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Effect of aiTBS on Intrinsic Spectral Dynamics and Task Performance

27 aprile 2026 aggiornato da: University of Pennsylvania

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: dlPFC TMS
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.
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).
Sperimentale: TPJ TMS
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.
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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Spectral Dynamics
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Nicholas L Balderston, PhD, University of Pennsylvania

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 maggio 2030

Completamento dello studio (Stimato)

30 maggio 2030

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 26-6524

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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