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

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • University of Colorado Anschutz Medical Campus
        • Kontakt:
        • Hauptermittler:
          • Drew E Winters, PhD.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Gerät: 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.
Aktiver Komparator: 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.
Gerät: 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
Schein-Komparator: sham
Subjects in this group will receive sham stimulation to the dlPFC and TPJ.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serial and Parallel Cognitive Processing Task Performance
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Resting-State Functional Connectivity
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Colorado, Denver

Mitarbeiter

National Institute of Mental Health (NIMH)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2030

Studienabschluss (Geschätzt)

1. August 2030

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 24-2634
  • 1K23MH139637-01 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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