Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture
Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture in Psychopathy
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.
Обзор исследования
Статус
Условия
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Drew E Winters, PhD.
- Номер телефона: 303-724-1000
- Электронная почта: ascend@ucdenver.edu
Места учебы
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- University of Colorado Anschutz Medical Campus
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Контакт:
- Drew E Winters, PhD.
- Номер телефона: 303-724-1000
- Электронная почта: ascend@ucdenver.edu
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Главный следователь:
- Drew E Winters, PhD.
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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.
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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.
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Активный компаратор: 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.
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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
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Фальшивый компаратор: sham
Subjects in this group will receive sham stimulation to the dlPFC and TPJ.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Serial and Parallel Cognitive Processing Task Performance
Временное ограничение: within 10 minutes after the intervention.
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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.
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within 10 minutes after the intervention.
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Social Cognition Task Battery Performance
Временное ограничение: within 10 minutes after the intervention.
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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.
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within 10 minutes after the intervention.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Resting-State Functional Connectivity
Временное ограничение: 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.
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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.
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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.
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие 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.
- 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.
- 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.
- 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.
- 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.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- Нейромодуляция
- Транскраниальная магнитная стимуляция
- Исполнительная функция
- Когнитивный контроль
- Стимуляция тета-всплеска
- Социальное познание
- Дорсолатеральная префронтальная кора
- Теория разума
- Распознавание эмоций
- Функциональная связь
- Психопатия
- Когнитивная обработка
- Social Decision Making
- Resting-State fMRI
- Temporal Parietal Junction
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 24-2634
- 1K23MH139637-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Upon study completion, neuroimaging and behavioral data will be shared via the brain imaging data sharing database OpenNeuro. Metadata for the study will be included, such as the study protocol.
All publications from this data by the PI or the PI's lab will first preregister the analysis, and all accepted publications will share the analytic code with a link to the GitHub repository in the publication
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .