Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture in Psychopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Social Cognition Task Battery Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years.
- •Elevated psychopathy as defined by the self-report psychopathy scale.
- •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.
排除标准
- •Current or lifetime DSM-5 psychotic disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or autism spectrum disorder.
- •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.
研究组 & 干预措施
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.
干预措施: continuous theta burst stimulation (cTBS) (Device)
sham
Subjects in this group will receive sham stimulation to the dlPFC and TPJ.
干预措施: Sham (Device)
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.
干预措施: Intermittent theta burst stimulation (iTBS) (Device)
结局指标
主要结局
Social Cognition Task Battery Performance
时间窗: 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.
次要结局
未报告次要终点