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Набор по приглашению NCT06821646

Investigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography

Наблюдательное Autism Major Depressive Disorder (MDD)

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
В протоколе указаны: Positron Emission Tomography (PET), transcranial magnetic stimulation and electroencephalography(TMS-EEG).
Кому может быть актуально
Состояния в реестре: Autism, Major Depressive Disorder (MDD). Базовые параметры: 20 лет — 50 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Social Cognition in Major Depression and Autism Spectrum Disorder: Cortical Excitatory-inhibitory Imbalance and Neuromechanism

Обзор

The goal of this observational study is to investigate the brain physiological responses in depression and autism. The main questions aim to answer are: 1. Comparing the ratios of cortical excitation and inhibition among four groups: autism group, autism with depression group, depression group, and normal control group using Transcranial magnetic stimulation and electroencephalography (TMS-EEG). This study explores the relationship between the ratios of cortical excitation and inhibition and the severity of clinical symptoms. 2. Comparing the brain inflammation among four groups: autism group, autism with depression group, depression group, and normal control group using Positron emission tomography (PET). This study investigates the relationship between brain inflammation and the severity of clinical symptoms. 3. The mutual influence between the severity of brain inflammation and Excitatory/inhibitory imbalance (E/I imbalance). Participants will receive clinical assessment, neurocognitive function tests, TMS-EEG, gamma oscillation, and PET examinations.

Вмешательства

  • Диагностический тест Positron Emission Tomography (PET)
    18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
  • Диагностический тест transcranial magnetic stimulation and electroencephalography(TMS-EEG)
    single pulse and paired pulse

Первичные конечные точки

  • Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET) [Срок оценки: 1 hour]
  • Standardized Uptake Value (SUV) of Translocator Protein activity recorded by transcranial magnetic stimulation and electroencephalography(TMS-EEG) [Срок оценки: 2 hours]
Вторичные конечные точки (1)
  • the total composite scores of multiple scales [Срок оценки: 2 hours]

Критерии участия

Критерии включения

  • Autism group : Adults aged 20-50 diagnosed with autism spectrum disorder。Intelligence Quotient(IQ) > 70, with autonomous abilities.
  • Autism group with comorbid depression : Adults aged 20-50 diagnosed with autism spectrum disorder. Diagnosed with depression. IQ > 70. Not on antidepressants for at least one week, with autonomous abilities.
  • Major depression disorder group : Adults aged 20-50. Diagnosed with major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-TR(DSM-IV-TR). IQ > 70. Not on antidepressants for at least one week, with autonomous abilities.
  • Typically developing control group : Adults aged 20-50. Never diagnosed with autism spectrum disorder. Never diagnosed with depression. IQ > 70, with autonomous abilities.

Критерии исключения

  • Previously diagnosed with bipolar disorder, schizophrenia, attention deficit hyperactivity disorder (ADHD), or substance use disorder according to DSM-IV.
  • Previously suffered from major medical or neurological diseases.
  • Brain structural abnormalities (e.g., brain tumor or arteriovenous malformations) or neurological diseases (e.g., meningitis, encephalitis, stroke, or epilepsy).
  • Previously undergone or soon to undergo brain surgery, or have metal implants in the head or neck area, such as neuro-stimulators or cochlear implants.
  • Have a cardiac pacemaker.
  • Pregnant participants.
  • Participants with strong suicidal intentions.
  • Other conditions that render the patient unable to cooperate, such as unsuitability after screening, unstable physical illness, or refusal to sign the informed consent.
  • Claustrophobia, unable to undergo positron emission tomography(PET) and functional magnetic resonance imaging (fMRI) scans.
  • Taking medications that may affect Excitatory/inhibitory balance (E/I balance).

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06821646 · 202209019DINB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗