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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство continuous theta burst stimulation (cTBS)
  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.
• Устройство Intermittent 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
• Устройство Sham
  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.

Первичные конечные точки

• Social Cognition Task Battery Performance [Срок оценки: within 10 minutes after the intervention.]
• Serial and Parallel Cognitive Processing Task Performance [Срок оценки: within 10 minutes after the intervention.]

Вторичные конечные точки (1)

• Change in Resting-State Functional Connectivity [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Colorado Anschutz Medical Campus — Aurora

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07635940 · 24-2634 · 1K23MH139637-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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