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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07635940
Status
Not Yet Recruiting

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Conditions

  • Psychopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Social Cognition Task Battery Performance [ Time Frame: within 10 minutes after the intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Drew E Winters, PhD.
303-724-1000
Drew E Winters, PhD. (PRINCIPAL_INVESTIGATOR)

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