Recruiting

TMS vs. Sham TMS

Sponsor:

University of Colorado, Denver

Code:

NCT07635940

Conditions

Psychopathy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

continuous theta burst stimulation (cTBS)

Intermittent theta burst stimulation (iTBS)

Sham

Study Details

Brief 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.

Conditions

Psychopathy

Study ID

NCT07635940

Start date

Jul 13, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

sham comparator: sham

Subjects in this group will receive sham stimulation to the dlPFC and TPJ.

Interventions

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.

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

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.

Primary outcome measure

  • Social Cognition Task Battery Performance [ Time Frame: within 10 minutes after the intervention. ]
  • Serial and Parallel Cognitive Processing Task Performance [ Time Frame: within 10 minutes after the intervention. ]

Central Contacts and Locations

Central contacts

Drew E Winters, PhD.

303-724-1000ascend@ucdenver.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Drew E Winters, PhD.

303-724-1000ascend@ucdenver.edu

Principal Investigator:

Drew E Winters, PhD.

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • Psychopathy
  • Transcranial Magnetic Stimulation
  • Theta Burst Stimulation
  • Neuromodulation
  • Social Cognition
  • Emotion Recognition
  • Theory of Mind
  • Social Decision Making
  • Cognitive Processing
  • Cognitive Control
  • Executive Function
  • Functional Connectivity
  • Resting-State fMRI
  • Dorsolateral Prefrontal Cortex
  • Temporal Parietal Junction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.