Psychopathy
Conditions
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
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.
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.
Interventions
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.
DEVICEIntermittent 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
DEVICESham
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.
Sponsors
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Cognition Task Battery Performance | within 10 minutes after the intervention. | 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. |
| Serial and Parallel Cognitive Processing Task Performance | within 10 minutes after the intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Contacts
CONTACTDrew E Winters, PhD.
Outcome results
None listed