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Идёт набор NCT05621538

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Без фазы С лечением Alcohol Use 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: Realtime fMRI Neurofeedback - Active, TMS - Active, Realtime fMRI Neurofeedback - Yoked Sham, TMS - Sham.
Кому может быть актуально
Состояния в реестре: Alcohol Use Disorder. Базовые параметры: 19 лет — 65 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

The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder. After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.

Вмешательства

  • Поведенческое Realtime fMRI Neurofeedback - Active
    fMRI aided reinforcement of craving regulation
  • Устройство TMS - Active
    rTMS to right dorsolateral prefrontal cortex to reduce craving
  • Поведенческое Realtime fMRI Neurofeedback - Yoked Sham
    Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
  • Устройство TMS - Sham
    rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex

Первичные конечные точки

  • Change in Alcohol Use over Time [Срок оценки: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)]
  • Change in Alcohol Craving over Time [Срок оценки: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)]
  • Change in Community Functioning over Time [Срок оценки: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)]
  • Change in Employment Status over Time [Срок оценки: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)]
  • Change in Aggression and Victimization over Time [Срок оценки: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)]
  • Change in Antisocial Behavior over Time [Срок оценки: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)]
  • Change in Brain Activity during Alcohol Cue Presentation over Time [Срок оценки: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)]
  • Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time [Срок оценки: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)]
Вторичные конечные точки (3)
  • Change in Brain Gray Matter Structure over Time [Срок оценки: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)]
  • Change in Brain White Matter Structure over Time [Срок оценки: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)]
  • Change in Resting State Functional Connectivity over Time [Срок оценки: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)]

Критерии участия

Критерии включения

  • Age 19-65
  • Receiving treatment for Alcohol Use Disorder

Критерии исключения

  • MRI Contraindications
  • Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
  • Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
  • Hearing loss, including tinnitus, that might be made worse by MRI or TMS
  • TMS Contraindications
  • Has ever had a seizure, or has a family history of epilepsy
  • Taking medications or substances that lower the seizure threshold
  • Implanted devices that are in the head or rely on physiological signals
  • History of neurological disease, such as stroke or brain tumor
  • Head injury with loss of consciousness greater than 30 minutes
  • Actively withdrawing from alcohol
  • Family history of schizophrenia or presence of psychotic symptoms

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Auburn University — Auburn

Идентификаторы

NCT: NCT05621538 · 22145 · R00AA027830

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗