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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Colorado, Denver • ClinicalTrials.gov ID: NCT07635940

Registry updated: 2026-10-08
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Description

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.

Interventions

  • continuous theta burst stimulation (cTBS) (Device)
    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.
  • Intermittent theta burst stimulation (iTBS) (Device)
    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
  • Sham (Device)
    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.

Eligibility criteria

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.

Conditions

Psychopathy

Locations

  • University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record