo six study visits spaced over a 2-week period. Outcome measures will be collected during study visits 2-6 during week 2.

Study Arms (2)

dlPFC TMS

EXPERIMENTAL

Individualized left dlPFC targets will be identified using task-based fMRI activation during the baseline Sternberg. BOLD activity maps from the retention interval will be masked with a left dlPFC region of interest defined from a group-level analysis of an independent Sternberg dataset. Activity will be contrasted between sort and maintain conditions, and the peak voxel within this mask will be extracted as the individualized target.

Device: TBS

TPJ TMS

EXPERIMENTAL

Individualized left TPJ targets will be identified using task-based fMRI activation during the baseline Sternberg. BOLD activity maps from the retention interval will be masked with a left TPJ region of interest defined from a group-level analysis of an independent Sternberg dataset. Activity will be contrasted between sort and maintain conditions, and the peak negative voxel within this mask will be extracted as the individualized target.

Device: TBS

Interventions

TBS DEVICE

aiTBS stimulation parameters. A MagVenture MagPro 100X stimulator with a B65 figure-8 coil will be used for the aiTBS sessions. A series of 20, 10 s trains will be presented over the course of the \~3.5 min session. Each train will consist of 2 s of stimulation with an 8 s ITI. During the 2 s of stimulation, 10, 50 Hz bursts will be repeated at intervals of 200 ms (5 Hz).

TPJ TMS; dlPFC TMS

Eligibility Criteria

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

You may qualify if:

• Able to give their consent
• Right-handed or ambidextrous

You may not qualify if:

• Non-english speaking
• Current or past non-anxiety-related psychiatric comorbidity.
• Active or history of active suicidal ideation
• Alcohol/drug problems in the past year or lifetime alcohol or drug dependence
• Medications that act on the central nervous system
• History of seizure
• History of epilepsy
• Increased risk of seizure for any reason
• Pregnancy, or positive pregnancy test
• Any medical (e.g., stroke, breathing problems, motion disorders) or neurological (e.g., a significant brain injury or brain infection history that increases seizure risk) condition that increases risk for fMRI or TMS (Protocol will follow recommendations from Rossi et al. 2021 doi:10.1016/j.clinph.2020.10.003)
• Any metal in their body which would make having an MRI scan unsafe
• Any sort of medical implants
• Hearing loss
• Claustrophobia
• orthostatic hypotension

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Officials

• Nicholas L Balderston, PhD

  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: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo six study visits spaced over a 2-week period (Figure 1). Visit 1 will occur during week one and Visits 2-6 will occur during week two. Spacing between Visit 1 and Visit 2 may be adjusted to accommodate the schedule of the participant, study team, or to accommodate available resources, with the restriction that there will always be a minimum of two days between Visit 1 and Visit 2. On Visit 1, subjects will undergo the following procedures: 1) informed consent, 2) baseline assessment, 3) motor threshold assessment, and 4) a pre-stimulation MRI visit where they will complete the Sternberg WM Task, resting state fMRI, and all the other structural imaging needed to identify the optimal target and orientation of stimulation. Information from the targeting scan will be used to perform neuronavigation to ensure accurate target stimulation. The targeting scan may be skipped if existing data can be used for targeting. On visits 2 and 6, participants will complete the

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