Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial
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, Sham stimulation.
- Кому может быть актуально
- Состояния в реестре: Gambling Disorder. 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
The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.
Подробное описание
Gambling disorder has become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addictions such as gambling disorder. Previous studies have demonstrated that abnormal neural activity is distributed across multiple brain regions and networks throughout the whole brain. Research has shown that abnormal neural activity, particularly in the gamma band, contributes to executive-control deficits. High-intensity transcranial Alternating Current Stimulation (HI-tACS) has been found to improve executive-control function by modulating this abnormal gamma-band activity. However, this has not yet been verified in gambling disorder patients. The investigators assume that HI-tACS could improve gambling disorder patients' executive-control function by modulating abnormal gamma-band neural activity, which is closely associated with executive-control deficits. This study intends to test the effect of HI-tACS treatment, which was discovered in a previous pilot study. A three-month follow-up assessment will be conducted to examine changes in executive-control function and its underlying mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.
Вмешательства
- Устройство HI-tACS
Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. The frequency of stimulation is 77.5Hz, and the current is 15mA. - Устройство Sham stimulation
Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The appearance of the above-mentioned equipment is identical to that of the real stimulation group devices, but it only simulates the electrical sensation produced at the beginning and end of stimulation.
Первичные конечные точки
- Change of the gambling 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]
Вторичные конечные точки (10)
- 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 gambling 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]
- Side effect of the modulation [Срок оценки: Immediately 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 gambling symptom severity [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, immediately after the intervention.]
- Change of the inhibitory control performance [Срок оценки: Baseline, immediately after the intervention.]
- Change of the resting state neural activity. [Срок оценки: Baseline, immediately after the intervention.]
Критерии участия
Критерии включения
- Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests;
- Meet DSM-5 (Diagnostic and Statistical Manual of mental disorders，DSM) diagnostic criteria for gambling disorder;
- Have gambled for at least one year (at least once a week);
- Normal vision and hearing, or within the normal range after correction;
- Agree to cooperate in the follow-up evaluation;
- No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity.
Критерии исключения
- Have severe cognitive impairment, such as a history of head trauma, -cerebrovascular disease, epilepsy, etc.;
- Have used drugs promoting cognitive function in the last 6 months;
- Have impaired intelligence (Intelligence Quotient<70);
- Abuse or dependence of psychoactive substances (except nicotine) in the last 5 years.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Shanghai Mental Health Center — Шанхай
Идентификаторы
NCT: NCT07228182 · JDu-017