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

NCT07635940 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 24-26341K23MH139637-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  within 10 minutes after the intervention.

Secondary Outcomes (1)

• Change in Resting-State Functional Connectivity

  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.

Study Arms (3)

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.

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.

Device: Intermittent theta burst stimulation (iTBS)

sham

SHAM COMPARATOR

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

Device: Sham

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.

active dlPFC sham TPJ

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.

sham

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

active TPJ sham dlPFC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

• 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.

  PMID: 33821459 BACKGROUND

• 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.

  PMID: 24592204 BACKGROUND

• 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.

  PMID: 12948738 BACKGROUND

• 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.

  PMID: 29531085 BACKGROUND

• 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.

  PMID: 37172923 BACKGROUND

Related Links

• NIH reporter

MeSH Terms

Conditions

Antisocial Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Drew E Winters, PhD.

CONTACT

303-724-1000; ascend@ucdenver.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, TMS technicians administering stimulation, investigators, and outcomes assessors will be masked to intervention assignment. Active and sham stimulation assignments will be implemented using study procedures designed to preserve masking across intervention arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US (1)