High Intensity Alternating Current Stimulation as a Neuromodulation Therapy for Alcohol Use Disorder: A Pilot Study
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: HI-tACS.
- Кому может быть актуально
- Состояния в реестре: Alcohol Use Disorder (AUD). 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
This study aims to explore the efficacy of high intensity transcranial alternating current stimulation on individuals with alcohol use disorders. Utilizing a one-arm pilot study design, participants will undergo transcranial alternating current stimulation.
Подробное описание
Alcohol use disorder (AUD) is become a major social and public health problem in China. Craving for alcohol and compulsive drinking behavior are the main symptom of AUD. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognition, and High-Intensity transcranial Alternating Current Stimulation (HI-tACS) could improve executive-control function thus by adjusting the abnormal synchronization. However, it has not been verified among AUD patients. The investigators assume that tACS could improve AUD patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of HI-tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the craving and alcohol use behavior. This study will provide a practical and theoretical basis for developing a novel treatment for AUD.
Вмешательства
- Устройство HI-tACS
A 40-minute 15mA transcranial alternating current stimulus intervention with 77.5 Hz of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of AUD.
Первичные конечные точки
- The change of alcohol craving [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- The change of drinking behavior [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
Вторичные конечные точки (11)
- The change of drinking urge [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- The change of abstinence symptom [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- Change of the compulsive drinking behavior [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- Side effects of the modulation [Срок оценки: Immediately after the intervention]
- Change of depressive symptoms. [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- Change of anxiety symptoms [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- Change of the sleep quality [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- Change of the self-control ability [Срок оценки: Baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention]
- Change of the risky decision-making performance [Срок оценки: Baseline, two weeks after the intervention.]
- Change of the inhibitory control performance [Срок оценки: Baseline, two weeks after the intervention.]
- Change of the resting state neural activity. [Срок оценки: Baseline, two weeks after the intervention.]
Критерии участия
Критерии включения
- Education level of junior high school or above, capable of completing questionnaires and behavioral tests;
- Aged 18-60 years;
- Meet DSM-5 diagnostic criteria for Alcohol Use Disorder;
- No abnormal findings on physical examination;
- Agree to participate in follow-up assessments;
- No contraindications for MRI scanning.
Критерии исключения
- Have impaired intelligence (Intelligence Quotient<70);
- Prior tDCS or TMS treatment within the past 3 months;
- Contraindications for TMS therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy);
- Severe somatic diseases or major organ dysfunction;
- Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Shanghai Mental Health Center — Шанхай
Идентификаторы
NCT: NCT07227545 · JDu-016