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NCT07635940
Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture
Conditions: Psychopathy
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: University of Colorado, Denver
Location: University of Colorado Anschutz Medical Campus Aurora Colorado
Summary
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.
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.
Source: ClinicalTrials.gov (NCT07635940). StuddyBuddy aggregates publicly available trial information.