Brain PlasticityNCT07565207
Effect of aiTBS on Intrinsic Spectral Dynamics and Task Performance
A study testing TBS in people with Brain Plasticity, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Plasticity
- What is being tested?
- TBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 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 give their consent
- Right-handed or ambidextrous
Who cannot join
- 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
Show all 15Show fewer
- 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
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: The Effect of Within-network aiTBS on Cortical Excitability, Intrinsic Oscillatory Bands, and Behavioral Task Performance
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.
Read the detailed description
Study Design. The study design comprises a two-group (DLPFC, TPJ) two-condition (active, sham) parallel design. Order of condition will be counterbalanced across subjects.
Aim 1 Outcome: 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.
Aim 2 Outcome: 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.
Data Analyses. The primary responses will be continuously distributed, and we will compare the active to sham conditions using linear mixed effects models. For the response of Aim 1, we will possibly transform the responses to reduce levels of skewness. When conducting TEP measurements, the order in which participants receive stimulation will be randomly assigned such that 50% of participants receive stimulation to the DLPFC first and 50% receive stimulation to the TPJ first. For the behavioral responses of Aim 2 we will use Fisher's z-transform to symmetrize the distribution and stabilize the variance. The models will include two-level categorical factors for treatment and period; as the period and treatment factors are categorical, these models accommodate arbitrary treatment effects, and, for example, do not assume a linear trend across the treatments. We will include random intercepts for participant and will check whether additional covariance structure is required to account for within-participant correlations. We will also examine treatment by period interaction effects. If these effects are significant, we will report estimated effects and associated standard errors and p-values separately by period; if the interaction effects are non-significant, then we will report estimates of effect pooled over periods.
- Conditions
- Brain Plasticity
- Being tested
- TBS
- Keywords
- transcranial magnetic stimulation, electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: TBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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 Brain PlasticityStudies 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
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas L Balderston, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565207
- Sponsor's protocol ID
- 26-6524
- 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
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
- The Effect of Within-network aiTBS on Cortical Excitability, Intrinsic Oscillatory Bands, and Behavioral Task Performance
- ClinicalTrials.gov ID
- NCT07565207
- Acronym / sponsor ID
- 26-6524
- Conditions
- Brain Plasticity
- Keywords
- transcranial magnetic stimulation, electroencephalography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 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: 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.
Detailed description
Study Design. The study design comprises a two-group (DLPFC, TPJ) two-condition (active, sham) parallel design. Order of condition will be counterbalanced across subjects.
Aim 1 Outcome: 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.
Aim 2 Outcome: 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.
Data Analyses. The primary responses will be continuously distributed, and we will compare the active to sham conditions using linear mixed effects models. For the response of Aim 1, we will possibly transform the responses to reduce levels of skewness. When conducting TEP measurements, the order in which participants receive stimulation will be randomly assigned such that 50% of participants receive stimulation to the DLPFC first and 50% receive stimulation to the TPJ first. For the behavioral responses of Aim 2 we will use Fisher's z-transform to symmetrize the distribution and stabilize the variance. The models will include two-level categorical factors for treatment and period; as the period and treatment factors are categorical, these models accommodate arbitrary treatment effects, and, for example, do not assume a linear trend across the treatments. We will include random intercepts for participant and will check whether additional covariance structure is required to account for within-participant correlations. We will also examine treatment by period interaction effects. If these effects are significant, we will report estimated effects and associated standard errors and p-values separately by period; if the interaction effects are non-significant, then we will report estimates of effect pooled over periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| dlPFC TMS | Experimental | Device: TBSIndividualized 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. |
| TPJ TMS | Experimental | Device: TBSIndividualized 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Able to give their consent
- Right-handed or ambidextrous
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| TBSaiTBS 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). | Device | TPJ TMS, dlPFC TMS |
Primary outcome
Spectral Dynamics
Time frame: 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.
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.
Task Performance
Time frame: 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.
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.
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.
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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, PhD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing TBS in people with Brain Plasticity, 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 15 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?
Spectral Dynamics (time frame: 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.). 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.