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) — DEVICEContinuous 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) — DEVICEIntermittent 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 — DEVICESham 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 TPJSubjects 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 dlPFCSubjects 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: shamSubjects 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
- Drew E Winters, PhD.303-724-1000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | Drew E Winters, PhD. (PRINCIPAL_INVESTIGATOR) |