Меню
Идёт набор NCT07219810

Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD

Без фазы С лечением ADHD

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: intermittent theta burst stimulation (iTBS).
Кому может быть актуально
Состояния в реестре: ADHD. Базовые параметры: 12 лет — 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The objective of this project is to examine the differential therapeutic effect of intermittent theta burst stimulation (iTBS; a type of repetitive transcranial magnetic stimulation) to the left DLPFC versus right PreSMA in modulating working memory (WM) versus inhibitory control (IC) deficits. Fifty adolescents (12-18 years old) with parent-reported WM and IC deficits and diagnosed ADHD will be randomized to DLPFC or PreSMA targeted 3x-daily iTBS for a total of ten days (30 total sessions).

Вмешательства

  • Устройство intermittent theta burst stimulation (iTBS)
    Device: Stimulation will be delivered using a Nexstim NBT System 2 device. Motor Threshold: The iTBS pulse intensity will be set at 80% of resting motor threshold (MT). The iTBS protocol will administer 2-second trains with an 8-second inter-burst interval for 1800 pulses \[600 bursts\]), in 50 Hz bursts at 5 Hz (i.e., 200 ms intervals). Each session will last approximately nine minutes. As three sessions will be administered per day, there will be a 20-30 minutes break between each of the nine-

Первичные конечные точки

  • EEG, source-localized oscillatory beta band bursting during SST/SWMT [Срок оценки: Visit 13, approximately 1-2 days after iTBS]
  • fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST/NBT [Срок оценки: Visit 13, approximately 1-2 days after iTBS]
  • Task-based WM/IC performance on SWMT/N-Back/SST [Срок оценки: Visit 13, approximately 1-2 days after iTBS]
  • Rater-Based WM/IC symptoms (BRIEF-2) [Срок оценки: Visit 13, approximately 1-2 days after iTBS]

Критерии участия

Критерии включения

  • Age 12-18 years
  • English fluency of participant and parent and able to provide informed consent/assent
  • Clinical diagnosis of ADHD and confirmation of diagnostic criteria on the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders, Child and Adolescent Version (DIAMOND-KID)
  • Parent rating on The Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2), Parent Form: Working Memory scale T-Score > 60 AND Inhibition scale T-Score > 60
  • IQ > 70

Критерии исключения

Participants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude participants in whom MRI or TMS might result in increased risk of side effects or complications. Common contraindications include metallic hardware in the body, cardiac pacemaker, patients with an implanted medication pumps or an intracardiac line, or prescription of medications known to lower seizure threshold. These account for most of the exclusion criteria listed below:

  • Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
  • History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
  • Any progressive (e.g., neurodegenerative) neurological disorder
  • Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
  • Non-removable makeup or piercings
  • Pacemaker, implanted medication pump, or ventriculo-peritoneal shunt
  • Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit
  • Signs of increased intracranial pressure
  • Intracranial lesion
  • History of head injury resulting in prolonged loss of consciousness
  • Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)
  • Chronic treatment with prescription medications that decrease cortical seizure threshold, not including psychostimulant medication if deemed to be medically safe as part of the medical review process.
  • Active psychosis or mania
  • Acute suicidal intent
  • Current pregnancy
  • Significant visual, hearing or speech impairment
  • Dental braces
  • Current wards of the state

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
Лечение

Центры проведения

США · 1 центр
  • E. P. Bradley Hospital — East Providence

Идентификаторы

NCT: NCT07219810 · 2323018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗