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Идёт набор NCT06325813

ADHD PreSMA Response Inhibition Therapy

Без фазы С лечением Attention Deficit Hyperactivity Disorder

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: Active repetitive TMS, Sham repetitive TMS.
Кому может быть актуально
Состояния в реестре: Attention Deficit Hyperactivity Disorder. Базовые параметры: 12 лет — 17 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
США
Следующий шаг
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Обзор

ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.

Подробное описание

ADHD children (ages 12-17 years) will be recruited. Cognitive testing and basic anatomic brain MRI will be performed during visit 1. During visit 2, baseline TMS-based physiologic measures will be obtained. Children will also complete a behavioral task (stop signal task) while electroencephalography (EEG) data is collected. After these baseline measures, two trains of Intermittent Theta Burst Stimulation (iTBS) will be delivered. (Intermittent Theta Burst Stimulation is a form of repetitive TMS.) The first train of iTBS will be randomized to sham vs. active in a 1:1 ratio. The second train of iTBS is active for all participants. After both iTBS trains are completed, repeat TMS-based measures, stop signal task and EEG data will be collected again. Visit 3 will be one week after visit 2. Visit 3 is a virtual computer-based visit to assess for any potential side effects.

Вмешательства

  • Устройство Active repetitive TMS
    In this study, ADHD children will receive two trains of intermittent theta burst stimulation. Intermittent theta burst stimulation is a form of repetitive TMS. Both iTBS trains will be active stimulation using the active TMS coil.
  • Устройство Sham repetitive TMS
    In this study, ADHD children will receive two trains of intermittent theta burst stimulation. Intermittent theta burst stimulation is a form of repetitive TMS. The first iTBS train will be sham stimulation using the sham TMS coil. The second iTBS train will be active stimulation using the active TMS coil.

Первичные конечные точки

  • TMS-based Short-Interval Intracortical Inhibition (SICI) [Срок оценки: Immediately after each iTBS train]
  • EEG-based beta activity [Срок оценки: Immediately after each iTBS train]
  • TMS-based Cortical Silent Period (cSP) [Срок оценки: Immediately after each iTBS train]
  • EEG-based alpha activity [Срок оценки: Immediately after each iTBS train]
Вторичные конечные точки (1)
  • Stop Signal Reaction Time [Срок оценки: Immediately after each iTBS train]

Критерии участия

Критерии включения

  • ADHD diagnosis
  • Ages 12-17 years
  • Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit

Критерии исключения

  • Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition
  • Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)
  • For biological females who are post-menarche, current pregnancy based on urine pregnancy test.
  • Baseline problem of hearing impairment or chronic tinnitus
  • Any clinically significant finding on brain MRI
  • History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder
  • Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)
  • Neuroleptic/antipsychotic medication(s)
  • Inability to undergo MRI
  • Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician
  • Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication

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
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT06325813 · CIN001 - ADHD PreSMART

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗