PsychopathyNCT07635940

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

A study testing continuous theta burst stimulation (cTBS) and Intermittent theta burst stimulation (iTBS) in people with Psychopathy, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Psychopathy
What is being tested?: continuous theta burst stimulation (cTBS) and Intermittent theta burst stimulation (iTBS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 13 Jul 2026to Aug 2030
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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)

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Drew E Winters, PhD. contact

303-724-1000

ascend.lab@cuanschutz.edu

United States1 site, 1 recruiting

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Drew E Winters, PhD., 303-724-1000, ascend.lab@cuanschutz.edu
Drew E Winters, PhD.
Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions: Psychopathy
Being tested: continuous theta burst stimulation (cTBS), Intermittent theta burst stimulation (iTBS), Sham
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
Medical subject headings: Antisocial Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
ShamDevice
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.

Study groups in NCT07635940
Study group	Role	What they receive
active dlPFC sham TPJ	Active comparator	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. Receives: Device: continuous theta burst stimulation (cTBS)
active TPJ sham dlPFC	Active comparator	Subjects in this group will receive active intermittent theta burst stimulation to the individually defined region of the TPJ and sham to the dlPFC. Receives: Device: Intermittent theta burst stimulation (iTBS)
sham	Sham comparator	Subjects in this group will receive sham stimulation to the dlPFC and TPJ. Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Social Cognition Task Battery Performance
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.
Measured: within 10 minutes after the intervention.
Serial and Parallel Cognitive Processing Task Performance
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.
Measured: within 10 minutes after the intervention.

Secondary outcomes (1)

Change in Resting-State Functional Connectivity
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 2026Aug 2030

First posted9 Jun 2026
Study start13 Jul 2026
Primary completionJun 2030 (estimated)
Study completionAug 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for PsychopathyStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to one of three parallel study arms: continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex, intermittent theta burst stimulation (iTBS) targeting the right temporoparietal junction, or sham stimulation. Participants will remain in their assigned intervention arm throughout the study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07635940
Sponsor's protocol ID: 24-2634
Other IDs: 1K23MH139637-01
Status last verified: Oct 2026
First submitted: 29 May 2026
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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

Publications

Tillem S, Weinstein H, Baskin-Sommers A. Psychopathy is associated with an exaggerated attention bottleneck: EEG and behavioral evidence from a dual-task paradigm. Cogn Affect Behav Neurosci. 2021 Aug;21(4):881-893. doi: 10.3758/s13415-021-00891-z. Epub 2021 Apr 5.
PubMed 33821459
Jeurissen D, Sack AT, Roebroeck A, Russ BE, Pascual-Leone A. TMS affects moral judgment, showing the role of DLPFC and TPJ in cognitive and emotional processing. Front Neurosci. 2014 Feb 13;8:18. doi: 10.3389/fnins.2014.00018. eCollection 2014.
PubMed 24592204
Saxe R, Kanwisher N. People thinking about thinking people. The role of the temporo-parietal junction in "theory of mind". Neuroimage. 2003 Aug;19(4):1835-42. doi: 10.1016/s1053-8119(03)00230-1.
PubMed 12948738
Drayton LA, Santos LR, Baskin-Sommers A. Psychopaths fail to automatically take the perspective of others. Proc Natl Acad Sci U S A. 2018 Mar 27;115(13):3302-3307. doi: 10.1073/pnas.1721903115. Epub 2018 Mar 12.
PubMed 29531085
Song Z, Jones A, Corcoran R, Daly N, Abu-Akel A, Gillespie SM. Psychopathic traits and theory of mind task performance: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2023 Aug;151:105231. doi: 10.1016/j.neubiorev.2023.105231. Epub 2023 May 10.
PubMed 37172923