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Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture

9 giugno 2026 aggiornato da: University of Colorado, Denver

Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture in Psychopathy

This clinical trial will examine whether transcranial magnetic stimulation (TMS), a noninvasive form of brain stimulation, can influence social cognition, cognitive processing, and brain function in adults with elevated psychopathic traits. The study will also evaluate the safety and feasibility of delivering TMS in this population.

Participants will be randomly assigned to receive either active TMS or sham (placebo-like) TMS. The study will compare outcomes between participants receiving active versus sham TMS and will evaluate changes from before to after TMS exposure.

Participants will:

  • Complete a baseline magnetic resonance imaging (MRI) brain scan.
  • Receive three single-session TMS interventions.
  • Complete a post-intervention MRI brain scan.
  • Complete assessments of social cognition.
  • Complete assessments of cognitive processing.

The primary objectives are to determine whether TMS can influence social cognition, cognitive processing, and functional brain organization and connectivity in adults with elevated psychopathic traits.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Psychopathic traits are associated with impairments in social cognition, cognitive processing, and alterations in functional brain network organization. Neuroimaging studies have implicated abnormalities in brain regions involved in cognitive control and social information processing, including the right dorsolateral prefrontal cortex (dlPFC) and right temporoparietal junction (TPJ). Transcranial magnetic stimulation (TMS) is a noninvasive neuromodulation technique capable of altering neural activity within targeted brain networks and provides an experimental method for examining the causal contribution of these regions to cognitive and social functioning.

This randomized, sham-controlled clinical trial will evaluate whether theta burst stimulation targeting the right dlPFC or right TPJ influences social cognition, cognitive processing, and functional brain network organization in adults with elevated psychopathic traits. Participants will be randomly assigned to receive inhibitory continuous theta burst stimulation (cTBS) targeting the right dlPFC, excitatory intermittent theta burst stimulation (iTBS) targeting the right TPJ, or sham stimulation. Stimulation targets will be individualized using participant-specific neuroimaging data.

Participants will complete baseline and post-intervention assessments that include functional magnetic resonance imaging (fMRI), measures of social cognition, and measures of cognitive processing. Functional neuroimaging will be used to evaluate changes in brain network organization and connectivity associated with stimulation. Behavioral assessments will evaluate social cognitive processes, including emotion processing and perspective taking, as well as cognitive processes related to attention and cognitive control.

Analyses will compare active stimulation conditions with sham stimulation on measures of social cognition and cognitive processing. Neuroimaging analyses will evaluate both within-subject changes from pre- to post-stimulation and between-group differences in functional brain network organization and connectivity.

The primary objectives are to determine whether theta burst stimulation can influence social cognition, cognitive processing, and functional brain network organization in adults with elevated psychopathic traits and to evaluate the safety and feasibility of delivering TMS in this population. Findings from this study may help clarify the neural mechanisms underlying psychopathic traits and inform future development of targeted neuromodulation interventions.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

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

Luoghi di studio

  • Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado Anschutz Medical Campus
        • Contatto:
        • Investigatore principale:
          • Drew E Winters, PhD.

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

No

Descrizione

Inclusion Criteria:

  • 18-60 years.
  • Elevated psychopathy as defined by the self-report psychopathy scale.
  • IQ >= 80.
  • No prior diagnosis or current risk of Autism as defined by the autism spectrum quotient.
  • Negative urine drug screen.
  • At least 7 Days of abstinence from substance use (excluding nicotine)
  • Able to provide informed consent.
  • No change in psychiatric medication regimen, or medication-free, for 4 weeks before study.
  • Adequate English proficiency to complete study procedures and assessments.

Exclusion Criteria:

  • Current or lifetime DSM-5 psychotic disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or autism spectrum disorder.
  • IQ < 80.
  • Clinically significant neurological disorder or medical illness that would make study participation unsafe, including a history of seizures or significant cardiovascular disease.
  • Clinically significant abnormality identified on baseline MRI.
  • Contraindication to MRI or inability to undergo MRI scanning.
  • Current pregnancy or breastfeeding.
  • History of head injury resulting in loss of consciousness greater than 15 minutes.
  • Diagnosis of dementia.
  • Current prescription for benzodiazepines or anticonvulsants.
  • Metal implants or non-removable metal objects above the waist.
  • Lifetime history of prior clinical treatment with transcranial magnetic stimulation (TMS).
  • Serious risk of suicide or homicide.
  • Unable or unwilling to comply with study procedures.
  • History of intractable migraine.
  • Claustrophobia or inability to tolerate enclosed spaces required for MRI procedures.

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: active dlPFC sham TPJ
Subjects in this group will receive active continuous theta burst stimulation (cTBS) to the individually defined region of the dlPFC and sham to the TPJ.
Dispositivo: continuous theta burst stimulation (cTBS)
Continuous theta burst stimulation (cTBS) will be delivered using transcranial magnetic stimulation (TMS) targeting the right dorsolateral prefrontal cortex (dlPFC). cTBS is a patterned form of repetitive TMS designed to modulate neural activity within targeted brain networks involved in cognitive control and social cognition. Stimulation targets will be individualized using participant-specific neuroimaging data.
Comparatore attivo: active TPJ sham dlPFC
Subjects in this group will receive active intermittent theta burst stimulation to the individually defined region of the TPJ and sham to the dlPFC.
Dispositivo: Intermittent theta burst stimulation (iTBS)
Intermittent theta burst stimulation (iTBS) will be delivered using transcranial magnetic stimulation (TMS) targeting the right temporoparietal junction (TPJ). iTBS is a patterned form of repetitive TMS designed to modulate neural activity within targeted brain networks involved in social cognition and perspective taking. Stimulation targets will be individualized using participant-specific neuroimaging data
Comparatore fittizio: sham
Subjects in this group will receive sham stimulation to the dlPFC and TPJ.
Dispositivo: Sham
Sham transcranial magnetic stimulation will be delivered using procedures designed to mimic the sensory experience of active stimulation without producing the intended neuromodulatory effects. Stimulation targets and study procedures will mirror those used in the active intervention arms.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serial and Parallel Cognitive Processing Task Performance
Lasso di tempo: within 10 minutes after the intervention.
Performance on the Miller serial/parallel cognitive processing task. Trial-level accuracy and/or reaction time will be analyzed using mixed-effects models to compare active stimulation versus sham stimulation across serial and parallel processing conditions.
within 10 minutes after the intervention.
Social Cognition Task Battery Performance
Lasso di tempo: within 10 minutes after the intervention.
Performance on a social cognition task battery assessing facial emotion recognition (Emotion Recognition Task), perspective taking (Visual Perspective Taking Task), theory of mind (Movie Assessment of Social Cognition Task), and social decision-making (Altruistic/Antisocial game). Accuracy and reaction time will be analyzed using mixed-effects models to compare active stimulation versus sham stimulation across tasks. Higher accuracy values indicate better performance, whereas lower reaction times indicate better performance.
within 10 minutes after the intervention.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Resting-State Functional Connectivity
Lasso di tempo: From the date of baseline fMRI until the first TMS session, assessed 2 times (baseline and post-TMS) up to 2 months after the baseline session. Post-TMS fMRI scan will be conducted within 30 minutes after the intervention.
Resting-state functional magnetic resonance imaging will be used to evaluate changes in functional connectivity within stimulation-relevant brain networks from baseline to post-intervention. Analyses will examine frontoparietal network connectivity for right dorsolateral prefrontal cortex stimulation and default mode network connectivity for right temporoparietal junction stimulation, including within-subject change and between-group comparisons of active versus sham stimulation.
From the date of baseline fMRI until the first TMS session, assessed 2 times (baseline and post-TMS) up to 2 months after the baseline session. Post-TMS fMRI scan will be conducted within 30 minutes after the intervention.

Collaboratori e investigatori

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

Sponsor

University of Colorado, Denver

Collaboratori

National Institute of Mental Health (NIMH)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

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)

1 giugno 2030

Completamento dello studio (Stimato)

1 agosto 2030

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 24-2634
  • 1K23MH139637-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Upon study completion, neuroimaging and behavioral data will be shared via the brain imaging data sharing database OpenNeuro. Metadata for the study will be included, such as the study protocol.

All publications from this data by the PI or the PI's lab will first preregister the analysis, and all accepted publications will share the analytic code with a link to the GitHub repository in the publication

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

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

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

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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