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Идёт набор NCT06976879

Intra- and Interindividual Moderators of Prefrontal Excitability Investigated Using Simultaneous TMS With Neuroimaging

— Наблюдательное Healthy Adults

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Healthy Adults. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The simultaneous application of brain stimulation and neuroimaging offers significant potential for advancing basic neuroscience research and developing objective diagnostic and prognostic markers for mental disorders. The University Research Facility in Behavioral and Systems Neuroscience (UBSN), in collaboration with Principal Investigator Dr. Georg Kranz, recently acquired a TMS-compatible Magnetic Resonance Imaging (MRI) radio-frequency head coil. This cutting-edge equipment, developed by Dr. Martin Tik's research lab in Vienna, enables detailed mapping of both local and remote neural effects of intermittent theta-burst stimulation (iTBS)-a non-pharmacological treatment with proven efficacy for mental disorders. The upgraded setup addresses limitations of older concurrent TMS-fMRI systems, which struggled with image quality and practical applicability. The new system incorporates a multi-channel receiver array, allowing for high-resolution imaging at a fast rate. In this design, the TMS coil is positioned outside the imaging coil, with stimulation pulses passing through the thin imaging coil to reach the participant's brain and induce targeted neural changes. This advanced system enables the investigation of therapeutic network changes induced by iTBS by capturing acute brain responses during stimulation. Additionally, its sensitivity allows for dose-response assessments at the individual subject level. To leverage these advancements, pilot studies utilizing concurrent rTMS/fMRI are proposed to investigate intra- and interindividual moderators of therapeutic brain stimulation. The iTBS/fMRI study will focus on stimulation-induced hemodynamic changes in key subcortical structures and networks that mediate therapeutic responses to iTBS. Specifically, the study aims to examine changes in central limbic regions, including the subgenual anterior cingulate cortex (sgACC), anterior insula, amygdala, ventromedial prefrontal cortex, and orbitofrontal cortex. By exploring these regions, the mechanisms underlying the therapeutic effects of rTMS can be elucidated, providing a comprehensive understanding of how acute brain responses translate into clinical outcomes. This approach represents a significant step forward in advancing the understanding of iTBS, with the potential to refine and optimize this treatment for mental disorders.

Первичные конечные точки

  • BOLD signals [Срок оценки: Before stimulation (3-5 minutes), during stimulation (3-5 minutes), and post-stimulation (up to 15 minutes after iTBS completion) on visit 2 and visit 3]
Вторичные конечные точки (12)
  • Age [Срок оценки: visit 1]
  • Gender [Срок оценки: visit 1]
  • Caffeine consumption [Срок оценки: Before stimulation on visit 2 and visit 3]
  • Mood states [Срок оценки: Before stimulation on visit 2 and visit 3]
  • Physical activity [Срок оценки: Before stimulation on visit 2 and visit 3]
  • Sleep quality [Срок оценки: Before stimulation on visit 2 and visit 3]
  • Time of the experiment [Срок оценки: Before stimulation on visit 2 and visit 3]
  • Working Memory [Срок оценки: After stimulation on visit 2 and visit 3]
  • Vigilance [Срок оценки: After stimulation on visit 2 and visit 3]
  • Attention [Срок оценки: After stimulation on visit 2 and visit 3]
  • Childhood maltreatment [Срок оценки: Visit 1]
  • Family history in first-degree relatives [Срок оценки: Visit 1]

Критерии участия

Критерии включения

  • consider yourself healthy in general and aged 18-60

Критерии исключения

  • current internal illness;
  • current or former psychiatric or neurological illness;
  • current or former alcohol or substance abuse;
  • current or previous use of any psychotropic medication;
  • current or previous use of any illicit drug;
  • any ferromagnetic metal in your body;
  • known or possible pregnancy, including the situation when the first day of a
  • female's last menstrual period was more than 28 days ago; or
  • any contraindication to TMS as assessed by Rossi et al.'s (2011) screening questionnaire.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06976879 · HSEARS20231218001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗